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| # | nctid | status | why_stop | label | phase | diseases | icdcodes | drugs | smiless | criteria |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00561392 | completed | 1 | phase 4 | ["alzheimer's disease"] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['rivastigmine 5 and 10 cm^2 patch'] | ['Status: 503'] | Inclusion Criteria: - Males, and females not of child-bearing potential (surgically sterile or at least one year postmenopausal), of at least 50 years of age - Probable Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria - MMSE (Mini-Mental State Examination) score of > 10 and < 26 - Patients initiating therapy for the first time with a cholinesterase inhibitor (patients prescribed both rivastigmine and memantine are allowed) - Patients who failed to benefit from previous cholinesterase inhibitor treatment Exclusion Criteria: - Patients not treated according to the product monograph for rivastigmine capsules - patients involved in a clinical trial - Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application) Other protocol-defined exclusion criteria applied to the study. | |
| 2 | NCT00381719 | completed | 0 | phase 2 | ['diabetic neuropathy, painful'] | ["['G58.0', 'G61.1', 'A52.15', 'G60.3', 'G61.82', 'H46.2', 'H46.3']"] | ['agn 203818', 'agn 203818', 'agn 203818', 'placebo capsule'] | ['Status: 503', 'Status: 503', 'Status: 503', 'Status: 503'] | Inclusion Criteria: - Diagnosis of diabetic peripheral neuropathy - Moderate to severe neuropathic pain Exclusion Criteria: - Any other uncontrolled disease - Pregnant or nursing females | |
| 3 | NCT00510913 | completed | 1 | phase 4 | ['graft rejection', 'kidney transplantation'] | ["['T86.830', 'T86.820']", "['N26.2', 'Q63.0', 'Q63.2', 'Z52.4', 'I75.81', 'N19', 'N20.0']"] | ['tacrolimus'] | ['Status: 503'] | Inclusion Criteria: - Patient has been on cyclosporine-based immunosuppression regimen since the transplant - Patient has at least one pre-defined risk factor for chronic allograft failure Exclusion Criteria: - Patient is dialysis dependent - Patient is recipient of a solid organ transplant other than the kidney | |
| 4 | NCT01568073 | completed | 1 | phase 3 | ["parkinson's disease"] | ["['G20']"] | ['bia 9-1067', 'entacapone', 'placebo', 'levodopa', 'carbidopa', 'benserazide'] | ['CC1=C(C(=[N+](C(=C1Cl)C)[O-])Cl)C2=NOC(=N2)C3=CC(=C(C(=C3)O)O)[N+](=O)[O-]', 'CCN(CC)C(=O)C(=CC1=CC(=C(C(=C1)O)O)[N+](=O)[O-])C#N', 'C1=CC(=C(C=C1CC(C(=O)O)N)O)O', 'CC(CC1=CC(=C(C=C1)O)O)(C(=O)O)NN', 'C1=CC(=C(C(=C1CNNC(=O)C(CO)N)O)O)O'] | Inclusion Criteria: V1 (Screening, up to 14 days before V2) - Able to comprehend and willing to sign an informed consent form. - Male and female subjects between 30 and 83 years old, inclusive. - Diagnosed with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for at least 3 years. - Disease severity Stages I-III (modified Hoehn &Yahr staging) at ON. - Treated with L-DOPA/DDCI for at least 1 year with clear clinical improvement as per investigator's judgment. - Treated with 3 to 8 daily doses of L-DOPA/DDCI, which can include a slow-release formulation. - On a stable regimen of L-DOPA/DDCI and other anti-PD drugs for at least 4 weeks before screening. - Signs of "wearing-off" phenomenon (end-of-dose deterioration) for a minimum of 4 weeks before screening, with average total daily OFF time while awake of at least 1.5 hours, excluding the early morning pre-first dose OFF, despite optimal anti-PD therapy (based on the investigator's judgment). - Able to keep reliable diaries of motor fluctuations (alone or with family/caregiver assistance). - Amenorrheic for at least 1 year or surgically sterile for at least 6 months before screening. Females of childbearing potential must be using an effective non-hormonal contraceptive method. V2 (Randomisation, Day 0) - Have filled-in self-rating diary charts in accordance with the diary chart instructions and with ≤ 3 errors per day. - At least 1.5 OFF hours per day, excluding the early morning pre-first dose OFF period (i.e. the time between wake-up and response to the first L DOPA/DDCI dosage), as recorded in the self-rating diary for at least 2 of the 3 days preceding V2. - Results of the screening laboratory tests are considered acceptable by the investigator (i.e. not clinically relevant for the well-being of the subject or for the purpose of the study). Exclusion Criteria: V1 (Screening, up to 14 days before V2) - Non-idiopathic PD (atypical parkinsonism, secondary [acquired or symptomatic] parkinsonism, Parkinson-plus syndrome). - Dyskinesia disability score > 3 in the Unified Parkinson's Disease Rating Scale (UPDRS) Sub-section IV A, item 33. - Severe and/or unpredictable OFF periods. - Treatment with prohibited medication: tolcapone, neuroleptics, venlafaxine, monoamine oxidase inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1 mg/day), or antiemetics with antidopaminergic action (except domperidone) within the month before screening. - Previous use of entacapone. - Treatment with apomorphine, alpha-methyldopa, or reserpine within the month before screening or likely to be needed at any time during the study. - Dosage change of concomitant anti-PD medication within 4 weeks of screening. - Previous or planned (during the entire study duration, including the OL period) deep brain stimulation. - Previous stereotactic surgery (e.g. pallidotomy, thalamotomy) for PD or with planned stereotactic surgery during the study period. - Any IMP within the 3 months (or within 5 half-lives, whichever is longer) before screening. - Any medical condition that might place the subject at increased risk or interfere with assessments. - Past (within the past year) or present history of suicidal ideation or suicide attempts. - Current or previous (within the past year) diagnosis of major depressive disorder, mania, bipolar disorder, psychosis, dysthymia, generalised anxiety disorder, alcohol or substance abuse excluding caffeine or nicotine, impulse control disorders (e.g. pathological gambling), dementia or eating disorders according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV) American Psychiatric Association, 2000 criteria, as determined by the investigator. - A clinically relevant electrocardiogram (ECG) abnormality (relevance should be assessed by a cardiologist if needed). - Current evidence of unstable cardiovascular disease, including but not limited to uncontrolled hypertension, myocardial infarction with important systolic or diastolic dysfunction, unstable angina, congestive heart failure (New York Heart Association class ≥ III), and significant cardiac arrhythmia (Mobitz II 2nd or 3rd degree AV block or any other arrhythmia causing haemodynamic repercussions as symptomatic bradycardia or syncope). - Prior renal transplant or current renal dialysis. - Pheochromocytoma, paraganglioma, or other catecholamine secretive neoplasm. - Known hypersensitivity to the ingredients of IMPs used. - History of neuroleptic malignant syndrome (NMS) or NMS-like syndromes, or non-traumatic rhabdomyolysis. - History of or current cancer disease, which in the investigator's opinion would exclude the subject from the study (e.g. melanoma, prostate cancer). - Unstable active narrow-angle or unstable wide-angle glaucoma. - History of or current evidence of any relevant disease in the context of this study, i.e. with respect to the safety of the subject or related to the study conditions, e.g. which may influence the absorption or metabolism (such as a relevant liver disease) of the IMP. - Pregnant or breastfeeding. V2 (Randomisation, Day 0) - Any abnormality in the liver enzymes (alanine aminotransferase and/or aspartate aminotransferase) > 2 times the upper limit of the normal range, in the screening laboratory tests results. - Plasma sodium < 130 mmol/L, white blood cell count < 3000 cells/mm3, or any other relevant clinical laboratory abnormality in the screening laboratory tests results that, in the investigator's opinion, may compromise the subject's safety. - Inadequate compliance to concomitant L-DOPA/DDCI and other anti-PD drugs during the Screening period. | |
| 5 | NCT00216437 | terminated | lack of accrual | 0 | phase 1 | ['cancer of liver'] | ["['D13.4', 'Z85.05', 'C22.8', 'C78.7', 'D37.6', 'C22.9']"] | ['capecitabine (xeloda)'] | ['CCCCCOC(=O)NC1=NC(=O)N(C=C1F)C2C(C(C(O2)C)O)O'] | Inclusion Criteria: - Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. - Age >18 years - Ambulatory outpatients (if applicable), with Karnofsky performance status of >60 - Histologically or cytologically confirmed unresectable hepatocellular carcinoma, liver mets with no evidence of extrahepatic disease, or cholangiocarcinoma. (see exclusion criteria 10) - At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques. - Protocol Specific Laboratory Values as described below in section 6.9 number15. - Has a negative serum pregnancy test within 7 days prior to start of therapy (female patients of childbearing potential). - Have concomitant medications been reviewed with patient to address contraindicated medications described in protocol section 6.2.8 and have precautions been taken as recommended for each drug? Includes Allopurinol, Cimetidine, Sorivudine and Brivudine, Anticoagulants, Phenytoin, and Laxatives. Exclusion Criteria: - Pregnant or lactating woman. Woman of childbearing potential with either a positive or no pregnancy test at baseline. Woman or men of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients will agree to continue contraception for 30 days from the date of the last study drug administration - Life expectancy < 3 months. - Serious, uncontrolled, concurrent infection(s). - Any prior fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 12 months earlier). - Prior unanticipated severe reaction to fluoropyrimidine therapy, known sensitivity to 5-fluorouracil or known DPD deficiency. - Completion of previous chemotherapy regimen < four weeks prior to the start of study treatment, or with related toxicities unresolved prior to the start of study treatment. - Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer. - Participation in any investigational drug study within 4 weeks preceding the start of study treatment. - Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months. - Evidence of extrahepatic disease or history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake - Other serious uncontrolled medical conditions that the investigator feels might compromise study participation. - Major surgery within 4 weeks of the start of study treatment, without complete recovery. - Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome. - Known, existing uncontrolled coagulopathy - Any of the following laboratory values: - Abnormal hematologic values (neutrophils < 1.5 x 109/L, platelet count < 100 x 109/L) - Impaired renal function (estimated creatinine clearance <50ml/min as calculated with Cockroft-Gault equation. - Serum bilirubin > 2.0 x upper normal limit. - AST, ALT (SGOT/SGPT) > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases). - Alkaline phosphatase > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases). - Unwillingness to give written informed consent or provide HIPAA privacy authorization. - Unwillingness to participate or inability to comply with the protocol for the duration of the study. - Patient taking a contraindicated medication(s) described in section 6.2.8 (see inclusion criteria #8 for list of agents) and no appropriate substitute agent is available, or patient unable or refuses to take substitute agent. |
| 6 | NCT00696384 | completed | 1 | phase 3 | ['hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['azilsartan medoxomil', 'azilsartan medoxomil, with or without chlorthalidone and other non-angiotensin ii receptor blocker antihypertensive medications.', 'placebo'] | ['CCOC1=NC2=CC=CC(=C2N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NOC(=O)N5)C(=O)OCC6=C(OC(=O)O6)C'] | Inclusion Criteria 1. Has essential hypertension (diastolic blood pressure ≥ 95mm Hg and ≤ 119 mm Hg. For participants with diabetes or chronic kidney disease diastolic blood pressure must be ≥ 85 mm Hg and ≤ to 109 mm Hg. 2. Female participant is not of childbearing potential (eg, sterilized, postmenopausal). 3. Female participants of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. 4. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) are within the reference range for the testing laboratory unless the results are deemed not clinically significant for inclusion into this study by the investigator. Exclusion Criteria 1. Systolic blood pressure greater than 185 mm Hg. 2. Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including: 3. Is hypersensitive to AII receptor blockers. 4. Recent history (within the last 6 months) of myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, cerebrovascular accident, or transient ischemic attack. 5. History of moderate to severe heart failure or hypertensive encephalopathy. 6. Has clinically significant cardiac conduction defects (eg, third-degree atrioventricular block, sick sinus syndrome). 7. Has secondary hypertension of any etiology. 8. Known or suspected unilateral or bilateral renal artery stenosis. 9. Has severe renal dysfunction or disease (based on calculated creatinine clearance < 30 mL/min/1.73 m2) at Screening. | |
| 7 | NCT00464243 | completed | 1 | phase 3 | ['sleep initiation and maintenance disorders'] | ["['Y93.E9', 'Y93.H9']"] | ['volinanserin', 'placebo'] | ['COC1=CC=CC(=C1OC)C(C2CCN(CC2)CCC3=CC=C(C=C3)F)O'] | Inclusion Criteria: - Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria - Disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month - Specific criteria based on the NPSG recordings during the screening nights Exclusion Criteria: - Females who are lactating or who are pregnant - Night shift workers, and individuals who nap 3 or more times per week over the preceding month - Consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day - Participation in another trial having received study medication within 1 month before the screening visit - Body Mass Index ≥ 33 - Use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, St. John's Wort, Alluna or prescription sleep medication - Use of any substance with psychotropic effects or properties know to affect sleep/wake - History of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia - Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder - Positive qualitative urine drug screen (opiates, cocaine, amphetamine…) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. | |
| 8 | NCT00727857 | completed | 1 | phase 3 | ['diabetes mellitus'] | ["['P70.2', 'O24.92', 'Z83.3', 'E10.65', 'E10.9', 'E11.65', 'E11.9']"] | ['pioglitazone and metformin', 'pioglitazone', 'metformin'] | ['CCC1=CN=C(C=C1)CCOC2=CC=C(C=C2)CC3C(=O)NC(=O)S3', 'CN(C)C(=N)N=C(N)N'] | Inclusion Criteria - Has type 2 diabetes. - Has received no treatment with antidiabetic medication in the 12 weeks prior to Screening, other than short-term use defined as less than or equal to 15 days. - A glycosylated hemoglobin greater than or equal to 7.5% and less than or equal to 10.0% at Screening. - Body mass index less than or equal to 45 kg/m2. - Has received counseling on lifestyle modification for type 2 diabetes, including diet and exercise. - Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. - Stable condition as determined by a physician. Exclusion Criteria - Type 1 diabetes. - Unstable angina or heart failure of any etiology with New York Heart Association functional class III or IV. - History of myocardial infarction, cerebrovascular accident, percutaneous coronary intervention, coronary artery bypass graft, or transient ischemic attack in the 6 months prior to Screening. - Male participant has a serum creatinine level greater than or equal to 1.5 mg per dL or female subject has a serum creatinine level greater than or equal to 1.4 mg per dL. - Has a triglyceride level greater than 500 mg per dL. - Male participant has a hemoglobin level less than 10.5 g per dL or female subject has a hemoglobin level less than 10.0 g per dL. - Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice. - History of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic drinks per day) within 2 years prior to Screening. - Has been discontinued from a thiazolidinedione or metformin therapy due to lack of efficacy or clinical or laboratory signs of intolerance. - Previous history of cancer, other than basal cell or stage 1 squamous cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication. - History of acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma. - Any disease or condition at Screening or Randomization that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol. - Currently participating in another investigational study or has participated in an investigational study within 30 days prior to randomization. - Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including: - Antidiabetic medications other than study medication - Chronically used oral or parenteral glucocorticoids - Niacin greater than 200 mg per day, including niacin-containing products such as Advicor - Chronically used steroid-joint injections | |
| 9 | NCT00657137 | terminated | slow accrual | 0 | phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['apricoxib + lapatinib + capecitabine', 'placebo + lapatinib + capecitabine'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - Females with pathologically determined locally advanced or metastatic human epidermal growth factor receptor 2 positive (HER2/neu+) breast cancer - Have progressed after treatment with chemotherapy including a taxane and trastuzumab - Must have measurable disease by RECIST - ECOG PS of 0,1, or 2 - MUGA scan or echocardiogram results show left ventricular ejection fraction greater than or equal to 50% Exclusion Criteria: - Radiation therapy within 2 weeks, chemotherapy within 3 weeks, or noncytoxic investigational agents within 4 weeks of initiating study treatment - Evidence of New York Heart Association class III or greater cardiac disease - History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality - History of congenital QT prolongation - Concurrent severe or uncontrolled medical disease - Symptomatic central nervous system metastases - Pregnant or nursing women - Hypersensitivity or intolerance to apricoxib, lapatinib, capecitabine, 5-FU, sulfonamides, aspirin, or NSAIDs - Severe renal insufficiency - History of upper GI bleeding, ulceration, or perforation- Concurrent use of potent CYP3A4 inhibitors and CYP3A4 inducers - Prior treatment with capecitabine - Patients on anti-arrhythmic treatment - Prior lapatinib therapy |
| 10 | NCT00312052 | completed | 0 | phase 2 | ['coronary artery disease'] | ["['I25.10', 'I25.110', 'I25.112', 'I25.119', 'I25.111', 'I25.118']"] | ['e5555', 'placebo'] | ['CCOC1=C(C(=C2C(=C1)CN(C2=N)CC(=O)C3=CC(=C(C(=C3)N4CCOCC4)OC)C(C)(C)C)F)OCC'] | INCLUSION CRITERIA: 1. Males or Females, 45 - 80 years of age 2. Confirmed coronary artery disease defined as one of the following: - Post-acute coronary syndrome or myocardial infarction or - Post percutaneous coronary intervention or coronary artery bypass graft or oAngina pectoris with documented (electrocardiogram or imaging study) ischemia or - Angiographically documented lesion occluding ≥70% of a coronary vessel And at high risk as defined as one or more of the following: - Elevated hsCRP (high-sensitivity C-reactive protein) - Diabetes mellitus - History of carotid artery disease and/or peripheral artery disease - Thrombo-embolic transient ischemic attack or stroke >1 year prior to screening 3. All subjects must be receiving low dose aspirin and/or clopidogrel and/or ticlopidine. EXCLUSION CRITERIA 1. History of acquired or congenital bleeding disorder, coagulopathy or platelet disorder, or history of pathological bleeding within the last 6 months 2. History of intracranial bleeding, history of hemorrhagic retinopathy or known structural cerebral vascular lesion 3. Clinically significant hematological, hepatic or renal abnormalities 4. Patients with some specific ST-segment changes, severe congestive heart failure or uncontrolled cardiac arrhythmias at baseline 5. Recent significant (as determined by the investigator) cardiovascular events | |
| 11 | NCT00227370 | completed | 1 | phase 3 | ['cytomegalovirus infections'] | ["['P35.1']"] | ['valganciclovir'] | ['Status: 503'] | Inclusion Criteria for Phase I: - Adult lung transplant recipients age 18 or older - At risk for CMV (donor or recipient serology must be positive for CMV) - Adequate hematological and renal function, - On intravenous (IV) ganciclovir within 24 hours of surgery - Agreement to use effective methods of contraception - Negative pregnancy - Tolerate oral medications within 2 weeks of transplant - Negative baseline CMV PCR - Able to understand and sign the informed consent Exclusion Criteria for Phase 1: - Repeat transplantation - Mechanical ventilation at study entry - Oral or intravenous ganciclovir treatment outside the study protocol - Invasive fungal infection - Participation in another investigational study - Acute CMV infection or disease - Anti-CMV therapy within 30 days before enrollment - Uncontrolled diarrhea or malabsorption - Allergic reaction to study drug - Required use of prohibited medications - Lactating women - Pregnancy - Renal failure Inclusion Criteria for Phase II: - Negative serial post transplant PCRs at day 75 - Negative bronchial cultures for CMV - Adequate hematological and renal function at day 75 - IV ganciclovir for up to 2 weeks post operation and open label up to day 90 - Effective contraceptives - Negative pregnancy Exclusion Criteria Phase II: - Renal failure - Serious adverse events (SAE) related to study drug - CMV disease (study endpoint) - Withdraw consent for Phase II | |
| 12 | NCT00006374 | withdrawn | slow accrual | 0 | phase 2 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['cisplatin', 'etoposide', 'paclitaxel', 'topotecan hydrochloride'] | ['Status: 503', 'Status: 503', 'Status: 503', 'Status: 503'] | DISEASE CHARACTERISTICS: Diagnosis of extensive stage small cell lung cancer At least 1 bidimensionally measurable non CNS lesion At least 1 cm in one diameter and at least 2 cm in another diameter by CT or MRI scan At least 2 cm in two diameters by x-ray, ultrasound, or for palpable tumor masses by physical exam Measurable skin lesion at least 1 cm in at least one diameter by photography No symptomatic CNS and/or leptomeningeal metastases requiring corticosteroid therapy to control symptoms PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,500/mm3 Hemoglobin at least 9.0 g/dL Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT, SGPT, and alkaline phosphatase no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No preexisting cardiac disease No congestive heart failure No cardiac arrhythmia requiring therapy No myocardial infarction within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 3 months before, during, and for at least 4 weeks after study No active uncontrolled infection No other concurrent or prior malignancies within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I low grade prostate cancer No other severe medical problem or any other medical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 24 hours since prior radiotherapy if no marked bone marrow suppression expected At least 6 weeks since prior radiotherapy to measurable lesion if evidence of progression Concurrent radiotherapy for bone pain control allowed Surgery: At least 3 weeks since prior surgery Other: At least 30 days or 5 half lives (whichever is longer) since prior investigational drug No other concurrent investigational drugs |
| 13 | NCT00378911 | completed | 0 | phase 2 | ['recurrent uterine sarcoma', 'uterine leiomyosarcoma'] | ["['G47.13', 'J01.41', 'K11.22', 'K12.0', 'N96', 'F33.8', 'G03.2']"] | ['sunitinib malate'] | ['CCN(CC)CCNC(=O)C1=C(NC(=C1C)C=C2C3=C(C=CC(=C3)F)NC2=O)C.C(C(C(=O)O)O)C(=O)O'] | Inclusion Criteria: - Histologically confirmed leiomyosarcoma of the uterus - Recurrent or persistent disease - Refractory to curative therapy or established treatments - Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan - Ascites and pleural effusions are not considered measurable disease - Must have ≥ 1 target lesion to assess response - Tumors in a previously irradiated field are considered non-target lesions unless there is documented progression or biopsy-confirmed persistence ≥ 90 days after completion of radiotherapy - Received at least 1 but no more than 2 prior cytotoxic regimens - Initial treatment may have included high-dose chemotherapy, consolidation, or extended therapy administered after surgery or nonsurgical assessment - Cytotoxic regimens may have included any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa - Not a candidate for a higher priority GOG protocol - No known brain metastases - GOG performance status 0-2 (for patients who have received 1 prior regimen) OR GOG 0-1 (for patients who have received 2 prior regimens) - Absolute neutrophil count ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Hemoglobin ≥ 9 g/dL - Creatinine ≤ 1.5 times upper limit of normal (ULN) - Bilirubin ≤ 1.5 times ULN - SGOT ≤ 2.5 times ULN - Alkaline phosphatase ≤ 1.5 times ULN - QTc < 500 msec - LVEF normal by echocardiogram - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment - Patients with a pre-existing thyroid abnormality unable to maintain normal thyroid function with medication are not eligible - No significant EKG abnormalities (i.e., no history of serious ventricular arrhythmia OR EKG with ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) - No sensory or motor neuropathy > grade 1 - No NYHA class III-IV congestive heart failure - NYHA class II cardiac dysfunction allowed - History of NYHA class II heart failure that is asymptomatic on treatment allowed - No active infection requiring antibiotics - No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate - No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg) - No gastrointestinal tract disease resulting in an inability to take oral medication - No requirement for IV alimentation - No active peptic ulcer disease - No other condition that would impair ability to swallow and retain study drug - No serious or nonhealing wound, ulcer, or bone fracture - No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days - No cerebrovascular accident or transient ischemic attack within the past year - No myocardial infarction, cardiac arrhythmia, stable or unstable angina, or symptomatic congestive heart failure within the past year - No pulmonary embolism within the past year - No uncontrolled illness including, but not limited to, any of the following: - Ongoing or active infections - Psychiatric illness or social situations that would preclude study compliance - Recovered from prior surgery, chemotherapy, or radiotherapy - Prior anthracycline exposure and central thoracic radiation that included the heart allowed provided patient has New York Heart Association (NYHA) class II cardiac function - At least 1 week since prior hormonal therapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) or radiotherapy - At least 4 weeks since prior major surgery - At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin and no recurrent or metastatic disease - At least 3 years since prior adjuvant chemotherapy for localized cancer of the breast and no recurrent or metastatic disease - No prior radiotherapy to any portion of the abdominal cavity or pelvis unless for treatment of leiomyosarcoma - No prior chemotherapy to any portion of the abdominal cavity or pelvis unless for treatment of leiomyosarcoma - No prior noncytotoxic chemotherapy for recurrent or persistent disease - No prior surgical procedures affecting absorption - No coronary or peripheral artery bypass graft or stenting within the past year - No other prior antiangiogenic agents (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, vatalanib, or vascular endothelial growth factor [VEGF] Trap) - No other prior cancer treatment that would preclude study treatment - At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following: - Azole fungals (e.g., ketoconazole or itraconazole) - Clarithromycin - Erythromycin - Diltiazem - Verapamil - HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or nelfinavir) - Delavirdine - At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following: - Rifampin - Rifabutin - Carbamazepine - Phenobarbital - Phenytoin - Hypericum perforatum (St. John's wort) - Efavirenz - Tipranavir - No concurrent proarrhythmic potential agent, including any of the following: - Terfenadine - Quinidine - Procainamide - Disopyramide - Sotalol - Probucol - Bepridil - Haloperidol - Risperidone - Indapamide - Flecainide - No concurrent therapeutic coumarin-derivative anticoagulants, such as warfarin - Doses ≤ 2 mg daily allowed for prophylaxis of thrombosis - Low molecular weight heparin allowed provided PT INR ≤ 1.5 - No concurrent amifostine or other protective agents - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational agents - No other concurrent anticancer agents or therapies | |
| 14 | NCT00075764 | completed | 1 | phase 3 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['anastrozole', 'fulvestrant'] | ['CC(C)(C#N)C1=CC(=CC(=C1)CN2C=NC=N2)C(C)(C)C#N', 'Status: 503'] | DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer meeting 1 of the following criteria: - Metastatic disease (M1) - Multiple sites of new disease that is clinically obvious metastatic disease (e.g., multiple sites of new osseous disease) - Measurable or nonmeasurable disease - No known brain or CNS metastases - Hormone receptor status: - Estrogen-receptor positive* AND/OR - Progesterone-receptor positive* NOTE: *Positivity defined as estrogen binding of > 10 fmol/mg cytosol protein by ligand binding assay or positive by immunohistochemistry PATIENT CHARACTERISTICS: Age - Not specified Sex - Female Menopausal status - Postmenopausal, as defined by 1 of the following: - Prior bilateral oophorectomy - More than 12 months since last menstrual period with no prior hysterectomy - At least 55 years of age with prior hysterectomy - Under 55 years of age with a prior hysterectomy without oophorectomy and with estradiol and follicle-stimulating hormone levels consistent with menopause Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - No bleeding diathesis (e.g., disseminated intravascular coagulation or clotting factor deficiency) Hepatic - INR ≤ 1.6 Renal - Not specified Other - HIV negative - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy - No prior immunotherapy for recurrent or metastatic disease Chemotherapy - No prior chemotherapy for recurrent or metastatic disease - More than 12 months since prior adjuvant or neoadjuvant chemotherapy - No concurrent chemotherapy for malignancy Endocrine therapy - Prior adjuvant hormonal therapy allowed - At least 12 months since prior adjuvant luteinizing hormone-releasing hormone (LHRH) analogues - Menstrual periods must not have resumed since LHRH therapy - More than 12 months since prior adjuvant or neoadjuvant aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane) - More than 12 months since prior fulvestrant - No prior hormonal therapy for recurrent or metastatic disease - No other concurrent hormonal therapy for malignancy - No concurrent hormone replacement therapy Radiotherapy - Not specified Surgery - Not specified Other - No long-term anticoagulant therapy (except antiplatelet therapy) | |
| 15 | NCT01529541 | completed | 1 | phase 3 | ['type 2 diabetes mellitus'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['anagliptin', 'sitagliptin'] | ['CC1=NN2C=C(C=NC2=C1)C(=O)NCC(C)(C)NCC(=O)N3CCCC3C#N', 'C1CN2C(=NN=C2C(F)(F)F)CN1C(=O)CC(CC3=CC(=C(C=C3F)F)F)N'] | Inclusion Criteria: - Patients who had diagnosed with type 2 DM before 3 months - Men and women between the age of ≥ 19 and ≤ 75 years - FPG ≤ 270 mg/dL at screening visit - Patients who consent to participate in this trial by written Informed Consent Form Exclusion Criteria: - Type 1 DM or secondary diabetes - Subjects who are administrating oral anti-hyperglycemic drugs or have to take a medicine - Body mass index < 20 kg/m2 or > 40.0kg/m2 - Subjects who are assessed to be inappropriate for this trial by investigator | |
| 16 | NCT00516542 | terminated | study was terminated due to lack of accrual | 0 | phase 1 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['letrozole', 'dhea'] | ['Status: 503', 'Status: 503'] | DISEASE CHARACTERISTICS: - Diagnosis of breast cancer - Metastatic disease - Hormone receptor status - Estrogen receptor- and progesterone receptor-negative - Androgen receptor-positive PATIENT CHARACTERISTICS: - ECOG performance status 0-3 - Postmenopausal (> 60 years of age) - Leukocyte count > 3,000/uL - Absolute neutrophil count > 1,500/uL - Platelet count > 100,000/uL - Total bilirubin normal - AST and ALT < 2.5 times upper limit of normal - Creatinine normal OR creatinine clearance > 60 mL/min PRIOR CONCURRENT THERAPY: - At least 4 weeks since prior chemotherapy - At least 4 weeks since prior biologic therapy - At least 4 weeks since prior radiotherapy - At least 30 days since prior investigational agents - No concurrent dehydroepiandrosterone or androstenedione supplements - No concurrent chemotherapy or radiotherapy - No concurrent hormone therapy or immunotherapy (including trastuzumab [Herceptin®]) |
| 17 | NCT00420420 | completed | 0 | phase 2 | ["alzheimer's disease"] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['mk0249', 'comparator: placebo (unspecified)'] | ['CC1=NC2=CC=CC(=C2C(=O)N1C3=CC=C(C=C3)OCCCN4CCCC4)C(F)(F)F'] | Inclusion Criteria: - Male or females - Age at least 55 years or older - Mild-to-moderate Alzheimer's Disease, with Mini Mental State Examination (MMSE) between 18 and 26, inclusive, Modified Hachinski Ischemic Scale (MHIS) score =/<4, Global CDR score of 1 or 2, and who have a reliable informant/caregiver to accompany patient to all clinic visits - If using symptomatic Alzheimer's Disease treatments, patients must be on the medication for 3 months and on a STABLE DOSE for at least 2 months Exclusion Criteria: - Patients cannot be living in a skilled nursing facility - Patients cannot have poorly-controlled hypertension - Patients cannot have the following conditions within 6 months of screening: significant cardiovascular disorders, active major depressive disorder, gastroesophageal reflux disease (GERD), or clinically significant sleep disorder - Various concomitant therapy restrictions | |
| 18 | NCT00588900 | terminated | 0 | phase 2 | ['colorectal cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['cediranib maleate', 'irinotecan hydrochloride'] | ['CC1=CC2=C(N1)C=CC(=C2F)OC3=NC=NC4=CC(=C(C=C43)OC)OCCCN5CCCC5.C(=CC(=O)O)C(=O)O', 'Status: 503'] | DISEASE CHARACTERISTICS: - Histologically or cytologically documented metastatic colorectal cancer - The site of the primary lesion must be or have been confirmed endoscopically, surgically, or radiologically to have been in the colon or rectum - Patients with a history of histologically proven colorectal cancer treated by surgical resection and who develop radiological or clinical evidence of metastatic cancer do not require additional histological or cytological confirmation of metastatic disease unless either of the following are true: - An interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease - The primary cancer was stage I - Must have measurable disease, defined as in at least one dimension (longest dimension to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan - Lesions that are considered nonmeasurable include the following: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Lymphangitis cutis/pulmonis - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - Must have received one and only one prior regimen for metastatic disease containing oxaliplatin, a fluoropyrimidine, and bevacizumab - Patients who discontinue oxaliplatin due to toxicity are eligible provided they progressed on the fluoropyrimidine component with or without bevacizumab - No known brain metastases PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - ANC ≥ 1,500/μL - Platelet count ≥ 100,000/μL - Hemoglobin ≥ 8 g/dL - Leukocytes ≥ 3,000/mm³ - Calculated creatinine clearance > 50 mL/min - ALT/AST ≤ 2.5 times upper limit of normal (ULN) - Urine protein < 1+ protein OR protein < 1g by 24-hour urine collection and urine protein:creatinine ratio < 1.0 - Total bilirubin normal - Not pregnant or nursing - Negative pregnancy test - No known end-stage liver disease or active hepatitis - No colonic or small bowel disorders (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis) that predispose to diarrhea in which the symptoms are uncontrolled as indicated by baseline pattern of > 3 watery or soft stools daily in patients without a colostomy or ileostomy - Patients with a colostomy or ileostomy may be entered at investigator discretion - History of hypertension allowed provided it is well controlled (BP < 150/90 mm Hg) on a regimen of antihypertensive therapy - No concurrent congestive heart failure (New York Heart Association class III or IV) - No significant history of bleeding events or gastrointestinal (GI) perforation - Patients with a history of significant bleeding episodes (e.g., hemoptysis, upper or lower GI bleeding) within 3 months prior to beginning treatment are not eligible unless the source of bleeding has been surgically resected - Patients with a history of GI perforation within 12 months prior to beginning treatment are not eligible - No arterial thrombotic events within 6 months before beginning treatment, including any of the following: - Transient ischemic attack - Cerebrovascular accident - Unstable angina or angina requiring surgical or medical intervention within the past 6 months - Myocardial infarction - No serious or nonhealing wound, ulcer, or bone fracture - Patients with clinically significant peripheral artery disease (i.e., claudication on ambulating less than one block) or any other arterial thrombotic event within 6 months are also ineligible - QTc interval ≤ 470 msec - No personal or family history of long QT syndrome. PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Must have recovered from all acute toxicities of prior therapy for metastatic disease except peripheral neuropathy - At least 6 weeks between the last dose of bevacizumab and the first dose of cediranib - Prior pelvic irradiation is allowed (as long as the measurable lesion is outside the radiotherapy field) - Completed any major surgery ≥ 4 weeks from start of treatment and completed any minor surgery ≥ 1 week prior to start of treatment - Insertion of a vascular access device is not considered major or minor surgery from the standpoint of protocol eligibility - Patients must have fully recovered from the procedure and have a fully healed incision - Patients on full-dose anticoagulation (e.g., warfarin) are eligible provided that both of the following criteria are met: - The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or is on a stable dose of low molecular weight heparin - The patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices) - Patients receiving anti-platelet agents are eligible - Patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible - The use of agents with strong proarrhythmic potential is not permitted during the study - Patients who received treatment on CALGB-C80405 and whose treatment failed are eligible for this study | |
| 19 | NCT01432457 | completed | 1 | phase 4 | ['major depressive disorder'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['desvenlafaxine succinate sustained-release 50 mg/day', 'desvenlafaxine succinate sustained-release 100 mg/day', 'placebo'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - Male or female outpatients aged 18 years or older who are fluent in written and spoken English. - A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features. - A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no more than a 4-point improvement from screening to baseline. Exclusion Criteria: - Significant risk of suicide based on clinical judgment. - Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder. - Current generalized anxiety disorder, panic disorder, or social anxiety disorder. - History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs. - Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results. | |
| 20 | NCT01063517 | completed | 0 | phase 2 | ['gastric cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['olaparib', 'paclitaxel', 'placebo'] | ['C1CC1C(=O)N2CCN(CC2)C(=O)C3=C(C=CC(=C3)CC4=NNC(=O)C5=CC=CC=C54)F', 'CC1=C2C(C(=O)C3(C(CC4C(C3C(C(C2(C)C)(CC1OC(=O)C(C(C5=CC=CC=C5)NC(=O)C6=CC=CC=C6)O)O)OC(=O)C7=CC=CC=C7)(CO4)OC(=O)C)O)C)OC(=O)C'] | Inclusion Criteria: - Recurrent or metastatic gastric cancer that has progressed following first line-therapy - Confirmed ATM protein status by IHC archival tumour sample - At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline and follow up visits Exclusion Criteria: - More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting - Any previous treatment with a PARP inhibitor, including olaparib - Patients with second primary cancer, except; adequately treated non melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for >5 years | |
| 21 | NCT00712322 | terminated | due to extremely difficult enrollment. | 0 | phase 2 | ['neurogenic detrusor overactivity'] | ["['R46.3', 'E27.0']"] | ['darifenacin'] | ['C1CN(CC1C(C2=CC=CC=C2)(C3=CC=CC=C3)C(=O)N)CCC4=CC5=C(C=C4)OCC5'] | Inclusion Criteria: - Male and female participants ages 2-15 years - Documented detrusor overactivity associated with a known neurological condition such as meningomyelocele or spinal cord injury, and confirmed by urodynamics at baseline - Using clean intermittent catheterization (CIC) on a regular basis - Participating in a bowel program on a regular basis - Able to swallow the study medication in accordance to the protocol - Participants and/or parent/guardian able to complete the bladder diary and follow the study procedures Exclusion Criteria: - Treatment with drugs known to significantly affect the urinary bladder and urinary bladder outlet function - Fecal impaction. Participants may be included, once this condition has resolved - Clinically significant anatomical abnormalities or acquired disorders of the urinary tract - Previous reconstructive surgery (augmentation etc.) of the bladder or bladder outlet - Symptomatic urinary tract infection unresolved at time of urodynamic study and/or completion of bladder diary. - Diabetes insipidus - Electro stimulation therapy or bladder training within 2 weeks prior to Visit 1 and at any time during the study - Concomitant diseases, in which the use of darifenacin is contraindicated - History of hypersensitivity to darifenacin or to drugs with similar chemical structures - Participants with any physical and cognitive impairment or any other condition which in the opinion of the investigator makes the participants unsuitable for inclusion - Female adolescent of child-bearing potential, unless using an acceptable method of contraception - Pregnant or nursing (lactating) female adolescents Other protocol-defined inclusion/exclusion criteria may apply. |
| 22 | NCT01405560 | completed | 1 | phase 3 | ['hepatitis c, chronic'] | ["['B18.2', 'B18.0', 'B18.1', 'B18.8', 'B18.9', 'K71.3', 'K71.4']"] | ['vaniprevir', 'ribavirin'] | ['CCC1CC1(C(=O)NS(=O)(=O)C2CC2)NC(=O)C3CC4CN3C(=O)C(NC(=O)OCC(CCCCC5=C6CN(CC6=CC=C5)C(=O)O4)(C)C)C(C)(C)C', 'C1=NC(=NN1C2C(C(C(O2)CO)O)O)C(=O)N'] | Inclusion criteria: - Japanese participant diagnosed with compensated CHC GT 1 - Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease - Has received and tolerated treatment with IFN-based therapy (IFN α, IFN β, or peg-IFN) with or without use of ribavirin, but failed to respond to the prior treatment (partial responder or null responder) - No evidence of cirrhosis Exclusion criteria: - Co-infection with human immunodeficiency virus (HIV) - Positive hepatitis B surface antigen or other evidence of active hepatitis B infection - Any other condition that is contraindicated or for which caution is required for treatment with peg-IFN or RBV - Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-IFN and RBV, to the participant | |
| 23 | NCT01655849 | completed | 0 | phase 2 | ['lumbosacral radiculopathy'] | ["['M54.17', 'M47.27', 'M47.817', 'M51.17']"] | ['z160', 'placebo'] | ['C1CN(CCN1C(C2=CC=CC=C2)C3=CC=CC=C3)C(=O)CC(C4=CC=CC=C4)C5=CC=CC=C5'] | Inclusion Criteria: 1. The subject must have a diagnosis of pain due to LSR, with all of the following characteristics: - The subject perceives pain in one or both lower limbs at sites that are consistent with the area innervated by the L4, L5, or S1 nerve roots, with or without other sensory symptoms in the affected areas (typically, the pain may be perceived in the buttock, thigh, calf, leg, foot, or toes). - The history of the pain suggests that the cause of the LSR is due to injury of the lumbosacral nerve root(s) by degenerative disease of the vertebrae in the lumbosacral spine or associated soft tissues (including the intervertebral discs). - The duration of pain since onset is ≥ 12 weeks. - Based on clinical history, the intensity of pain has been stable during the 2-week period before screening. 2. In the investigator's opinion, the subject's diagnosis of LSR is supported by all of the following at screening: - Based on the StEP instrument: - Neurological examination of lower limbs shows impaired muscle power, sensory function, or deep tendon reflexes in the territory of the affected nerve roots. - Pain/sensory disturbance in dermatomal/myotomal distribution is precipitated or exacerbated by straight leg raising (the straight-leg-raising test should be performed as specified in StEP). - The total StEP score is ≥ 4 (indicative of LSR as the cause of the pain) 4. At screening, the subject has an average daily pain score for neuropathic pain due to LSR of ≥ 3 and ≤ 8 on the PI-NRS. 5. If female, the subject must be postmenopausal (defined as no menstruation for at least 12 months), surgically sterilized for ≥3 months before the screening visit, or agree to use 2 reliable methods of contraception (oral, implantable, transdermal, or injectable contraceptives in conjunction with an intrauterine device or a barrier method) during the 6-week treatment period, during the 6 week posttreatment follow-up period, and for an additional 8 weeks after the last study visit (Week 12, Visit 9) to avoid pregnancy if of childbearing potential (defined as biologically capable of becoming pregnant). If male, the subject must agree to use condoms during the 6-week treatment period with the study drug, during the 6-week posttreatment follow up period, and for an additional 8 weeks after the last study visit (Week 12, Visit 9). Exclusion Criteria: 1. The subject has: - Neuropathic pain due to causes other than that specified in the inclusion criteria (e.g., postherpetic neuralgia; painful diabetic neuropathy; mononeuritis multiplex; central poststroke pain; failed back surgery in relation to the presenting episode of radiculopathy; spinal abscess, infection, hematoma, or malignancy; phantom limb pain; peripheral neuropathy due to alcoholism, malignancy, human immunodeficiency virus [HIV], syphilis; drug abuse; vitamin B12 deficiency; hypothyroidism; liver disease; toxic exposure). - Pain that is associated with a substantial somatic pain component (e.g., non-neuropathic/musculoskeletal pain in lower limbs or other parts of the body apart from the back) or more than one cause or potential cause for pain symptoms. - Any painful concurrent rheumatic disease such as, but not limited to, fibromyalgia, rheumatoid arthritis, or significant osteoarthritis. Any question regarding the acceptability of the etiology of the neuropathic pain should be discussed with the Zalicus medical monitor. 2. In the investigator's opinion, the subject is unable to reliably delineate or assess his or her own pain by anatomical location/distribution (e.g., the subject cannot reliably tell the difference between his or her back pain and lower limb pain and cannot rate the intensity of each separately). 3. The subject has pain in the lower limbs solely upon walking and not at rest. 4. The subject has undergone surgery for LSR within the last 6 months or has received treatment with epidural injections, nerve blocks, or acupuncture for LSR within 4 weeks before screening. 5. The subject has: - A history of seizure, excluding pediatric febrile seizures, or currently has seizures - A history of or a current diagnosis of schizophrenia or bipolar disorder - Had a stroke or TIA ≤ 6 months before the screening visit - Has an episode of major depression or generalized anxiety disorder ≤ 6 months before the screening visit. 6. The subject has a history of or currently has any of the following conditions that, in the investigator's opinion, may interfere with the study procedures or compromise the subject's safety: - Cardiovascular disease - Gastrointestinal disease - Hepatic disease - Respiratory disease - Renal disease - Any condition that is known to interfere with the absorption, distribution, metabolism, or excretion of drugs 7. The subject has a history of or currently has: - Any clinically significant vital sign, ECG, or laboratory abnormalities. - QTcF >450 msec (males) or >470 msec (females) 8. The subject had a malignancy. 9. The subject has had a positive test for HIV antibody or a history of HIV. 10. The subject has had a positive test for hepatitis B surface antigen or hepatitis C antibody. 11. The subject has a history of AST, ALT or bilirubine >2 times the upper limit of normal. 12. The subject has a history of hypersensitivity to calcium channel blockers. 13. The subject has a history of multiple drug allergies (≥ 2 kinds) that, in the investigator's opinion, may place him or her at greater risk during participation in the study. 14. The subject has participated in a previous clinical study of Z160 or has received another investigational drug ≤ 30 days before the screening visit. 15. The subject has taken a prohibited medication ≤ 30 days before the screening visit. 16. The subject has a history of alcohol or narcotic substance abuse, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), ≤ 1 year before the screening visit. 17. The subject has a positive urine drug test at screening. 18. The subject is female and is pregnant or breastfeeding at the time of the screening visit or plans to become pregnant during the study period. | |
| 24 | NCT00126659 | terminated | 0 | phase 2 | ['clear cell renal cell carcinoma', 'recurrent renal cell cancer', 'stage iv renal cell cancer'] | ["['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']", "['C96.20', 'C96.29', 'D47.09']", "['C96.20', 'C96.29', 'D47.09']"] | ['sorafenib tosylate'] | ['CC1=CC=C(C=C1)S(=O)(=O)O.CNC(=O)C1=NC=CC(=C1)OC2=CC=C(C=C2)NC(=O)NC3=CC(=C(C=C3)Cl)C(F)(F)F'] | Inclusion Criteria: - Patients with histologically or cytologically confirmed metastatic clear cell RCC who are eligible for cytoreductive nephrectomy as agreed upon by Medical Oncology and Urology team members; patients with metastatic disease eligible for cytoreductive nephrectomy should have the following characteristics: resectable primary tumor (no gross adjacent organ invasion, no or minimal abdominal lymphadenopathy, no or minimal inferior vena caval involvement), bulk of metastatic disease within the primary tumor, absence of multiple liver metastases, no more than 2 organ sites involved with metastases - Patients must have measurable disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures >= 20 mm with conventional techniques or >= 10 mm with spiral computed tomography (CT) scan - ECOG performance status =< 1 - Absolute neutrophil count >= 1,500/uL - Platelets >= 100,000/uL - Hgb > 9.0 g/dL - Total bilirubin =< 2.0 mg/dl - Albumin > 3.0 g/dL - Serum creatinine =< 2.0 mg/dl - AST (SGOT) and/or ALT (SGPT) =< 2.5 x institutional upper limit of normal for subjects without evidence of liver metastases - AST (SGOT) and/or ALT (SGPT) =< 5 X institutional upper limit of normal for subjects with documented liver metastases - Female patients of childbearing potential must have a normal plasma beta human chorionic gonadotropin (beta-HCG) within 24 hours prior to enrolling in the study due to the possible teratogenic effect; however, patients will be eligible if their beta-HCG is elevated and is determined to be due to malignancy - Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study - Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution; patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy - Patients must have ability to comply with study and/or follow-up procedures - Prior biopsy material (blocks or unstained slides) must be available for comparison purposes Exclusion Criteria: - No prior malignancy is allowed, except for non-melanoma skin cancer, in situ carcinoma of any site, or other cancers for which the patient has been adequately treated and disease free for 5 years - Patients must not have received any systemic anticancer therapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier - Patients must not be scheduled to receive another experimental drug while on this study; patients are permitted to be on concomitant bisphosphonates - Patients who are incapable of swallowing pills are excluded from this study - Patients must not have a primary brain tumor, any brain metastases, leptomeningeal disease, seizure disorders not controlled with standard medical therapy, or history of stroke - Patients must not have active acute infections that could be worsened by anticancer therapy or interfere with this study - Patients must not have clinically significant cardiovascular disease, recent myocardial infarction (i.e. last 6 months), (unstable angina), New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac dysrhythmia requiring medication, or peripheral vascular disease (grade II or greater) - Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications - Patients with uncontrolled hypertension > 140/90 are excluded from the study - Patients must not have any history of bleeding diathesis; patients must not be on therapeutic anticoagulation; prophylactic anticoagulation (i.e. low dose coumadin) of venous or arterial access devices is allowed provided that the requirements for PT, INR or PTT are met - Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with BAY 43-9006 - HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study | |
| 25 | NCT00132678 | completed | 1 | phase 3 | ['bipolar disorder'] | ["['F31.81', 'F31.89', 'F31.9', 'F25.0', 'F31.0', 'F31.31', 'F31.32']"] | ['risperdal consta', 'placebo'] | ['CC1=C(C(=O)N2CCCCC2=N1)CCN3CCC(CC3)C4=NOC5=C4C=CC(=C5)F'] | Inclusion Criteria: - Diagnosis of bipolar 1 disorder, currently experiencing a mixed or manic episode or stable - Two or more bipolar mood episodes in the last 2 years excluding current episode - Negative pregnancy test Exclusion Criteria: - History of > than 4 mood episodes a year during the last two years - patients experiencing a depressive episode - History of antisocial or borderline personality illness - Has unstable or serious general medical illness - Has received medications disallowed by study criteria. | |
| 26 | NCT00104624 | terminated | toxicity issues | 0 | phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['docetaxel'] | ['CC1=C2C(C(=O)C3(C(CC4C(C3C(C(C2(C)C)(CC1OC(=O)C(C(C5=CC=CC=C5)NC(=O)OC(C)(C)C)O)O)OC(=O)C6=CC=CC=C6)(CO4)OC(=O)C)O)C)O'] | DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the breast - Metastatic disease - Measurable disease by CT scan or MRI - Requires first-line chemotherapy for metastatic disease - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 70 and over Sex - Female Menopausal status - Not specified Performance status - Meets both of the following criteria: - Lawton's Instrumental Activities of Daily Living score ≥ 4 - Katz's Activities of Daily Living score ≥ 4 Life expectancy - More than 3 months Hematopoietic - Hemoglobin > 10 g/dL - Neutrophil count > 1,500/mm^3 - Platelet count > 100,000/mm^3 Hepatic - ALT and AST < 1.5 times normal - Bilirubin normal - Alkaline phosphatase < 2.5 times normal Renal - Creatinine clearance > 30 mL/min Cardiovascular - No congestive heart failure - No unstable angina pectoris - No myocardial infarction within the past year - No uncontrolled hypertension - No high-risk uncontrolled arrhythmias Other - Geriatric Depression Score < 12 - No active uncontrolled infection - No active peptic ulcer - No uncontrolled diabetes mellitus - No inflammatory bowel disease - No history of hypersensitivity to docetaxel or drugs formulated with polysorbate 80 - No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent - No familial, social, geographical, or psychological condition that would preclude study follow-up - No definite contraindication to corticosteroids - No other serious illness or medical condition - No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - No prior or concurrent trastuzumab (Herceptin^®) Chemotherapy - Prior neoadjuvant or adjuvant chemotherapy for breast cancer allowed - More than 2 years since prior docetaxel or paclitaxel - No other concurrent chemotherapy Endocrine therapy - No more than 1 prior hormonal therapy regimen for metastatic disease - At least 10 days since prior hormonal therapy - No concurrent hormonal therapy - No concurrent chronic corticosteroids - Concurrent low-dose corticosteroids (≤ 20 mg/day of methylprednisolone or equivalent) allowed provided treatment was initiated > 6 months before study entry Radiotherapy - Not specified Surgery - Not specified Other - More than 30 days since prior active treatment on another clinical trial - Concurrent bisphosphonates allowed for bone metastases, osteoporosis, or osteopenia - No other concurrent anticancer therapy - No other concurrent investigational drugs |
| 27 | NCT00521144 | completed | 0 | phase 1/phase 2 | ['recurrent small cell lung cancer', 'unspecified adult solid tumor, protocol specific'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['H01.009', 'H02.209', 'H02.009', 'H02.109', 'H04.209', 'H05.409', 'H10.509']"] | ['obatoclax mesylate', 'topotecan hydrochloride'] | ['CC1=CC(=C(N1)C=C2C(=CC(=C3C=C4C=CC=CC4=N3)N2)OC)C.CS(=O)(=O)O', 'CCC1(C2=C(COC1=O)C(=O)N3CC4=CC5=C(C=CC(=C5CN(C)C)O)N=C4C3=C2)O.Cl'] | Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of 1 of the following: - Advanced solid tumor (phase I) - Topotecan hydrochloride must be an appropriate treatment for this cancer - Small cell lung cancer (SCLC) (phase II) - Progressed after one prior platinum-based chemotherapy regimen - Pathology materials (tumor tissue) will be used for correlative studies, if available - No progressive brain metastases - Treated brain metastases allowed provided patient is neurologically stable and does not require steroids - No leptomeningeal involvement - ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100% - Leukocytes ≥ 3,000/mcL - Absolute neutrophil count ≥ 1,500/mcL - Platelet count ≥ 100,000/mcL - Total bilirubin normal - AST and ALT ≤ 2.5 times upper limit of normal - Creatinine normal OR creatinine clearance ≥ 60 mL/min - Not pregnant or nursing - Fertile patients must use effective double barrier method of contraception during and for 3 months after completion of study therapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered - At least 4 weeks since prior radiotherapy and recovered - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational agents or anticancer therapy Exclusion Criteria: - History of allergic reactions attributed to compounds of similar chemical or biological composition to obatoclax mesylate or topotecan hydrochloride (e.g., irinotecan) - Concurrent uncontrolled illness including, but not limited to, any of the following: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness or social situations that would limit compliance with study requirements - History of seizure disorder or other neurological dysfunction (except peripheral neuropathy) | |
| 28 | NCT00248482 | completed | 0 | phase 2 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['cisplatin', 'gleevec™', 'irinotecan'] | ['N.N.Cl[Pt]Cl', 'CCC1=C2CN3C(=CC4=C(C3=O)COC(=O)C4(CC)O)C2=NC5=C1C=C(C=C5)OC(=O)N6CCC(CC6)N7CCCCC7'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed small cell lung cancer (SCLC) - Extensive stage disease, defined by 1 of the following criteria: - Disease extends beyond one hemithorax and regional lymph nodes - Cytologically positive pleural effusion - Meets 1 of the following criteria: - Measurable disease, defined as ≥ 1 unidimensionally measurable lesion outside the field of any prior radiotherapy - Evaluable disease - No history of untreated or symptomatic brain or leptomeningeal metastases - Prior brain metastases allowed provided patient is neurologically stable for 2 weeks after completion of therapy PATIENT CHARACTERISTICS: Performance status - SWOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 8 g/dL Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - Meets 1 of the following criteria: - Alkaline phosphatase (AP) normal AND AST and ALT ≤ 2.5 times ULN - AP ≤ 5 times ULN AND AST and ALT normal - No acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis) Renal - Creatinine normal OR - Creatinine clearance ≥ 65 mL/min Cardiovascular - No uncontrolled congestive heart failure - No uncontrolled angina - No myocardial infarction and/or stroke within the past 3 months Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after completion of study treatment - No peripheral neuropathy ≥ grade 2 - No symptomatic edema from any etiology - No known HIV positivity - No other serious medical illness - No other malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix - No history of dementia, active psychiatric disorder, or other condition that would preclude study compliance or ability to take oral medication on a daily basis PRIOR CONCURRENT THERAPY: Chemotherapy - No prior chemotherapy for SCLC Endocrine therapy - No concurrent routine systemic corticosteroids Radiotherapy - See Disease Characteristics - At least 2 weeks since prior palliative radiotherapy Surgery - More than 2 weeks since prior major surgery Other - No concurrent therapeutic anticoagulation with warfarin - Concurrent low molecular weight heparin allowed provided regimen was initiated ≥ 2 weeks prior to study entry - No other concurrent participation in another study of an investigational agent | |
| 29 | NCT00678392 | completed | 1 | phase 3 | ['kidney neoplasms'] | ["['D17.71', 'D30.00', 'D30.01', 'D30.02', 'D41.00', 'D41.01', 'D41.02']"] | ['axitinib (ag-013736)', 'sorafenib'] | ['CNC(=O)C1=NC=CC(=C1)OC2=CC=C(C=C2)NC(=O)NC3=CC(=C(C=C3)Cl)C(F)(F)F'] | Inclusion Criteria: - Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis - Evidence of measurable disease - Must have failed one prior systemic first-line regimen for metastatic renal cell cancer Exclusion Criteria: - Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy - Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug | |
| 30 | NCT00321490 | completed | 1 | phase 3 | ['major depressive disorder'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['quetiapine fumarate', 'duloxetine'] | ['C1CN(CCN1CCOCCO)C2=NC3=CC=CC=C3SC4=CC=CC=C42.C1CN(CCN1CCOCCO)C2=NC3=CC=CC=C3SC4=CC=CC=C42.C(=CC(=O)O)C(=O)O', 'CNCCC(C1=CC=CS1)OC2=CC=CC3=CC=CC=C32'] | Inclusion Criteria: - Patient has a documented clinical diagnosis of Major Depressive Disorder. - Be able to understand and comply with the requirements of the study. - Able to understand and provide written informed consent Exclusion Criteria: - Patients (female) must not be pregnant or lactating - Current or past diagnosis of stroke or transient ischemic attack (TIA). | |
| 31 | NCT01218126 | completed | 0 | phase 2 | ['pulmonary disease, chronic obstructive'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['losmapimod', 'placebo'] | ['CC1=C(C=C(C=C1F)C(=O)NC2CC2)C3=NC=C(C=C3)C(=O)NCC(C)(C)C'] | Inclusion Criteria: - clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society - FEV1/FVC ratio of ≤0.70 - FEV1 ≤ 80% of predicted normal - 6MWD < 350m - male or female outpatients aged ≥40 years of age - current or prior history of ≥10 pack-years of cigarette smoking - aspartate transaminase (AST) or alanine transaminase (ALT) <2x Upper Limit Normal (ULN) - alkaline phosphatase (alk phos), and bilirubin <1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) - QTc <450 msec* on baseline ECG. For subjects with baseline complete bundle branch block, the QTc must be <480msec* on baseline ECG. Exclusion Criteria: - current diagnosis of asthma - pregnant or lactating - α1-antitrypsin deficiency - lung resection - chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD - exacerbation of COPD within previous 12 weeks - treatment with roflumilast within previous 2 weeks and throughout the treatment period - lower respiratory tract infection that required the use of antibiotics within previous 12 weeks - long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day - participation in the acute phase of a Pulmonary Rehabilitation Program within 12 weeks or planned during the study - carcinoma that has not been in complete remission for at least 5 years - current or chronic history of liver disease - positive Hepatitis B surface antigen or positive Hepatitis C antibody - Body Mass Index (BMI) > 35 - known or suspected history of alcohol or drug abuse within the last 2 years | |
| 32 | NCT00471718 | terminated | pharmaceutical company closed study because the treatment was not effective | 0 | phase 1/phase 2 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['abt-751'] | ['COC1=CC=C(C=C1)S(=O)(=O)NC2=C(N=CC=C2)NC3=CC=C(C=C3)O'] | Inclusion Criteria: - Patients at least 18 years of age. - Patients must have histologically proven adenocarcinoma of the prostate gland. - Patients must have metastatic disease (e.g. bone metastases, pelvic mass, nodal, liver or lung metastases), with evidence of radiographic progression (including bone scans observed during last treatment) or serologically -Patients with bone-only metastases (i.e. lacking soft tissue or visceral disease) must have a PSA level > 10 ng/mls. Patients with soft tissue metastases and/or visceral disease must have either measurable disease OR a PSA level > 10 ng/ml. - Patients must have had prior treatment with bilateral orchiectomy or other primary hormonal therapy (e.g. LHRH therapy, estrogens, etc.) with evidence of treatment failure and simultaneous documentation of a castrate testosterone level (< 50 ng/dL) NOTE: Patients who have not undergone bilateral orchiectomy must continue LHRH agonist therapy for the duration of this protocol unless this medically contraindicated. - For patients previously treated with flutamide, nilutamide, or bicalutamide: patients must have discontinued flutamide or nilutamide > 4 weeks prior to randomization (> 6 weeks for bicalutamide) with no evidence of an anti-androgen withdrawal response (i.e. no decline in serum PSA and/or no improvement in baseline scans). - Patients must have received prior therapy with docetaxel alone or in combination with either prednisone or estramustine. This therapy may have been given in a neoadjuvant, adjuvant or metastatic setting - Patients must not have received radiotherapy < 3 weeks prior to randomization. If patients have received prior radiotherapy to an evaluable lesion(s), there must be evidence of radiographic progression prior to entry. - Patients must not have received prior Strontium 89, Samarium 153, or other therapeutic radioisotopes. - Patients must have recovered from all systemic toxicities due to prior treatment for prostate cancer (does not include incontinence, impotence, etc. secondary to primary therapy) - The patient must have an ECOG Performance Status of 0-1 - The patient must have adequate hematologic, renal and hepatic function as follows: 1. Hematologic: ANC > 1200/mm3; hemoglobin > 9.0 g/dl; platelets > 100,000/mm3 2. Renal: serum creatinine < 2.0 mg/dL 3. Hepatic: bilirubin < 2.5 mg/dL; AST and ALT < 2.5X upper limit of normal (ULN); < 5X ULN for patients with hepatic metastases - Sexually-active patients must use a contraceptive method deemed acceptable by the investigator while in the study and for up to 3 months following completion of therapy. - The patient or the patient's legally acceptable representative has voluntarily signed and dated an informed consent approved by and Institutional Review Board prior to any study any study specific procedures. - Patients may be receiving bisphosphonate therapy prior to randomization and continue while receiving protocol therapy, but must not begin treatment with bispohosphonates while receiving protocol therapy. Patients on bisphosphonates must have completed at least 4 weeks of bisphosphonate therapy prior to entry onto study. - Patients with a history of a prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for the specific malignancy. Exclusion Criteria: - No active angina pectoris, uncontrolled hypertension, or known heart disease of New York Heart Association Class III-IV. Patients must not have a history of myocardial infarction, congestive cardiac failure (New York Heart Association Class 3), or coronary angioplasty/stenting < 6 months prior to entry. - No carcinomatous meningitis or brain metastases. - Any investigational therapy within 4 weeks. - No serious concurrent medical illness or active infection, which, in the opinion of the investigator, would jeopardize the ability of the patient to receive the chemotherapy outlined in this protocol with reasonable safety. - Documented history of allergy to sulfa medications. - Current colchicines treatment - Greater than Grade 1 CTC neurology category findings (Appendix A). - Prior treatment with more than 1 prior chemotherapy regimen. |
| 33 | NCT00004039 | withdrawn | no patient accruals | 0 | phase 2 | ['lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['cyclophosphamide', 'doxorubicin hydrochloride', 'prednisone', 'vincristine sulfate'] | ['Status: 503', 'Status: 503', 'Status: 503', 'Status: 503'] | DISEASE CHARACTERISTICS: Histologically confirmed high risk (stage III or IV) indolent or intermediate (stage II to IV) B-cell lymphoma Small cleaved cell lymphoma Waldenstrom's macroglobulinemia Follicular small cleaved cell or mixed cell Follicular large cell Diffuse Immunoblastic High risk is defined as: Increased LDH OR Increased beta-2-microglobulin OR B symptoms OR Bulky disease of greater than 7 cm in diameter OR Extranodal disease other than blood or bone marrow involvement OR Mantle zone histology At least 1 lymph node or visceral lesion at least 2 cm in diameter PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No active infection or other medical condition this is lifethreatening Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: No prior therapy for lymphoma |
| 34 | NCT00266747 | completed | 1 | phase 3 | ['anxiety disorders'] | ["['F41.1', 'F41.9', 'F40.9', 'F43.22', 'F41.0', 'F93.0', 'F12.980']"] | ['sr58611a'] | ['CCOC(=O)COC1=CC2=C(CCC(C2)NCC(C3=CC(=CC=C3)Cl)O)C=C1.Cl'] | Inclusion Criteria: - Out-patients, 18 to 65 years of age. - Patients suffering from generalized anxiety disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) plus GAD Module. - With a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) ³ 20. - Having given voluntarily their written informed consent to participate in the study. - Able to comply with the protocol and follow written and verbal instructions. - For inclusion into Segment B of the study, patients must fulfill the following criteria: - All Segment A inclusion criteria. - Completion of a minimum of 3 and a maximum of 9 days of treatment in Segment A. - Not "placebo responders" (i.e., improvement £ 20 % on HAM-A total score between V1 and V2) Exclusion Criteria: - Patients with a diagnosis of Major Depressive Disorder as defined by DSM-IV-TR within 6 months of study entry. - Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or higher at screening or baseline visits. - Patients having a moderate to high current risk for suicide. - Patients with other current anxiety disorder assessed with the MINI: agoraphobia, social phobia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, acute stress disorder. - Patients with a lifetime history according to the MINI of: bipolar disorders, psychotic disorders, antisocial personality disorder. - Patients with severe or unstable concomitant medical conditions according to the Investigator's judgment. - Females who are pregnant or lactating. - Female patients of childbearing potential must use an effective method of birth control during the entire study period. - Patients with positive test for any illicit drug included in the urine drug screen. - Participation in a clinical trial of an experimental therapy within 3 months prior to screening | |
| 35 | NCT00114959 | terminated | poor enrollment | 0 | phase 2 | ['myeloid leukemia, chronic', 'myeloid leukemia, chronic, accelerated-phase', 'blast phase', 'myeloid leukemia, chronic, chronic-phase'] | ["['C92.11', 'C92.12', 'C92.21', 'C92.22', 'C92.10', 'C92.20']"] | ['homoharringtonine', 'imatinib mesylate'] | ['CC(C)(CCCC(CC(=O)OC)(C(=O)OC1C2C3=CC4=C(C=C3CCN5C2(CCC5)C=C1OC)OCO4)O)O', 'Status: 503'] | Inclusion Criteria: - Male or female patients 16 years or older - Philadelphia chromosome (Ph) positive chronic myelogenous leukemia (CML) in either chronic, accelerated or blast phase - Patients with chronic phase CML will be either refractory (failed to achieve hematologic or cytogenetic response) or resistant (responded initially but subsequently lost hematologic or cytogenetic response) to prior imatinib mesylate therapy. Failure to achieve cytogenetic response is defined as follows: no cytogenetic response after 3 months of therapy with imatinib mesylate, no major cytogenetic response at 12 months of therapy, loss of complete cytogenetic response documented twice, or loss of major cytogenetic response at least once. - Patients with accelerated or blast phase may be newly diagnosed and previously untreated or if previously treated with imatinib mesylate, will be refractory or resistant to this agent or have failed to achieve at least a complete hematologic or cytogenetic response to treatment, as previously defined. - Patients in accelerated phase will meet one or more of the following criteria: greater than or equal to 15% through less than 30% blasts in peripheral blood or bone marrow, greater than or equal to 30% blasts + promyelocytes in peripheral blood or bone marrow, greater than or equal to 20% basophils in peripheral blood, platelet count less than 100*10^9/L unrelated to therapy or clonal evolution. - CML in blast phase will be defined as greater than or equal to 30% blasts in the bone marrow or presence of extramedullary disease - Patients must have completed all previous anti-leukemic therapy for at least 2 weeks, except as noted, and have fully recovered from side effects of a previous therapy, unless disease progression necessitates early therapy. Patients may receive leukapheresis, hydroxyurea and anagrelide for up to 24 hours prior to start of study treatment. Patients receiving imatinib mesylate may continue to receive it uninterrupted, except for a 3-day window at treatment cycle 1. - Bilirubin less than or equal to 2 times the upper limit of normal (ULN); alanine aminotransferase (ALT) less than or equal to 3 times ULN; creatinine less than or equal to 1.5 times ULN - Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 - Be able to comply with the requirements of the entire study - Be able and willing to provide written informed consent prior to any study related procedure - Patients and their partners must use an effective contraceptive during the study dosing period. The following are considered effective contraceptives: oral contraceptive pill, condom, diaphragm plus spermicide, abstinence, patient or partner surgically sterile, patient or partner more than 2 years post-menopausal, or injectable or implantable agent/device. Exclusion Criteria: - New York Heart Association (NYHA) Class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension or congestive heart failure - Myocardial infarction in the previous 12 weeks - Other intercurrent illness which would preclude study conduct and assessment, including but not limited to another active malignancy, uncontrolled and active infection, positive human immunodeficiency virus (HIV) or human T-cell lymphotropic virus (HTLV) I/II status - Pregnant or lactating - Any medical or psychiatric condition which may compromise the ability to give written informed consent or to comply with the study protocol |
| 36 | NCT00657150 | completed | 1 | phase 3 | ['venous thromboembolism'] | ["['O88.22', 'O88.23', 'O88.211', 'O88.212', 'O88.213', 'O88.219']"] | ['enoxaparin', 'dabigatran etexilate'] | ['Status: 503', 'Status: 503'] | Inclusion criteria: - Patients scheduled to undergo primary, unilateral, elective total hip arthroplasty. - Male or female 18 years of age or older. - Patients giving written informed consent for study participation. Exclusion criteria: - Patients weighing less than 40 kg. - History of bleeding diathesis. - Patients who in the investigators judgement are perceived as having an excessive risk of bleeding, for example, constitutional or acquired coagulation disorders or because of anticipated need of quinidine, verapamil or other restricted medication during the treatment period (see Section 4.2.2). - Major surgery or trauma (e.g., hip fracture) within 3 months of enrolment. - Recent unstable cardiovascular disease (in the investigators opinion) such as uncontrolled hypertension, that is ongoing at the time of enrolment or history of myocardial infarction within 3 months of enrolment. - Any history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, Atriovenous (AV) malformation or aneurysm. - Ongoing treatment for Venous Thromboembolism (VTE). - Clinically relevant bleeding (gastrointestinal, pulmonary, intraocular or urogenital bleeding) within 6 months of enrolment. - Gastric or duodenal ulcer within one year of enrolment. - Liver disease expected to have any potential impact on survival (ie, hepatitis B or C, cirrhosis). This does not include Gilberts syndrome or hepatitis A with complete recovery. - Active liver disease or liver disease decreasing survival (e.g, acute hepatitis, chronic active hepatitis, cirrhosis) or Alanine Aminotransferase (ALT) >3 x ULN. - Known severe renal insufficiency (CrCl <30 ml/min). Note: CrCl should be calculated only if serum creatinine is elevated or renal insufficiency is suspected. See Appendix 10.1 for calculation. - Elevated creatinine that, in the investigators opinion, contraindicates venography. - Treatment with anticoagulants, clopidogrel, ticlopidine, abciximab, aspirin >162.5 mg/day or NSAID with t 1/2 >12 hours within 7 days prior to hip replacement surgery OR anticipated need while the patient is receiving study medication and prior to 24 hours after the last administration of any blinded study medication (COX-2 selective inhibitors are allowed). - Anticipated required use of intermittent pneumatic compression and electric stimulation of lower limb. - Pre-menopausal women (last menstruation within 1 year prior to signing informed consent) who: - Are pregnant. - Are nursing. - Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include intrauterine device; oral, implantable or injectable contraceptives and surgical sterility. - Known allergy to radio opaque contrast media. - History of thrombocytopenia, including heparin-induced thrombocytopenia, or a platelet count <100,000 cells/microliter at randomisation. - Allergy to heparins or dabigatran etexilate. - Active malignant disease or current cytostatic treatment. Patients should be disease free for at least 5 years. - Participation in a clinical trial within 30 days of randomisation. - Leg amputee. - Known alcohol or drug abuse which would interfere with completion of the study. - Contraindications to enoxaparin. - Previous participation in this study. | |
| 37 | NCT00464698 | completed | 1 | phase 4 | ['obsessive compulsive disorder'] | ["['F42.8', 'F42.9', 'F60.5']"] | ['duloxetine'] | ['CNCCC(C1=CC=CS1)OC2=CC=CC3=CC=CC=C32'] | Inclusion Criteria: - Diagnosis of OCD by DSM-IV - Age 18-65 - Y-BOCS greater than 20 - Written informed consent - Females of childbearing potential must have a negative serum or urinary beta-HCG test. Exclusion Criteria: - Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception. - Patients who, in the investigator's judgment, pose a serious suicidal or homicidal risk. - Serious or unstable medical illness including cardiovascular (including hypertension), hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease. Patients on anticoagulant therapy. - History of seizure disorder - Comorbid bipolar disorder, psychosis, organic mental disorder, or developmental disorder - If there is a history of substance abuse, patients in remission at least 6 months. - Currently being treated with behavioral therapy, specifically exposure and response prevention, for OCD. - Other medications for medical disorders that may interfere with duloxetine - Current major depression or prescribed an antidepressant for major depression within the past 12 months. We will assess depressive symptoms with the BDI throughout the course of the study in order to assess subsyndromal depressive symptoms and to assess for the emergence of depressive symptoms. - Taken other psychotropic medication within 2 weeks of beginning the study (4 weeks for fluoxetine). - More than 1 adequate trial (at least 10 weeks at maximally tolerated dose) with another SSRI in the past. - Known hypersensitivity to duloxetine or any of the inactive ingredients. - Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI drug during the study or within 5 days of discontinuation of study drug. - Patients with uncontrolled narrow-angle glaucoma. | |
| 38 | NCT00622700 | completed | 1 | phase 3 | ['multiple sclerosis'] | ["['G35', 'C81.18']"] | ['teriflunomide', 'placebo'] | ['CC(=C(C#N)C(=O)NC1=CC=C(C=C1)C(F)(F)F)O'] | Inclusion Criteria: - First acute or subacute, well-defined neurological event consistent with demyelination (that is, optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes) - Onset of MS symptoms occurring within 90 days of randomization - A screening MRI scan with 2 or more T2 lesions at least 3 millimeter (mm) in diameter that are characteristic of MS Exclusion Criteria: - Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease - Significantly impaired bone marrow function - Pregnancy or nursing - Alcohol or drug abuse - Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment - Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. | |
| 39 | NCT00367679 | completed | 0 | phase 2 | ['non-small cell lung cancer', 'lung cancer, non-small cell'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['pazopanib'] | ['CC1=C(C=C(C=C1)NC2=NC=CC(=N2)N(C)C3=CC4=NN(C(=C4C=C3)C)C)S(=O)(=O)N'] | Inclusion criteria: - Signed, written informed consent provided prior to performing any study-specific procedures or assessments. Subject must be willing to comply with treatment and follow-up. - Subjects ≥21 years of age with a life expectancy of ≥12 weeks - The time between initial diagnosis and the scheduled surgery date allows for the subject to receive a minimum of 2 weeks or a maximum of 6 weeks treatment with pazopanib. Note: At least 4 weeks must be available between the diagnostic biopsy and surgery to allow for 1) one-week delay following the diagnostic biopsy prior to first dose of study drug, 2) minimum of 2 weeks on study drug, and 3) minimum of 1 week wash out prior to surgery. - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. - Histologically- or cytologically-confirmed Stage IA, IB, IIA, or IIB (to T2) NSCLC according to the International Staging System [Mountain, 1997] and must be scheduled for surgical resection. - Disease must consist of only a single lesion and must be measurable according to high-resolution CT scan-assisted volumetric measurement [Yankelevitz, 2000, Armato, 2004]. In addition to the measurable single lesion, other small indeterminate nodules may also be present - No approved or investigational anti-cancer therapy concurrently or in the 6 months prior to start of study drug, including surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, hormone therapy, biologic therapy, or anti-angiogegneic therapy (e.g., inhibitors of VEGF or VEGFR). - Fresh tumor biopsy for apoptosis and relevant biomarker analyses must be obtained within 30 to 8 days of first dose of study drug and must be available for all subjects prior to start of pazopanib treatment. - System (Laboratory Values) - Hematologic:Absolute neutrophil count (ANC)(≥ 1.5 X 109/L), Hemoglobin (≥9 g/dL), Platelets(≥100 X 109/L) - Hepatic:Albumin (≥ 2.5 g/dL), Serum bilirubin(≤1.5 X upper limit of normal (ULN) unless due to Gilbert's syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (≤2.0 X ULN) Renal:Serum creatinine(≤1.5 mg/dL) OR Calculated creatinine clearance (≥30 mL/min), Urine Protein (Trace or +1 by dipstick urinalysis or <1.0 gram determined by 24-hour urine protein analysis.) - Ability to swallow and retain oral medication - A female is eligible to enter and participate in this study if she is of: - Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had: - A hysterectomy - A bilateral oophorectomy (ovariectomy) - A bilateral tubal ligation - Is post-menopausal: - Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for ≥1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40mIU/mL and an estradiol value <40pg/mL (<140pmol/L). - Subjects must discontinue HRT prior to study enrollment due to the potential for inhibition of cytochrome P450 enzymes that metabolize estrogens and progestins. For most forms of HRT, at least 2-4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT. If a female subject is determined not to be post-menopausal, they must use adequate contraception, as defined immediately below. - Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. GlaxoSmithKline (GSK)-acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow: - An intrauterine device with a documented failure rate of less than 1% per year - Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female - Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product - Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide) Note: Oral contraceptives are not reliable due to potential drug-drug interactions. - Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 15 days following the last dose of study drug. - A male with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study. - Subjects must complete all screening assessments as outlined in the protocol Exclusion criteria: - Active malignancy or any malignancy in the 6 months prior to first dose of study drug. - Concurrent disease or condition that would make the subject inappropriate for study participation including (1) any unresolved or unstable, serious toxicity from prior administration of another investigational drug, (2) any serious medical disorder that would interfere with the subject's safety, obtaining informed consent, or compliance with all study related procedures. - Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedures such as fine needle aspiration or core biopsy within 1 week prior to beginning therapy are also excluded. - History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis. Routine screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated. - History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. - History of hemoptysis - Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded - Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning therapy - Active or uncontrolled infection - Concurrent treatment with an investigational agent or participation in another clinical trial. - Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib - Has taken/received prohibited medications within specified timeframes. - Corrected QT interval (QTc) prolongation defined as QTc interval >480 msecs - History of any one of the following cardiac conditions within the past 6 months: cardia angioplasty or stenting, myocardial infarction,or unstable angina - History of cerebrovascular accident within the past 6 months - Has Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. - Poorly controlled hypertension (mean systolic blood pressure (SBP) of ≥140mmHg, or mean diastolic blood pressure (DBP) of ≥ 90mmHg. Note: Initiation or adjustment of anti-hypertensive medication(s) is permitted prior to study entry. The blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 5 minutes. The mean SBP/DBP values from both BP assessments must be < 140/90mmHg in order for a subject to be eligible for the study. - History of untreated deep venous thrombosis (DVT) within the past 6 months (e.g. calf vein thrombosis). - Presence of any non-healing wound, fracture, or ulcer, or the presence of symptomatic peripheral vascular disease. - Receiving therapeutic warfarin or heparin as a concurrent medication. Note: prophylactic low-dose warfarin (less than or equal to 2 mg daily) is permitted. - Evidence of bleeding diathesis or coagulopathy - Pregnant or lactating female | |
| 40 | NCT00867126 | terminated | low accrual | 0 | early phase 1 | ['pancreatic cancer'] | ["['C25.3']"] | ['pioglitazone hydrochloride'] | ['CCC1=CN=C(C=C1)CCOC2=CC=C(C=C2)CC3C(=O)NC(=O)S3.Cl'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the pancreas - Metastatic disease - Previously treated disease - Disease progression after first-line gemcitabine hydrochloride-based chemotherapy - Radiologically measurable disease PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - ANC ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9 g/dL - Serum creatinine < 1.5 times upper limit of normal (ULN) OR creatinine clearance > 45 mL/min - Total bilirubin ≤ 1.5 times ULN - AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after completion of study treatment - No NYHA class III-IV congestive heart failure - No unstable angina - No second malignancy except for localized nonmelanoma skin cancer - No psychiatric or addictive disorders that would preclude giving informed consent PRIOR CONCURRENT THERAPY: - Prior systemic therapy with fluorouracil, capecitabine, oxaliplatin, or erlotinib hydrochloride allowed - More than 12 months since prior and no other concurrent thiazolinediones - More than 6 months since prior treatment with immunosuppressive or immunomodulatory agents - No other concurrent anticancer therapy |
| 41 | NCT01715298 | completed | 1 | phase 3 | ['chronic obstructive pulmonary disease'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['nva237', 'placebo'] | ['C[N+]1(CCC(C1)OC(=O)C(C2CCCC2)(C3=CC=CC=C3)O)C.[Br-]'] | Inclusion criteria: 1. Patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with airflow obstruction of level 2 and 3 according to the current Global initiative for chronic Obstructive Lung Disease (GOLD) strategy (2011). 2. Patients with Forced Expiratory Volume in one second (FEV1) ≥ 30% and <80 % of the predicted normal, and FEV1/FVC < 0.70 when measured 45 min after the inhalation of 84 µg ipratropium bromide. 3. Current or ex-smokers with at least 10 cigarette pack years smoking history. Exclusion criteria: 1. Patients with a history of long QT syndrome, with a prolonged QTc measured during screening, or patients who have a clinically significant ECG abnormality at screening. 2. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 3. Pregnant or nursing (lactating) women. Women of childbearing potential unless using an effective method of contraception. 4. Patients who in the judgment of the investigator, would be at potential risk if enrolled into the study. 5. Patients who have a clinically significant concomitant disease at screening, including but not limited to clinically significant laboratory abnormalities, clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities, or with uncontrolled diabetes, which could interfere with the assessment of the efficacy and safety of the study treatment. 6. Patients with a body mass index (BMI) of more than 40 kg/m2. 7. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, or sympathomimetic amines. 8. Patients with any history of asthma, with onset of symptoms prior to age 40 years, or patients with a high blood eosinophil count during screening. Other protocol-defnied inclusion/exclusion criteria may apply. | |
| 42 | NCT00454662 | completed | 1 | phase 4 | ['hypertension', 'cardiovascular disease', 'diabetes'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']", "['A52.00', 'A52.09', 'A50.54', 'Z01.810', 'Q87.418', 'Z13.6', 'R94.30']", "['E23.2', 'N25.1', 'P70.2', 'O24.92', 'Z83.3', 'Z86.32', 'E10.65']"] | ['olmesartan medoxomil / amlodipine or azelnidipine', 'olmesartan medoxomil / low dose thiazide type drug'] | ['Status: 400', 'Status: 400'] | Inclusion Criteria: - Outpatients aged 65 years or older, and less than 85 years (at the time of informed consent), regardless of sex - Systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg in a sitting position on two consecutive measurements at clinic during use of 1 or more antihypertensive medications. - Systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg in a sitting position on two consecutive measurements at clinic without antihypertensive medication. - Require at least one of the following medical history or risk factors - Medical history - Cerebrovascular accident: cerebral infarction, brain hemorrhage, subarachnoid hemorrhage（6 months or more prior to registration） - Myocardial infarction, coronary revascularization (PCI or CABG) （6 months or more prior to registration） - Angina pectoris (except for the patients having history of hospitalization within 6 months prior to registration) - Risk factors - Male - Current diabetes mellitus, fasting glucose ≥ 110mg/dL or postprandial glucose ≥ 140mg/dl - Hypercholesterolemia (Total cholesterol ≥ 260mg/dL) - Low HDL cholesterolemia (HDL-C <40mg/dL) - Microalbuminuria (albumin/cr ≥ 30mg/gCr) or proteinuria (protein ≥ 1＋) - Left ventricular hypertrophy (ST-T change in the ECG and SV1＋RV5 ≥ 35mm, or left ventricular mass index: male ≥ 125 g/m2, female ≥ 110 g/m2) Exclusion Criteria: - Secondary hypertension or malignant hypertension - History of cerebrovascular accident (including TIA) or myocardial infarction within 6 months before registration - Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) done within 6 months before registration or scheduled - History of hospitalization for angina pectoris or heart failure within 6 months before registration - Severe heart failure (New York Heart Association [NYHA] functional class III or more severe) - Complications of atrial fibrillation, atrial flutter or severe arrhythmia - Severe hepatic or renal dysfunction (including current treatment of dialysis or renal dysfunction with serum creatinine ≥ 2.0mg/dL) - Not appropriate for change to the study drugs from current therapy for concurrent disease including coronary diseases (i.e. calcium channel blockers, diuretics, etc) - History of serious side effect from study drugs (AT1 subtype angiotensin II receptor antagonist, calcium channel blocker, diuretic) - Life threatening condition (malignant tumor, etc) - Not suited to be study subject judged by a study physician | |
| 43 | NCT00655135 | completed | 0 | phase 2 | ["crohn's disease"] | ["['K50.90', 'K50.913', 'K50.914', 'K50.911', 'K50.912', 'K50.918', 'K50.919']"] | ['ldp-02', 'placebo'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - Age 18 to 80, nonhospitalized, male or nonpregnant, nonlactating females voluntarily able to give informed consent. - Crohn's disease of at least 6 months' duration. - Endoscopic and/or histopathological and/or radiological documentation consistent with Crohn's disease obtained preferably within 24 months of screening. - Crohn's disease involving the colon and/or the ileum. - CDAI score from 220 to 400 (inclusive) at the time of the Screening visit. The CDAI must have remained between 220 and 400 after the 1-week Screening period for the patient to be eligible. - Patients may have been receiving oral or topical 5-ASA compounds provided the dosage had been stable for at least the 14-day period before the Screening visit. Patients were to be maintained on the 5-ASA compound at a constant dose at least through Day 57. Exclusion Criteria: - Patients with evidence of current GI infection (bacterial or parasitic) or significant infection within 45 days of the screening visit. - Patients with a serious underlying disease other than Crohn's disease including presence or history of malignancy (except basal cell carcinoma) and histological evidence of dysplasia. - Patients with significantly impaired liver or renal function. This includes those with established chronic liver disease including hepatitis B or C. - Patients with the laboratory abnormalities - Patients using ethanol or consuming illicit drugs which, in the investigator's opinion, may interfere with compliance with the study procedures. - Patients with active psychiatric problems which, in the investigator's opinion, may interfere with compliance with the study procedures. - Patients who have previously received or who are currently receiving treatment with a monoclonal antibody. - Patients receiving any investigational therapy, excluded medications as defined in protocol, or any approved therapy in an investigational protocol within 30 days prior to screening. - Patients unable to attend all the study visits or comply with study procedures. | |
| 44 | NCT00144521 | completed | 1 | phase 3 | ['rheumatoid arthritis'] | ["['M06.9', 'M05.9', 'M06.08', 'M06.00', 'M06.011', 'M06.012', 'M06.019']"] | ['mra(tocilizumab)', 'mra placebo', 'mtx', 'mtx placebo'] | ['CN(CC1=CN=C2C(=N1)C(=NC(=N2)N)N)C3=CC=C(C=C3)C(=O)NC(CCC(=O)O)C(=O)O'] | Inclusion criteria - Diagnosis of RA based on the 1987 classification criteria of the American College of Rheumatology (ACR) - Disease duration of 6 months or more - Treated with 8 mg/week of MTX for at least 8 weeks immediately preceding enrollment, and continued on this treatment up to initiation of the study drug - Active disease at enrollment (less than 2 weeks before initiating treatment with a study drug), Which is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 1.0 mg/dL Exclusion criteria - Assessed as having Class IV Steinbrocker functional activity in the 4 weeks preceding treatment with the study drug - Treated with infliximab, etanercept or leflunomide in the 12 weeks preceding treatment with the study drug - Received any of the following therapies in the 2 weeks preceding initiation of treatment with the study drug. 1. Administration of any DMARD or immunosuppressant other than MTX 2. Administration of corticosteroids exceeding 10 mg/day as prednisolone 3. Dose escalation or initiation of corticosteroids - Received any of the following therapies in the 4 weeks preceding treatment with the study drug 1. Plasma exchange therapy 2. Surgical treatment (operation, etc.) | |
| 45 | NCT00523991 | completed | 1 | phase 4 | ['pulmonary disease, chronic obstructive'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['tiotropium', 'placebo'] | ['C[N+]1(C2CC(CC1C3C2O3)OC(=O)C(C4=CC=CS4)(C5=CC=CS5)O)C'] | Inclusion criteria: All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria: post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio < 70% (visit 1). Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of >=10 pack years. Subjects must have a Medical Research Council (MRC) dyspnea score >= 2. Exclusion criteria: Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening. Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids. Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year. | |
| 46 | NCT00286494 | completed | 1 | phase 3 | ['diabetes mellitus'] | ["['P70.2', 'O24.92', 'Z83.3', 'E10.65', 'E10.9', 'E11.65', 'E11.9']"] | ['alogliptin and pioglitazone', 'alogliptin and pioglitazone', 'pioglitazone'] | ['CCC1=CN=C(C=C1)CCOC2=CC=C(C=C2)CC3C(=O)NC(=O)S3.CN1C(=O)C=C(N(C1=O)CC2=CC=CC=C2C#N)N3CCCC(C3)N', 'CCC1=CN=C(C=C1)CCOC2=CC=C(C=C2)CC3C(=O)NC(=O)S3.CN1C(=O)C=C(N(C1=O)CC2=CC=CC=C2C#N)N3CCCC(C3)N', 'CCC1=CN=C(C=C1)CCOC2=CC=C(C=C2)CC3C(=O)NC(=O)S3'] | Inclusion Criteria - Diagnosis of type 2 diabetes mellitus currently treated with a thiazolidinedione either alone or in combination with metformin or a sulfonylurea but who are experiencing inadequate glycemic control. The subject should have received the thiazolidinedione therapy (rosiglitazone or pioglitazone) either alone or in combination with metformin or a sulfonylurea for at least the 3 months prior to Screening and must have been on a stable dose for all their antidiabetic treatments for at least the month prior to Screening. - No treatment with antidiabetic agents other than a thiazolidinedione alone or in combination with either metformin or a sulfonylurea within the 3 months prior to Screening. (Exception: if a subject has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.) - Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2 - Fasting C-peptide concentration greater than or equal to 0.8 ng per mL. (If this screening criterion is not met, the subject still qualifies if C-peptide is greater than or equal to 1.5 ng per mL after a challenge test.) - Glycosylated hemoglobin concentration between 7.0% and 10.0%, inclusive. - If regular use of other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator. - Systolic blood pressure less than or equal to 180 mm Hg and diastolic pressure less than or equal to 110 mm Hg. - Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal to10 g per dL for females. - Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal. - Serum creatinine less than or equal to 2.0 mg per dL. - Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid. - Neither pregnant nor lactating. - Female subjects of childbearing potential must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in the study. - Able and willing to monitor their own blood glucose concentrations with a home glucose monitor. - No major illness or debility that in the investigator's opinion prohibits the subject from completing the study. - Able and willing to provide written informed consent. Exclusion Criteria - Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If elevated, the subject may be rescreened within 1 week. - History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. (A history of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.) - History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening. - History of treated diabetic gastric paresis. - New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at Class I or II are candidates for the study. - History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening - History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin. - History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus. - History of a psychiatric disorder that will affect the subject's ability to participate in the study. - History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors. - History of alcohol or substance abuse within the 2 years prior to Screening. - Receipt of any investigational drug within the 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within the 3 months prior to Screening. - Prior treatment in an investigational study of alogliptin. - Excluded Medications: - Treatment with antidiabetic agents other than a thiazolidinedione alone or in combination with either metformin or a sulfonylurea is not allowed within the 3 months prior to Screening and through the completion of the end-of-treatment/early termination procedures. - Treatment with weight-loss drugs, any investigational antidiabetics, or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of-treatment/early termination procedures. Inhaled corticosteroids are allowed. Subjects must not take any medications, including over-the-counter products, without first consulting with the investigator. | |
| 47 | NCT00656916 | terminated | terminated due to slow accrual. | 0 | phase 2 | ['bronchiolitis'] | ["['J21.9', 'J84.115', 'J21.1', 'J21.0', 'J21.8']"] | ['fluticasone propionate'] | ['Status: 503'] | Inclusion Criteria: 1. Patients >/=18 years of age. 2. Patients must be engrafted and at least 80 days post allogeneic hematopoietic stem cell transplantation. 3. New onset airflow obstruction defined as decline of forced expiratory volume in 1 second (FEV1) percent predicted >/= 15%. 4. Total Lung Capacity (TLC) > 85% to rule out restrictive lung disease. 5. Patient must be willing to comply with all study procedures and capable of signing informed consent. Exclusion Criteria: 1. Patients with active pulmonary infection. 2. Patients with known hypersensitivity to corticosteroids |
| 48 | NCT01143077 | completed | 1 | phase 3 | ['schizophrenia', 'schizoaffective disorder'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']", "['F25.9', 'F25.0', 'F25.1', 'F25.8']"] | ['lurasidone hcl'] | ['Status: 503'] | Inclusion Criteria: - Subject ≥ 18 years of age. - Subject meets DSM-IV criteria for a primary diagnosis of schizophrenia or schizoaffective disorder. - Subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns. Exclusion Criteria: - Presence of an Axis I or Axis II disorder other than schizophrenia or schizoaffective disorder that is the primary focus of treatment prior to screening. - Subject has experienced persistent lack of improvement in psychotic symptoms despite adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic agents in the 12 months prior to screening. - Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or property. Subject has suicidal ideation at baseline or has attempted suicide within 90 days prior to randomization (even without hospitalization). | |
| 49 | NCT00593853 | terminated | slow accrual | 0 | phase 2 | ['prostatic neoplasms', 'fatigue'] | ["['B38.81', 'N42.31', 'Z87.430', 'N40.0', 'N40.1']", "['R53.83', 'G93.31', 'R53.82', 'R53.0', 'T67.6XXS', 'G93.32', 'T67.6XXA']"] | ['methylphenidate hydrochloride', 'matched placebo'] | ['COC(=O)C(C1CCCCN1)C2=CC=CC=C2.Cl'] | Inclusion: - Age > 18 and ≤ 85 years - Histologically confirmed prostate cancer - Currently receiving LHRH-agonist therapy for greater than 6 months with measurable fatigue, defined as a score of >1 on the Bruera global fatigue severity scale OR - Deemed eligible to commence LHRH-agonist therapy, with confirmation of fatigue at Screening Visit 2 - Have a serum PSA which is stable or decreasing based on the PSA trend over the last 2 values taken at least 2 months apart, with the more recent value taken at least 2 months after initiation of LHRH-agonist therapy. - Have adequate liver and renal function (Bilirubin ≤ 1.5 x ULN and AST, ALT and Serum Creatinine < 2 x ULN) - Able to swallow and retain oral medication - Life expectancy of at least 1 year - Able to read and write in English (and therefore accurately complete the required study questionnaires), understand instructions related to study procedures and give written informed consent. Exclusion: - Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (other exceptions are superficial bladder cancer or non-melanoma skin cancer) - Previous chemotherapy within the last 5 years - Anemia (Hemoglobin < 100 g/L) - Myocardial infarction within past 6 months - Any unstable serious co-existing medical condition(s) including but not limited to ; unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, Severe bleeding diseases or immune disorders - Severe depression as defined by CES-D score >27 - History of motor tics, seizures or a family history of Tourette's syndrome - Infection with HIV (Human Immunodeficiency Virus), HBV (Hepatitis B) or HCV (Hepatitis C) - Evidence of drug or alcohol abuse - Known hypersensitivity to methylphenidate - Possess any other contraindications to methylphenidate use |
| 50 | NCT00403481 | completed | 1 | phase 4 | ['hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['olmesartan medoxomil', 'olmesartan medoxomil plus hydrochlorothiazide'] | ['CCCC1=NC(=C(N1CC2=CC=C(C=C2)C3=CC=CC=C3C4=NNN=N4)C(=O)OCC5=C(OC(=O)O5)C)C(C)(C)O'] | Inclusion Criteria: - Patients diagnosed with Type II diabetes that are on stable treatment with hypoglycemic agents - Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mmHg but <200 mmHg and a MSDBP less than or equal to 114 mmHg following a 3 to 4-week single-blind placebo run-in period - The difference in MSSBP between Visits 3 and 4 or between Visits 4 and 4X must be less than or equal to 10 mmHg - Patients with a mean daytime (8AM - 4PM) SBP > 130 mmHg and less than or equal to 199 mmHg and a mean daytime DBP less than or equal to 114 as measured by an ambulatory blood pressure monitoring device (ABPM) following placebo run-in period - If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study Exclusion Criteria: - History of stroke or transient ischemic attack (TIA) within the last one year - History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months - Presence of overt proteinuria at screening - Severe hypertension (DBP greater than or equal to 115 mmHg or SBP greater than or equal to 200 mmHg) - Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome - Type I or Type II diabetes requiring insulin - Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease - Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter | |
| 51 | NCT01740089 | completed | 1 | phase 2/phase 3 | ['hepatitis', 'hepatitis c'] | ["['B00.81', 'B25.1', 'B26.81', 'B58.1', 'K75.4', 'A51.45', 'B17.2']", "['B18.2', 'B17.10', 'B17.11', 'B19.20', 'B19.21', 'B15.0', 'B15.9']"] | ['algeron', 'pegintron', 'ribavirin'] | ['Status: 503', 'Status: 503', 'Status: 503'] | Inclusion Criteria: 1. Signed informed consent to participate in the study. 2. Hepatitis С virus infection (genotypes 1а, 1b, 2, 3, 4) confirmed by a positive quantitative PCR (HCV RNA > 50 IU/ml). 3. Males and females aged from 18 to 70 years inclusive. 4. Body mass index of 18 - 30 kg/m inclusive. 5. Increased ALT level (> 40, < 400 IU/L), documented at least twice within the last 6 months. 6. Preserved protein synthetic liver function (i.e. INR < 1.7, albumin > 35 g/l). 7. No signs of hepatic encephalopathy or abdominal fluid retention according to clinical and ultrasound examination. 8. Fertile patients and their partners agree to use barrier contraception throughout the study and 7 months after its completion. Exclusion Criteria: 1. Intolerance of IFN alpha formulations, ribavirin or any components of these drugs according to the past medical history. 2. Infection by hepatitis B virus or HIV. 3. Past history of HCV treatment with IFN alfa or pegylated IFN alfa formulations. 4. Administration of interferons and/or interferon inducing drugs for any indication within 1 month prior to the enrollment into the study. 5. Cholestatic hepatitis (conjugated bilirubin, alkaline phosphatase, ALT levels of more than 5 ULN). 6. Decompensated liver cirrhosis confirmed by laboratory findings (Child-Pugh class B, С) or ultrasound examination. 7. Any documented autoimmune diseases. 8. Hematologic (hemoglobin < 130 g/L for males and < 120 g/L for females; neutrophils < 1.5 х109/L; platelets < 90 х109/L) or biochemical abnormalities (creatinine level of more than 1.5 ULN, creatinine clearance less than 50 mL/min). 9. Documented diagnosis of hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia). 10. Heavy depression, any other mental disorders, which in the Investigator's opinion can be contraindications for antiviral treatment. 11. Epilepsy and/or other functional disorders of the central nervous system. 12. Abnormal thyroid function (TTH level beyond the normal values). 13. Malignant neoplasms. 14. Pregnancy, lactation period. 15. Severe comorbidities (for example, severe hypertension, severe coronary heart disease, decompensated diabetes mellitus), which in the Investigator's opinion can be contraindications for antiviral treatment. 16. Documented rare hereditary diseases, such as intolerance of lactose, sucrose, fructose, lactase deficiency or glucose-galactose malabsorption. 17. Current alcohol or drug abuse, which in the Investigator's opinion can be contraindications for antiviral treatment or restrict treatment compliance. 18. Simultaneous participation in other clinical trials or prior participation in this or another clinical trial within less than 30 days after its completion. | |
| 52 | NCT01592747 | completed | 0 | phase 2 | ['autistic disorder', 'autism', "asperger's disorder", 'asperger syndrome', 'autism spectrum disorders', 'pervasive developmental disorder - not otherwise specified (pdd-nos)'] | ["['F84.0']", "['Z13.41']", "['F84.5']", "['F84.5']", "['Z16.12']", "['K09.0', 'Q50.1', 'F84.8', 'F84.9', 'G70.2', 'M27.0', 'F81.89']"] | ['memantine hydrochloride (hcl)', 'memantine hydrochloride (hcl)', 'placebo capsules'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: 1. Completed at least 12 weeks of exposure to study drug in lead-in study MEM-MD-91 (NCT01592786) 2. Met responder criterion at two consecutive visits separated by at least two weeks in lead-in study MEM-MD-91 3. Provide written informed assent, when developmentally appropriate, to participate in the study before conduct of any study-specific procedures. The parent/guardian/LAR must provide written informed consent before the patient's participation in the study. A separate written informed consent for the caregiver must also be obtained before the conduct of any study specific procedures 4. Have a knowledgeable caregiver who is capable of providing reliable information about the patient's condition, attending all clinic visits with the patient, and overseeing the administration of study drug. Every effort should be made to maintain the same caregiver as used in the lead-in study throughout this study 5. Have normal results from the physical examination, laboratory tests, ECG, and vital signs at Visit 1 of this study (last visit of Study MEM-MD-91). Any abnormal findings must be deemed not clinically significant by the Investigator and documented 6. Be able to speak and understand English sufficiently (or their native language if this can be accommodated by the site), as well as have a caregiver and parent/guardian/LAR who is able to speak and understand English sufficiently (or their native language if this can be accommodated by the site), to comprehend the nature of the study and to allow for the completion of all study assessments 7. Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study 8. Females who are 9 years and older or who have had onset of menses must have a negative urine pregnancy test at Visit 1 9. Age of 6 years to 12 years at the time of entry into lead in study MEM-MD-91 Exclusion Criteria: 1. Patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being 2. Significant risk of suicidality based on the Investigator's judgment, the Aberrant Behavior Checklist-Irritability subscale (ABC-I), or if appropriate, as indicated by a response of "yes" to questions 4 or 5 in the suicidal ideation section of the Children's C-SSRS (Columbia-Suicide Severity Rating Scale) or any suicidal behavior. 3. Patients with evidence or history of malignancy (other than excised basal cell carcinoma) or any significant hematologic, endocrine, cardiovascular (including any rhythm disorder), neurologic, respiratory, renal, hepatic, or gastrointestinal disease 4. Female patients of child-bearing potential who are not using or not willing to use a conventional method of contraception approved by the PI. Abstinence is an acceptable method of contraception 5. Patients requiring treatment with prohibited concomitant medications 6. Patients who, in the opinion of the Investigator, might not be suitable for the study 7. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its affiliates or partners, or the study center | |
| 53 | NCT01057407 | completed | 1 | phase 3 | ['chronic kidney disease', 'renal dialysis', 'renal insufficiency'] | ["['I12.9', 'N18.9', 'I12.0', 'D63.1', 'N18.1', 'N18.5', 'I13.0']", "['Z99.2', 'Z91.15', 'Z91.A5']", "['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']"] | ['asp1585', 'sevelamer hydrochloride'] | ['Status: 503', 'C=CCN.C1C(O1)CCl.Cl'] | Inclusion Criteria: - Chronic kidney disease patients on hemodialysis - Hyperphosphatemia - Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not been changed within 28 days - Written informed consent Exclusion Criteria: - Patients with gastrointestinal surgery or enterectomy - Patients with severe cardiac diseases - Patients with severe constipation or diarrhea - Patients with a history or complication of malignant tumors - Patients with uncontrolled hypertension - Patients treated with parathyroid intervention | |
| 54 | NCT01313637 | completed | 1 | phase 3 | ['pulmonary disease, chronic obstructive'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['gsk573719/gw642444 125/25mcg', 'gsk573719 125mcg', 'gw642444 25mcg', 'placebo only'] | ['Status: 400'] | Inclusion Criteria: - Diagnosis of COPD - 10 pack-year or greater history of cigarette smoking - Post-bronchodilator FEV1/FVC of <0.7 - Predicted FEV1 of 70% of normal or less - Modified Medical Research Council (mMRC) dyspnea score of 2 or greater Exclusion Criteria: - Women who are pregnant, lactating, or planning to become pregnant - Respiratory disorders other than COPD, including a current diagnosis of asthma - Clinically significant non-respiratory diseases or abnormalities that are not adequately controlled - Significant allergy or hypersensitivity to anticholinergics, beta2-agonists, or the excipients of magnesium stereate or lactose used in the inhaler delivery device - Hospitalization for COPD or pneumonia within 12 weeks prior to screening - Lung volume reduction surgery within 12 weeks prior to screening - Abnormal and clinically significant ECG findings at screening - Clinically significant laboratory findings at screening - Use of systemic corticosteroids, antibiotics for respiratory tract infections, strong cytochrome P450 3A4 inhibitors, high dose inhaled steroids (>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, ipratropium, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit - Use of long-term oxygen therapy (12 hours or greater per day) - Regular use of nebulized treatment with short-acting bronchodilators - Participation in the acute phase of a pulmonary rehabilitation program - A know or suspected history of alcohol or drug abuse - Affiliation with the investigational site - Previous use of GSK573719 or GW642444 alone or in combination, including the combination of fluticasone furoate and GW642444 | |
| 55 | NCT00418028 | completed | 0 | phase 2/phase 3 | ['metastatic breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['capecitabine'] | ['CCCCCOC(=O)NC1=NC(=O)N(C=C1F)C2C(C(C(O2)C)O)O'] | Inclusion Criteria 1. Patients diagnosed with metastatic breast cancer 2. Patients that either have received previous treatment with anthracyclines and/or taxanes or not (either as advance or in metastatic disease). 3. The patient is ambulatory with a functional ECOG < 2 status (see Appendix 2). 4. Patient presents, at least one lesion measurable according to RECIST criteria (see Appendix 3) 5. Patients with a life expectancy of at least 3 months. 6. Patients that agree to and are able to fulfill the requirements of the whole protocol through the whole study. Exclusion criteria: 1. Patients that have previously shown unexpected severe reactions to therapy with fluoropyrimidines or with a known sensitivity to 5-fluorouracile. 2. Patients previously treated with capecitabine. 3. Patients with organ transplants. 4. Other diseases or severe affections: 1. Patients with previous convulsions, central nervous system diseases or psychiatric diseases, including dementia, that the investigator might consider clinically significant and which adversely affect therapeutic compliance. 2. Patients with severe intellectual impairment, unable to carry out basic daily routines and established depression. 3. Clinical significant cardiac disease (e. g. . congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not fully controlled with medication) or myocardial infarction within the last 12 months. 4. Severe renal impairment (baseline creatinine clearance < 30 ml/min) 5. Patients with signs of metastasis in the CNS. Patients with a history of uncontrolled convulsions, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded. 6. Patients with an active infection. 7. Patients with a history of other neoplasias during the previous five years, except for basal cell skin cancer or cervical cancer in situ, both cured. 8. Patients showing the following laboratory values: 1. Neutrophil count < 555 x 109/l 2. Platelet count< 100 x 109/l 3. Serum creatinine > 1,5 x upper normality limit 4. seric bilirubin > 2,0 x upper normality limit 5. ALAT, ASAT > 2,5 x upper normality limit or > 5 x upper normality limit in case of liver metastases 6. Alkaline phosphatase > 2,5 x upper normality limit > 5 x upper normality limit in case of liver metastases o > 10 x upper normality limit in case of bone metastases. 9. Patients under radiotherapy four weeks prior to the initiation of the study treatment, or under previous radiotherapy on the marker lesions be measured during the study (new marker lesions that appear in previously irradiated areas are accepted) or patients who are receiving programmed radiotherapy. 10. Patients under major surgery within 4 weeks prior to study treatment or who have not completely recovered from the effects of major surgery. 11. Patients who lack upper gastrointestinal tract physical integrity or with malabsorption syndrome. 12. Patients who have received more than two cycles of chemotherapy for the metastatic disease. 13. Patients Her2 + per FISH ó +++ Immunohistochemistry | |
| 56 | NCT00192075 | completed | 0 | phase 2 | ['colorectal cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['gemcitabine', 'avastin', '5fu/folinic acid', 'oxaliplatin'] | ['C1=CN(C(=O)N=C1N)C2C(C(C(O2)CO)O)(F)F', 'Status: 400', 'C1CCC(C(C1)[NH-])[NH-].C(=O)(C(=O)O)O.[Pt+2]'] | Inclusion Criteria: - Patients must have a histological or cytological diagnosis of the colon or rectum with Stage III unresectable or Stage IV disease. - Urinalysis or Urine dipstick for proteinuria of less than 1+ (i.e. either 0 or trace). If urine dipstick is greater than 1+, the 24 hour urine protein must demonstrate less than 500 mg of protein in 24 hours to allow participation. - No prior chemotherapy, immunotherapy, or hormonal treatment for metastatic disease is acceptable. However, one prior neo-adjuvant or adjuvant treatment is acceptable, including Capecitabine, Camptothecin-11 (CPT-11), 5 Fluorouracil/Leucovorin (5FU/LV) or Radiation containing regimens, (but no Oxaliplatin), and only if progression > 6 months since last adjuvant treatment. - Prior radiation therapy, including radiation to the whole pelvis, is allowed (Cristy and Eckerman 1987) and patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. Prior palliative radiation therapy given to a non-measurable diagnostic site is acceptable if given > 4 weeks prior to treatment or if other non-irradiated measurable disease is present. - No known central nervous system (CNS) metastasis. Exclusion Criteria: - Histology other than adenocarcinoma - Tumors that demonstrate free perforation as manifested by free air or free fluid in the abdomen. Patients with walled-off perforation are eligible. - Gastroduodenal ulcer determined as active by endoscopy. - Invasive procedures defined as follows; major surgical procedures, open biopsy, or significant traumatic injury within 28 days prior to randomization, anticipation of need for major surgical procedure during the course of study, core biopsy or other minor procedure within 7 days prior to registration. - Following cardiac condition; New York Heart Association (NYHA) Class III or IV, myocardial infarction (MI) within 6 months, unstable angina within 6 months and current symptomatic arrhythmia. | |
| 57 | NCT01515540 | completed | 1 | phase 4 | ['low back pain'] | ["['M54.50', 'M54.51', 'M54.59']"] | ['lidocaine', 'placebo'] | ['CCN(CC)CC(=O)NC1=C(C=CC=C1C)C'] | Inclusion Criteria: 1. Male or Female 18 years or older of age 2. Pain in the location of the lower back 3. Pain duration for a minimum of 6 months on a continuous basis 4. Pain intensity of at least 3 out of 10 on most days of the week over the past six months 5. Manifestations of radicular element of pain: radiation below knee (examples towards thigh, buttocks). 6. Right handedness Exclusion Criteria: 1. Applying for or currently receiving workers' compensation or disability status. 2. Back pain secondary to spinal cord injury 3. Back pain secondary to any systemic condition (e.g ankylosing spondylitis0 4. Diabetes mellitus 5. Back pain secondary to tumors. 6. Standard MRI criteria re: claustrophobia, metal objects etc. 7. Subjects with cognitive deficits such as dementia, psychiatric illness including depression with a BDI score of more than 19 (moderate to severe depression), history of brain injury, history of chronic disease 8. Pregnant and/or lactating women 9. Left handedness 10. Active cancer 11. Other serious painful condition (e.g., arthritis) | |
| 58 | NCT00262587 | completed | 1 | phase 4 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['seretide', 'placebo'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - Elite athletes - Informed consent - Doctor diagnosed asthma Exclusion Criteria: - Current smoker or more than 10 pack-years - Pregnancy, breast feeding or planning pregnancy during the study. - ICS within the last 4 weeks prior to visit 1. | |
| 59 | NCT00600275 | completed | 0 | phase 1/phase 2 | ['solid tumors', 'breast cancer', 'cowden syndrome'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['bgt226'] | ['CN1C2=CN=C3C=CC(=CC3=C2N(C1=O)C4=CC(=C(C=C4)N5CCNCC5)C(F)(F)F)C6=CN=C(C=C6)OC'] | Inclusion criteria: All patients - Histologically-confirmed, advanced solid tumors - Progressive, recurrent unresectable disease Phase II expansion part (advanced breast cancer) - Confirmed positive hormone receptor (estrogen receptor and/or progesterone receptor) or positive HER-2 expression status - Disease progression/recurrence following hormonal or anti-HER-2 treatment for advanced disease - At least one but not more than two prior chemotherapy regimens for the unresectable tumor - Measurable disease by MRI or CT scan Cowden Syndrome patients with an advanced malignancy Genetic confirmation of Cowden Syndrome - Age ≥ 18 - World Health Organization (WHO) Performance Status of ≤ 2 Exclusion criteria: - Hematopoietic: - No diabetes mellitus or history of gestational diabetes mellitus - No acute or chronic renal disease - No acute or chronic liver disease - No acute or chronic pancreatitis - No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension - No acute myocardial infarction or unstable angina pectoris within the past 3 months - Not pregnant or nursing and fertile patients must use barrier contraceptives Other protocol-defined inclusion/exclusion criteria may apply. | |
| 60 | NCT00557830 | terminated | the study was closed to enrollment when it became clear that enrollment was too slow to complete the full enrollment target within the time frame allowed. | 0 | phase 2 | ['renal cell carcinoma'] | ["['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']"] | ['sorafenib escalated dose', 'sorafenib standard dose'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - Age ≥18 years old. - Diagnosis of unresectable/metastatic renal cell carcinoma (RCC). Nonclear cell histology is permitted (except for medullary, collecting duct, or sarcomatoid >50% of specimen). Prior metastasectomy is permitted as long as there is measurable disease at time of consent. - Karnofsky Performance Status of 50% or greater at study entry. - Adequate bone marrow, liver and renal function as assessed by the following: o Hemoglobin ≥ 9.0 g/dL. o ANC ≥ 1500/mm3. o Platelet count ≥ 100,000/mm3. o Total bilirubin ≤ 1.5 ULN. o ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver involvement). o Creatinine ≤ 1.5 × ULN. - Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to the start of treatment. - Women of childbearing potential and sexually active men must agree to use adequate barrier contraception prior to study entry, for the duration of study participation, and for at least three months after the last administration of sorafenib. - INR < 1.5 or a PT/ PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable. - Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures. Exclusion Criteria: - Prior systemic anticancer treatment for metastatic disease, including investigational therapy. - Prior treatment with bevacizumab, sunitinib, or sorafenib even in the adjuvant setting. - Prior cytokine therapy with interleukin (IL)-2 or interferon (IFN) for metastatic disease. - Active malignancy other than RCC (except non-melanoma skin cancer) within 5 years of enrollment. - Hemodialysis or peritoneal dialysis. - Treatment with radiotherapy within 2 weeks of enrollment. - Cardiac disease: Congestive heart failure Class II or higher per NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months. - Uncontrolled CNS metastases. All patients must undergo a CT) scan/MRI of the brain to exclude brain metastasis. Patients with adequately treated CNS disease may be considered for participation as long as the first dose of sorafenib is 4 weeks after completion of CNS therapy. - Uncontrolled hypertension defined as SBP > 150 mmHg or DBP > 90 mmHg, despite optimal medical management. - Active clinically serious infection > Grade 2 per the CTCAE v3. - Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months. - Pulmonary hemorrhage/bleeding event ≥ Grade 2 per CTCAE v3.0 within 4 weeks of administration of the first dose of study drug. - Any other hemorrhage/bleeding event ≥ Grade 3 per CTCAE v3.0 within 4 weeks of administration of the first dose of study drug. - Serious non-healing wound, ulcer, or bone fracture. - Evidence or history of bleeding diathesis or coagulopathy. - Major surgery, open biopsy or significant traumatic injury within 4 weeks of administration of the first study drug dose. - Use of St. John's Wort, rifampin (rifampicin), phenytoin, Phenobarbital, carbamazepine, dexamethasone. - Known or suspected allergy to sorafenib or any agent given in the course of this trial. - Any condition that impairs patient's ability to swallow whole pills. - Any malabsorption problem. - Pregnancy or lactation. |
| 61 | NCT00483977 | terminated | met criteria for study futility at interim analysis | 0 | phase 2 | ['osteoarthritis'] | ["['M15.4', 'M15.0', 'M16.9', 'M17.9', 'M19.011', 'M19.012', 'M19.019']"] | ['oxycodone', 'placebo', 'pf-000592379'] | ['CN1CCC23C4C(=O)CCC2(C1CC5=C3C(=C(C=C5)OC)O4)O'] | Inclusion Criteria: - Male or female of any race - Between the ages of 18 and 75 years - Knee Pain due to osteoarthritis Exclusion Criteria: - Pregnant - Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline - History of malignancy, convulsions, chronic infections, arthroscopy of the worst knee within the past year |
| 62 | NCT00691912 | terminated | study was stopped due because recrutation.was much slower as anticipated. | 0 | phase 2 | ['metastatic breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['liposomal doxorubicin', 'myocet / paclitaxel'] | ['CC1C(C(CC(O1)OC2CC(CC3=C2C(=C4C(=C3O)C(=O)C5=C(C4=O)C(=CC=C5)OC)O)(C(=O)CO)O)N)O', 'Status: 400'] | Inclusion Criteria: - Women >/= 18 years with histologically proven metastatic breast cancer - No prior chemotherapy in the advanced situation - ECOG </= 2 - Adequate bone marrow reserve - left ventricular ejection fraction (LVEF) >/= 50, measured within 4 weeks before study treatment - Existence of written informed consent Exclusion Criteria: - Previous high dose therapy with stem cell support - Prior adjuvant treatment with cumulative anthracycline dose of 600 mg/m² Epirubicin, 300 mg/m² Doxorubicin, 80 mg/m² Mitoxantrone - Concomitant hormon- or chemotherapy or radiation therapy - Her2/neu overexpression - pregnancy or breast feeding |
| 63 | NCT00830245 | terminated | low accrual rate | 0 | phase 2 | ['leptomeningeal carcinomatosis', 'non-small cell lung cancer'] | ["['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['erlotinib'] | ['COCCOC1=C(C=C2C(=C1)C(=NC=N2)NC3=CC=CC(=C3)C#C)OCCOC'] | Inclusion Criteria: 1. Age >18 2. Histologically or pathologically proven non-small cell lung cancer (NSCLC) 3. Leptomeningeal carcinomatosis confirmed by CSF cytology 4. A patients with EGFR mutation (including exon 19 deletion, L858R) 5. ECOG performance status 0-3 6. Expected life time more than at least 4 weeks 7. A patients who signed the informed consent prior to the participation in the study 8. Chemotherapy-naïve patient is eligible 9. Previous EGFR TKI is allowed if this drug was not specifically used for CNS metastases Exclusion Criteria: 1. A pregnant or lactating patient 2. A patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.) 3. A man or woman of childbearing potential without the willingness to use a contraceptive measures during the study 4. A patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer 5. A patient with active interstitial lung disease, except simple lymphangitic lung metastasis 6. A patient with history of allergic reaction to gefitinib or erlotinib 7. The following laboratory test results: - Number of absolute neutrophils counts (ANC) < 1.0ⅹ109/L - Number of platelets < 50 ⅹ109/L - AST, ALT > 2.5 ⅹupper limit of normal - Total bilirubin > 1.5 ⅹupper limit of normal - Serum creatinine > 1.5 ⅹupper limit of normal 8. A patient with serious disease as followings - Uncontrolled cardiac arrhythmia - History of myocardial infarction within 6 months prior to the initiation of study - Neurological or psychiatric disorder including dementia or uncontrolled seizure 9. A patient who refused to sign the informed consent |
| 64 | NCT00558467 | completed | 0 | phase 2 | ['tourette syndrome'] | ["['F95.2']"] | ['pramipexole immediate release (ir)', 'placebo'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - Male of female patients 6-17 yrs. - Written informed consent. - Diagnosed with Tourette's Disorder with a > or equal to 22 on the Total Tic Score at baseline. - Diagnosed with Tourette's Disorder when administering the Diagnostic Interview Schedule for Children. - Having at least 1 tic/day. - Women of childbearing age must have a negative serum pregnancy test at screening and must use a medically accepted contraceptive method. - Either a newly diagnosed patient or a patient diagnosed with Tourette's Disorder who can safely discontinue treatment. - Having a body weight of > or equal to 20 kg (44 lbs). Exclusion Criteria: - Any women of childbearing age having a positive serum pregnancy test at screening. - Patients who have clinically significant renal disease or serum creatinine greater than 1.0 mg/dL at screening. - Lab results at screening: hemoglobin below lower limit of normal which is determined to be clinically significant; Thyroid Stimulating Hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significant; clinically significant abnormalities in labs. - Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease which would preclude the patient from participating in this study. - History of Schizophrenia or any psychotic disorder, history of mental disorders or any present Axis I psychiatric disorder according to Diagnostic and Statistic Manual of Mental Disorders Fourth Edition (DSM-IV) requiring any medical therapy except for patients with a diagnosis of attention deficit hyperactivity disorder (ADHD) or obsessive-compulsive disorder (OCD) who are not on therapy. - History of/or clinical signs of epilepsy or seizures other than fever related seizures in early childhood. - History of/or clinical signs of any malignant neoplasm. - Allergic response to pramipexole. - Had previous treatment with dopamine agonists other than pramipexole within 14 days prior to baseline visit. - Had any other medical treatment for Tourette's Disorder besides the study medication within 28 days prior to baseline visit. - Had withdrawal symptoms of any medication at screening or at the baseline visit. - Having a Kaufman Brief Intelligence Test (KBIT IQ) score <70 at screening. - Having a children's Yale-Brown obsessive-compulsive scale (CY-BOCS) score of >15 at baseline. - Patients who meet criteria for Restless Legs Syndrome and or Periodic Limb Movement disorder. - Patients with severe asthma. - Patients that have initiated psychotherapy for Tourette's Disorder, OCD or ADHD within 3 mths of starting the trial. - Patients receiving psychological, cognitive and/or behavioral treatments greater than 3 mths prior to start of trial for Tourette's Disorder, OCD, and/or ADHD who will have changes in treatment plan. | |
| 65 | NCT00301938 | completed | 0 | phase 1 | ['accelerated phase chronic myelogenous leukemia', 'adult acute megakaryoblastic leukemia (m7)', 'adult acute minimally differentiated myeloid leukemia (m0)', 'adult acute monoblastic leukemia (m5a)', 'adult acute monocytic leukemia (m5b)', 'adult acute myeloblastic leukemia with maturation (m2)', 'adult acute myeloblastic leukemia without maturation (m1)', 'adult acute myeloid leukemia with 11q23 (mll) abnormalities', 'adult acute myeloid leukemia with inv(16)(p13;q22)', 'adult acute myeloid leukemia with t(15;17)(q22;q12)', 'adult acute myeloid leukemia with t(16;16)(p13;q22)', 'adult acute myeloid leukemia with t(8;21)(q22;q22)', 'adult acute myelomonocytic leukemia (m4)', 'adult acute promyelocytic leukemia (m3)', 'adult erythroleukemia (m6a)', 'adult pure erythroid leukemia (m6b)', 'blastic phase chronic myelogenous leukemia', 'myelodysplastic/myeloproliferative neoplasms', 'previously treated myelodysplastic syndromes', 'recurrent adult acute lymphoblastic leukemia', 'recurrent adult acute myeloid leukemia', 'relapsing chronic myelogenous leukemia', 'secondary acute myeloid leukemia', 't-cell adult acute lymphoblastic leukemia', 'untreated adult acute lymphoblastic leukemia', 'untreated adult acute myeloid leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['C94.21', 'C94.22', 'C94.20']", "['C7A.1']", "['C93.01', 'C93.02', 'C93.00']", "['C93.Z1', 'C93.Z2', 'C93.91', 'C93.92', 'C93.01', 'C93.02', 'C93.Z0']", "['C92.01', 'C92.02', 'C92.00']", "['C92.01', 'C92.02', 'C92.00']", "['R19.5', 'H35.09', 'M26.50', 'M26.59', 'Q99.8', 'R06.89', 'R06.9']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['C92.51', 'C92.52', 'C93.11', 'C93.12', 'C93.31', 'C93.32', 'C92.50']", "['C94.01', 'C94.02', 'C94.00']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['D46.Z', 'D46.9', 'C94.6', 'D46.C']", "['C83.57', 'C83.50', 'C91.01', 'C91.02', 'C83.52', 'C83.56', 'C83.53']", "['G47.13', 'J01.41', 'K11.22', 'K12.0', 'N96', 'F33.8', 'G03.2']", "['M94.1', 'A68.9', 'A68.0', 'A68.1', 'M35.6']", "['D75.1', 'E26.1', 'N91.1', 'N91.4', 'N94.5', 'A51.41', 'A51.43']", "['C83.57', 'C83.50', 'C91.01', 'C91.02', 'C83.52', 'C83.56', 'C83.53']", "['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['7-hydroxystaurosporine', 'perifosine'] | ['Status: 503', 'CCCCCCCCCCCCCCCCCCOP(=O)([O-])OC1CC[N+](CC1)(C)C'] | Inclusion Criteria: - Histologically or cytologically confirmed hematologic malignancy of 1 of the following types: - Relapsed or refractory acute myelogenous leukemia (AML) - Patients with acute promyelocytic leukemia t(15;17) are eligible provided they failed a prior tretinoin and arsenic-containing regimen - Patients should be either refractory to both agents (absence of durable hematologic response) OR relapsed after a complete response duration of < 6 months - Relapsed or refractory pre-B-cell or T-cell acute lymphoblastic leukemia (ALL) - Chronic myelogenous leukemia (CML) in accelerated or blastic phase that is refractory to imatinib mesylate - Must have evidence of disease progression despite continued treatment with imatinib mesylate - AML arising in the setting of underlying myelodysplastic syndromes (MDS) and/or myeloproliferative disorders (MPD) - Secondary or therapy-related AML - De novo AML or pre-B-cell or T-cell ALL in adults > 60 years of age with poor-risk features, such as complex (≥ 3) or adverse cytogenetics - The following are considered adverse cytogenetic abnormalities for AML: - -5q - 7q- - 9q- - 20q- - abn12p - +21 - +8 - t(6;9) - t(6;11) - t(11;19) - -7 - -5 - inv3/t(3;3) - abn11q23 - abn17p - abn21q - t(9;22) refractory to imatinib mesylate - The following are considered adverse cytogenetic abnormalities for ALL: - t(9;22) refractory to imatinib mesylate - Hypodiploidy - t(4;11) - t(1;19) - Myelodysplastic Syndromes (MDS) meeting 1 of the following criteria: - Intermediate and high risk (i.e., International Prognostic Scoring System [IPSS] ≥ 1.5) MDS that is refractory or has progressed after treatment with azacitidine and/or decitabine - Intermediate and high risk (i.e., IPSS ≥ 1.5) MDS with a 5q- cytogenetic abnormality that is refractory or has progressed after treatment with lenalidomide, azacitidine, or decitabine - Intermediate 2 and high risk MDS without 5q- cytogenetic abnormality that is refractory or has progressed after azacitidine or decitabine - Original 5q must also be refractory to lenalidomide - Received OR ineligible for established curative regimens, including stem cell transplantation - No active CNS leukemia - ECOG performance status (PS) 0-2 OR Karnofsky PS ≥ 60% - Total or direct bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST/ALT ≤ 2.5 times ULN - Creatinine ≤ 2 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after completion of study treatment - No hyperleukocytosis (i.e., WBC > 30,000/mm^3) (recent treatment with hydroxyurea to prevent impending leukostasis allowed provided there has been no dose increase for ≥ 1 week) - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to UCN-01 or perifosine - No intrinsic impaired organ function - No active, uncontrolled infection - Infection that is controlled with antibiotics allowed - No symptomatic cardiac disease - No active ischemia on EKG - LVEF ≥ 40% by echocardiogram or MUGA - Patients with a history of cardiac disease or mediastinal radiation should undergo testing of ventricular function - No poorly controlled diabetes mellitus - No psychiatric illness or social situation that would preclude giving informed consent or complying with study requirements - No HIV positivity - See Disease Characteristics - At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for carmustine or mitomycin C) and recovered - At least 4 weeks since prior radiotherapy and recovered - At least 4 weeks since prior autologous stem cell transplantation (SCT) - At least 90 days since prior allogeneic SCT - No evidence of graft vs host disease - At least 2 weeks since prior immunosuppressive therapy - No concurrent hematopoietic growth factors or biologic agents - No other concurrent investigational agents, chemotherapy, radiotherapy, or immunotherapy - No other concurrent anticancer therapy | |
| 66 | NCT00403637 | completed | 1 | phase 2/phase 3 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['indacaterol maleate'] | ['CCC1=C(C=C2CC(CC2=C1)NCC(C3=C4C=CC(=O)NC4=C(C=C3)O)O)CC.C(=CC(=O)O)C(=O)O'] | Inclusion Criteria: - Males and females 12 - 75 years of age with a diagnosis of persistent asthma - Daily treatment with a bronchodilator and daily dose of at least 100 µg beclomethasone dipropionate or equivalent - FEV1 at Visit 1 at least 50% of the predicted normal value - FEV1 reversibility at least 15% Exclusion Criteria: - Use of tobacco products within 6 months prior to Visit 1 or a smoking history of more than 10 pack years - Chronic Obstructive Pulmonary Disease (COPD) - Seasonal allergy where asthma is likely to deteriorate during the period of the study - Emergency room treatment for an acute asthma attack within the previous 6 weeks or hospitalized within the previous 6 months - A respiratory tract infection within the previous 6 weeks Other protocol-defined exclusion criteria may apply | |
| 67 | NCT00265785 | terminated | closed due to poor accrual | 0 | phase 2 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['pemetrexed'] | ['Status: 503'] | DISEASE CHARACTERISTICS: - Histologically confirmed bronchoalveolar carcinoma (BAC) or BAC variants such as adenocarcinoma with BAC features or BAC with invasive adenocarcinoma - Cytology specimens, such as bronchial brushings, washings, or fine needle aspiration specimens alone are not acceptable for diagnosis - Stage IV disease OR selected stage IIIB (T4 [secondary to malignant pleural effusion only], any N, M0) disease - Incompletely resected or unresectable disease - Pleural effusions, ascites, or laboratory parameters cannot be only evidence of disease - Measurable disease or nonmeasurable disease documented by CT scan - No known brain metastases PATIENT CHARACTERISTICS: - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - SGOT and SGPT ≤ 2.5 times ULN ( ≤ 5 times ULN if due to liver metastases) - Alkaline phosphatase ≤ 2.5 times ULN ( ≤ 5 times ULN if due to bone metastases) - Creatinine clearance ≥ 45 mL/min OR creatinine ≤ 1.5 times ULN - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 75,000/mm³ - Zubrod 0-2 - No history of allergic reaction to compounds of similar chemical or biological composition as pemetrexed disodium - Must provide smoking history - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission - Not pregnant or nursing - Fertile patients must use effective contraception - Able to swallow pills PRIOR CONCURRENT THERAPY: - No more than 2 prior systemic therapies (including epidermal growth factor receptor inhibitor) - At least 28 days since prior systemic therapy - Patients treated with prior erlotinib or gefitinib must have shown progression since treatment - No prior pemetrexed disodium - At least 28 days since prior radiotherapy and recovered - Must have measurable or nonmeasurable disease outside previously irradiated area or a new lesion within previously irradiated area - At least 14 days since prior palliative radiotherapy and recovered - At least 28 days since prior thoracic or major surgery and recovered - No concurrent surgery - No other concurrent therapy (hormonal, biologic or radiotherapy) for this disease - No concurrent antiretroviral therapy - Patients should discontinue non-steroidal anti-inflammatory drugs (NSAIDs) with longer half lives (etodolac, ketordac, sulindac, naproxen, naproxen sodium, oxaprozin, nabumetone, diflunisal, salsalate, celecoxib, rofecoxib, valdecoxib, meloxicam, piroxicam) at least 5 days before and for 2 days following pemetrexed treatment |
| 68 | NCT00065325 | completed | 1 | phase 3 | ['locally advanced breast cancer', 'metastatic breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['fulvestrant', 'exemestane'] | ['CC12CCC3C(C1CCC2O)C(CC4=C3C=CC(=C4)O)CCCCCCCCCS(=O)CCCC(C(F)(F)F)(F)F', 'CC12CCC3C(C1CCC2=O)CC(=C)C4=CC(=O)C=CC34C'] | Inclusion Criteria: - Biopsy confirmation of Breast Cancer - Breast Cancer has continued to grow after having received treatment with an aromatase inhibitor - Postmenopausal women defined as a women who has stopped having menstrual periods - Evidence of hormone sensitivity - Written informed consent to participate in the trial Exclusion Criteria: - Previous treatment with Faslodex (fulvestrant) or Aromasin (exemestane) - Any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor - Treatment with an investigational or non-approved drug within one month - An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures - A history of allergies to any active or inactive ingredients of Faslodex or Exemestane (i.e. castor oil or Mannitol) | |
| 69 | NCT00567879 | terminated | the study was terminated early due to insufficient evidence of clinical benefit. | 0 | phase 1/phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['panobinostat', 'trastuzumab'] | ['Status: 503', 'Status: 503'] | Key Inclusion criteria: - Age > 18 year old - Confirmed HER2+ ve metastatic breast cancer - Prior treatment and progression on trastuzumab - Patients must have adequate laboratory values - Eastern Cooperative Oncology Group (ECOG) performance status of <2 Key Exclusion criteria: - Patients with active central nervous system (CNS) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months. - Impaired heart function or clinically significant heart disease - Impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of LBH589 - Ongoing diarrhea - Liver or renal disease with impaired hepatic or renal functions - Concomitant use of any anti-cancer therapy or certain drugs - Female patients who are pregnant or breast feeding - Patients not willing to use an effective method of birth control |
| 70 | NCT01023516 | completed | 0 | phase 2 | ['chronic obstructive pulmonary disease (copd)'] | ["['G91.1', 'I42.1', 'N11.1', 'J05.0', 'P28.42', 'G47.33', 'J44.9']"] | ['azd9668', 'placebo'] | ['CC1=C(C=C(C(=O)N1C2=CC=CC(=C2)C(F)(F)F)C(=O)NCC3=NC=C(C=C3)S(=O)(=O)C)C4=CC=NN4C'] | Inclusion Criteria: - Diagnosis of COPD with symptoms over 1 year - FEV1/FVC < 70% and FEV1 >= 30 and < 80 % of predicted post-bronchodilator - Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation - At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit Exclusion Criteria: - Past history or current evidence of clinically significant heart disease - Current diagnosis of asthma - Patients who require long term oxygen therapy - Worsening of COPD requiring treatment with antibiotics, an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b | |
| 71 | NCT00329433 | completed | 1 | phase 2/phase 3 | ['deep venous thrombosis'] | ["['I81', 'K64.5', 'I51.3', 'I67.6', 'I74.11', 'I74.5', 'I74.8']"] | ['desirudin (iprivask™)', 'heparin'] | ['Status: 503', 'CC(=O)NC1C(C(C(OC1O)COS(=O)(=O)O)OC2C(C(C(C(O2)C(=O)O)OC3C(C(C(C(O3)CO)OC4C(C(C(C(O4)C(=O)O)O)O)OS(=O)(=O)O)OS(=O)(=O)O)NS(=O)(=O)O)O)OS(=O)(=O)O)O'] | Inclusion Criteria: - Patients who are scheduled for elective Cardiac or Thoracic Surgery. - Age > 18 years of age. Exclusion Criteria: - Patients with a clinical suspicion or a documented history of DVT/PE - Patients who may require anticoagulation during the post-op period. (i.e. Patients with a history of A-fib, scheduled for a MAZE procedure or placement of a mechanical valve, or those on Coumadin/IV heparin preoperatively) - Patients who have a history of HIT or if there is a suspicion of the patient having HIT pre-operatively. - Documented allergy to heparin, desirudin, or lepirudin - Patients with a history of coagulation disorder - Platelet count< 100 X109 /dl - Active bleeding - Serum Creatinine ≥ 1.5 mg/dl or CrCl ≤ 30 ml/min - Patients with a baseline coagulopathy (INR > 1.5 or aPTT > 45 sec) - Patients with liver disease - Pregnancy - Patients who require ventricular assist devices before or after surgery | |
| 72 | NCT00652158 | terminated | 0 | phase 1 | ['advanced malignancies'] | ["['K74.02', 'G47.22', 'H35.3133', 'H35.3134', 'H35.3113', 'H35.3114', 'H35.3123']"] | ['mln8054'] | ['Status: 503'] | Inclusion Criteria: Each patient must meet all of the following inclusion criteria to be enrolled in the study: - Has a histologically or cytologically confirmed metastatic and/or advanced malignancy (including lymphomas but excluding malignancies with extensive bone marrow involvement such as leukemias and multiple myeloma) for which standard treatment does not offer curative or life-prolonging potential - Aged 18 years or more - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Expected survival longer than 3 months from enrollment in the study - Radiographically or clinically evaluable tumor; however, measurable disease is not required for participation in this study - Suitable venous access for the conduct of blood sampling for determination of MLN8054 plasma concentrations - Willingness to have serial skin punch biopsies obtained and, if feasible, to have serial biopsies of tumor tissue obtained before and following the first dose of MLN8054 Note: Once the relationship between drug exposure and inhibition of Aurora A kinase activity has been established, patients subsequently enrolled in the study will not be required to undergo either tumor or skin biopsies. 8. Recovered from the reversible effects of prior antineoplastic therapy with at least 4 weeks elapsed since the last exposure to cytotoxic chemotherapy or radiotherapy and at least 6 weeks elapsed since exposure to nitrosoureas or mitomycin C. Patients treated with fully human monoclonal antibodies must not have received treatment with such antibodies for at least 6 weeks, and those treated with chimeric monoclonal antibodies must not have received treatment with such antibodies for at least 4 weeks. Patients treated with noncytotoxic small molecule drugs (eg, tyrosine kinase inhibitors such as Tarceva and hormonal agents such as Femara®) must not have received treatment with these drugs for at least 2 weeks before the first dose of MLN8054 is given. - Male patients must use an appropriate method of barrier contraception (ie, condoms) and inform any sexual partner that she must also use a reliable method of contraception (eg, a hormonal contraceptive, an intrauterine device, or diaphragm with spermicide) during the study and for 3 months after the last dose of study treatment. - Female patients must be postmenopausal, surgically sterilized, or willing to use reliable methods of birth control (eg, a hormonal contraceptive, an intrauterine device, diaphragm with spermicide, or abstinence) during the study and for 3 months after the last dose of study treatment. They should inform any male sexual partner to use an appropriate method of barrier contraception (ie, condoms) as well. - Able to give informed consent before the conduct of any study-related procedure not part of normal medical care and able to comply with the protocol Exclusion Criteria: Patients meeting any of the following exclusion criteria are not to be enrolled in the study: - Pregnant or lactating - Major surgery within the 21 days preceding the first dose of study treatment - Infection requiring antibiotic therapy within the 7 days preceding the first dose of study treatment - Life-threatening illness unrelated to cancer - Ongoing nausea or vomiting greater than Grade 1 in severity. Patients who require ongoing treatment with metoclopramide to control nausea or vomiting, to the point that it is Grade 1 or less in severity, are allowed to participate in this trial. - Diarrhea greater than Grade 1 in severity. Patients who require ongoing therapy with an antimotility agent to control diarrhea to a Grade 1 or lower level are not allowed to participate in this trial. - Known GI disease that could interfere with the oral absorption or tolerance of MLN8054 - Difficulty swallowing capsules - Inability to remain nothing by mouth (NPO), except for water and prescribed medications, for 2 hours preceding and 2 hours following each dose of MLN8054 - Received more than 4 previous cytotoxic chemotherapeutic regimens including regimens used as adjuvant or neo-adjuvant therapies. There is no limit on the number of noncytotoxic therapies (eg, hormonal and immunologic) that patients may have received. Tyrosine kinase inhibitors (eg, Tarceva and Iressa®) are considered noncytotoxic compounds. - Prior treatment with high-dose chemotherapy, defined as chemotherapy requiring the use of peripheral blood or bone marrow stem cell support for hematopoietic reconstitution - Prior treatment with radiation therapy involving greater than or equal to 25% of the hematopoietically active bone marrow - Clinical and/or radiographic evidence of cerebral metastases. However, patients who have a history of CNS metastasis but have no radiographic or clinical evidence of residual tumor (eg, following complete surgical resection) are not excluded from participation in this study. - Absolute neutrophil count <1.5 x 106/ul; platelet count <100 x 106/ul. - Serum creatinine >1.6 mg/dL or a measured or estimated (Cockcroft-Gault formula) creatinine clearance <30 mL/minute - Bilirubin >1.25 times the upper limit of the normal range (ULN); aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >2 times the ULN, and alkaline phosphatase (ALP) >2 times the ULN. Both the AST and ALP may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of metastatic disease to liver and/or to bone; however, the ALT must in all circumstances be <2 times the ULN. - Abnormalities or arrhythmias on 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, are considered to be clinically significant - Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status or known or suspected active hepatitis C infection - Known or suspected disorder of bilirubin metabolism or excretion including, but not limited to, Gilbert's syndrome, Crigler-Najjar syndrome, Dubin-Johnson syndrome, and Rotor syndrome - Inclusion in a trial of an investigational drug in the previous 4 weeks - Admission of alcohol abuse or an inability to restrict consumption of alcohol to no more than 1 standard unit of alcohol per day during the study and for 21 days from the last dose of study treatment. A standard unit of alcohol is defined as one 12 oz beer, 1.5 oz of 80 proof alcohol, or one 6 oz glass of wine. Note: criteria 22, 23, and 24 apply only to patients in whom biopsy of tumor tissue is planned. - aPTT and/or PT exceeding the ULN - Known bleeding diathesis or history of abnormal bleeding - Ongoing therapy with an anticoagulant (eg, aspirin, plavix, coumadin, heparin) | |
| 73 | NCT00330876 | completed | 1 | phase 3 | ['hypercholesterolemia', 'dyslipidemias'] | ["['E78.01', 'E78.00', 'Z83.42']"] | ['pitavastatin'] | ['C1CC1C2=NC3=CC=CC=C3C(=C2C=CC(CC(CC(=O)O)O)O)C4=CC=C(C=C4)F'] | Inclusion Criteria: - Greater than or equal to 65 years of age - Primary hypercholesterolemia - Combined dyslipidemia - Completed study NK-104-306 (NCT00257686) Exclusion Criteria: - Failed to complete study NK-104-306(NCT00257686) | |
| 74 | NCT00413764 | completed | 1 | phase 3 | ['sexual dysfunction'] | ["['R37', 'N53.8', 'N53.9', 'F10.181', 'F10.281', 'F11.181', 'F11.281']"] | ['tibolone', 'estradiol-norethisterone'] | ['CC1CC2=C(CCC(=O)C2)C3C1C4CCC(C4(CC3)C)(C#C)O'] | Inclusion Criteria: - Physically and mentally healthy postmenopausal women, >=48 and <=68 years of age, with an intact uterus. - Women were to suffer from decreased satisfactory sexual activity compared to younger age and sexual problems were not to be considered caused by relationship/partner problems. The decreased sexual functioning was to result in sexually related personal distress as confirmed by the FSDS (score =15). - An affirmative answer was to be given to the following questions: (a) In previous years did you find sexual activity satisfying? (b) Has there been a decline in your satisfaction with sexual activity? (c) Are you satisfied with your partner as a friend? - All subjects were to have an established sexual relationship of at least 6 months duration prior to screening. - Women were to be sexually active. - Normal mammography within 6 months prior to randomization. - Body mass index >18 and <=32 kg/m2. - Voluntary written informed consent Exclusion Criteria: - Any unexplained abnormal uterine bleeding - Double layer endometrial thickness >4 mm - Tibolone or transdermal E2/NETA use within 3 months prior to screening - Progestogen implants or injections and estrogen/progestogen injectable therapy within 6 months prior to screening - Use of intra-uterine progestogen - Unsuccessful previous treatment with androgens or compounds known to enhance androgenic activity - Current successful treatment with androgens, without applying the applicable washout period of 3 months prior to screening - Any previous or current unopposed estrogen administration, prior use of estrogen pellets or tamoxifen citrate (previous low dose vaginal estrogen-only applications are allowed) - Use of anti -androgens within the preceding 5 years prior to screening. - Women with significant organic disorder of sexual dysfunction or a partner with sexual dysfunction - Women who had early onset sexual dysfunction (>15 years prior to menopause) - Women suffering from androgenic alopecia, acne or hirsutism - Women suffering from illnesses influencing sexuality - Women using medication influencing sexuality - Moderate to severe depression - Current or prior use of antidepressant within 8 weeks prior to screening - Major gynecological surgery in the preceding 3 months - Any serious disease or disorder; or any endocrine disorder with systemic disease which would have impaired overall health and well being (controlled hypo/hyperthyroidism and diabetes mellitus Type II was allowed) - History or presence of severe psychiatric illness and/or any addictions to drugs, medication or alcohol in the past 3 years - Diseases for which exogenous hormonal steroids were contraindicated. - History or presence of any malignancy, except successfully treated non-melanoma skin cancers - History or presence of cardiovascular or cerebrovascular conditions, thrombosis or thromboembolic disorders - History or presence of liver, gallbladder or renal disease, epilepsy or classical migraine headaches - Uncontrolled hypertension - Women with abnormal cervical smear results - History or presence of breast cancer, suspicious breast lump or mammographic abnormality - Known hypersensitivity to any of the ingredients of the trial medication. - Non-compliance with the screening diary - Current use of raloxifene, clonidine, veralipride, phytoestrogen extracts - Drugs known to interfere with the pharmacokinetics of the steroids - Use of investigational drugs within the past 60 days - Any disease or condition that was clinically relevant and which, in the opinion of the investigator, would have jeopardized the subject's well being during the course of the trial | |
| 75 | NCT00084864 | terminated | sample size is too small to draw a conclusion | 0 | phase 2 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['dexamethasone'] | ['CC1CC2C3CCC4=CC(=O)C=CC4(C3(C(CC2(C1(C(=O)CO)O)C)O)F)C'] | DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Organ-confined disease - cT1, cT2, or cT3 tumors - Patients with cT1 tumors are eligible if ≥ 1 core biopsies have ≥ 50% of the tumor OR if 50% of the cores examined contain the tumor - No small cell carcinoma of the prostate - Scheduled for radical prostatectomy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - Platelet count ≥ 100,000/mm^3 - WBC ≥ 3,500/mm^3 Hepatic - ALT and AST ≤ 4 times normal - Bilirubin ≤ 2 mg/dL Renal - Creatinine ≤ 2 times upper limit of normal - Calcium ≤ 10.5 mg/dL - No detectable renal stones by CT scan or ultrasound Other - No history of diabetes mellitus requiring pharmacotherapy PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - More than 5 years since prior antiestrogens, antiandrogens, luteinizing hormone-releasing hormone agonists, estrogen, or progestational agents Radiotherapy - Not specified Surgery - See Disease Characteristics - No prior nephrectomy - No prior prostatic surgery - No prior cryotherapy or transurethral resection of the prostate |
| 76 | NCT01422720 | completed | 1 | phase 3 | ['epilepsy'] | ["['G40.803', 'G40.804', 'G40.911', 'G40.919', 'G40.B11', 'G40.B19', 'G40.801']"] | ['eslicarbazepine acetate'] | ['CC(=O)OC1CC2=CC=CC=C2N(C3=CC=CC=C13)C(=O)N'] | Inclusion Criteria: 1. Written informed consent form; 2. Of age 65 years or older; 3. A documented diagnosis of epilepsy for at least 12 months, 4. At least 2 partial-onset seizures (including subtypes of simple partial, complex partial and/or partial seizures evolving to secondarily generalised) in the 4 weeks prior to screening; 5. Currently treated with 1 or 2 AEDs (any except oxcarbazepine) in a stable dosage regimen for at least 4 weeks prior to screening. Vagus nerve stimulation (VNS) is to be considered as an AED (i.e., only one concomitant AED is allowed in patients with VNS); 6. Willing and able to comply with all trial requirements, in the judgment of the investigator; 7. At least 2 partial-onset seizures (documented in the diary) per 4 weeks during the 8-week baseline period; 8. Satisfactorily complied with the study requirements during the baseline period Exclusion Criteria: 1. Only simple partial seizures with no motor symptomatology (classified as A2-4) according to the International Classification of Epileptic Seizures); 2. Primarily generalised seizures; 3. Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia; 4. Occurrence of seizures too close to count accurately; 5. History of status epileptic or cluster seizures 8i.e. 3 or more seizures within 30 minutes) within the 3 months prior to screening; 6. Seizures of non-epileptic origin; 7. Major psychiatric disorders; 8. History of suicide attempt; 9. Currently treated with oxcarbazepine; 10. Previous use of ESL or participation in a clinical study with ESL; 11. Known hypersensitivity to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients; 12. Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder, hypo - or hyper thyroidism of any type; 13. Second or third-degree atrioventricular blockade or any clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator; 14. Relevant clinical laboratory abnormalities as determined by the investigator (e.g. plasma sodium <130 mmol/L, alanine or aspartate aminotransferases >2.0 times above the upper limit of the range, or white blood cell count <3,000 cells/mm3; 15. Calculated creatinine values < 30 mL/min at screening; 16. Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol; 17. Received an investigational drug (or a medical device) within 3 months of screening or is currently participating in another trial of an investigational drug (or medical device) trial. | |
| 77 | NCT00351910 | completed | 1 | phase 3 | ['major depressive disorder'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['quetiapine', 'amitriptyline', 'bupropion', 'citalopram', 'duloxetine', 'escitalopram', 'fluoxetine', 'paroxetine', 'sertraline', 'venlafaxine'] | ['C1CN(CCN1CCOCCO)C2=NC3=CC=CC=C3SC4=CC=CC=C42', 'CN(C)CCC=C1C2=CC=CC=C2CCC3=CC=CC=C31', 'CC(C(=O)C1=CC(=CC=C1)Cl)NC(C)(C)C', 'CN(C)CCCC1(C2=C(CO1)C=C(C=C2)C#N)C3=CC=C(C=C3)F', 'CNCCC(C1=CC=CS1)OC2=CC=CC3=CC=CC=C32', 'CN(C)CCCC1(C2=C(CO1)C=C(C=C2)C#N)C3=CC=C(C=C3)F', 'CNCCC(C1=CC=CC=C1)OC2=CC=C(C=C2)C(F)(F)F', 'C1CNCC(C1C2=CC=C(C=C2)F)COC3=CC4=C(C=C3)OCO4', 'CNC1CCC(C2=CC=CC=C12)C3=CC(=C(C=C3)Cl)Cl', 'CN(C)CC(C1=CC=C(C=C1)OC)C2(CCCCC2)O'] | Inclusion Criteria: - Male or female aged 18 to 65 years - A documented diagnosis of major depressive disorder Exclusion Criteria: - Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment - Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the patient's current psychiatric status - Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment | |
| 78 | NCT00200967 | completed | 1 | phase 3 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['salmeterol', 'beclomethasone hfa'] | ['C1=CC=C(C=C1)CCCCOCCCCCCNCC(C2=CC(=C(C=C2)O)CO)O'] | Inclusion Criteria: - Male or female, ages 18 and older - Clinical history consistent with asthma - For subjects regularly using inhaled corticosteroids, FEV1 50% of predicted, methacholine PC20 FEV1 16 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs of inhaled albuterol - For subjects not regularly using inhaled corticosteroids, FEV1 40% of predicted, methacholine PC20 FEV1 8 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs of inhaled albuterol - Genotype eligibility (determined during screening) Exclusion Criteria: - Smoker (total smoking history must be less than 10 pack years) - Significant unstable medical condition other than asthma - History of life-threatening asthma requiring treatment with intubation and mechanical ventilation in the past 10 years - Pregnant or lactating | |
| 79 | NCT00551174 | completed | 1 | phase 4 | ['post-menopausal osteoporosis'] | ["['M81.6', 'Z82.62', 'Z13.820', 'M81.8', 'Z87.310', 'M81.0', 'M80.80XS']"] | ['ibandronate [bonviva/boniva]', 'ibandronate [bonviva/boniva]'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75% compliance - Ambulatory Exclusion Criteria: - Patients who completed the Bonviva study BM16550 (NCT00048074) >3 months before the planned start date for this study - Malignant disease diagnosed since inclusion into previous study - Treatment with drugs affecting bone metabolism since inclusion into previous study | |
| 80 | NCT00442104 | terminated | sponsor's decision | 0 | phase 2 | ['infantile spasms'] | ["['L70.4', 'L21.1', 'L20.83', 'H26.09', 'L44.4', 'M41.00', 'M41.02']"] | ['ganaxolone'] | ['CC(=O)C1CCC2C1(CCC3C2CCC4C3(CCC(C4)(C)O)C)C'] | Inclusion Criteria: - Have completed all scheduled clinical study visits in the previous Protocol 1042 0500 and have been deemed eligible (no SAEs thought to be drug related and had a response to treatment) by the Investigator. - Be diagnosed with IS regardless of etiology. Diagnostic Criteria: Seizures consisting of single or repetitive short muscular contractions leading to flexion or extension. Spasms may be characterized as tonic or myoclonic contractions, may occur singly or in clusters, and typically occur bilaterally and symmetrically. The EEG pattern must be consistent with the diagnosis of IS (hypsarrhythmia, modified hypsarrhythmia, multifocal spike wave discharges, etc). - Have a 24 hour vEEG recording confirming the diagnosis of IS. - Have had a magnetic resonance imaging (MRI) performed to determine any possible causes of IS. - Have been previously treated with 3 AEDs or fewer. - Have a parent/guardian who is properly informed of the nature and potential risks and benefits of the clinical study, is willing and capable of complying with all clinical study procedures, and has given informed consent in writing prior to entering the clinical study. Exclusion Criteria: - Current treatment with more than 2 concomitant AEDs. - Have an active CNS infection, demyelinating disease, degenerative neurological disease, or CNS disease deemed progressive (with the exception of tuberous sclerosis) as evaluated by brain MRI. - Have any disease or condition (medical or surgical) at Screening that might compromise the hematologic, cardiovascular, pulmonary, renal, GI, or hepatic systems; or other conditions that might interfere with the absorption, distribution, metabolism, or excretion of the investigational product, or would place the subject at increased risk. - Aspartate transaminase (AST), alanine transaminase (ALT), or total bilirubin greater than 4 times the upper limit of laboratory normal or any clinical laboratory value deemed clinically significant by the Investigator. - History of recurrent status epilepticus. - Have been exposed to any other investigational drug within 30 days prior to enrollment. |
| 81 | NCT01264081 | terminated | protocol would not be able to reach stated accrual. | 0 | phase 2 | ['malignant melanoma'] | ["['C43.0', 'C43.31', 'C43.51', 'C43.9', 'C43.4', 'C43.52', 'C43.10']"] | ['lapatinib'] | ['Status: 503'] | - INCLUSION CRITERIA: - Patients must have histologically confirmed stage IV cutaneous melanoma. - Patients must have measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be greater than 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or greater than 20 mm when measured by chest x-ray. Lymph nodes must be greater than 15 mm in short axis when measured by CT or MRI. - Patients must have no more than two oncogenic somatic ERBB4 mutations detected in one of the 28 exons of the ERBB4 gene analyzed from the tumor and which is not present in the matched normal deoxyribonucleic acid (DNA) as confirmed by sequence analysis of tumor genomic DNA derived from any biopsy specimen obtained at the participating clinical sites. Sequence analysis will be performed at the National Institutes of Health (NIH) Clinical Molecular Profiling Core, a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Note: Patients with 3 or more mutations in their ERBB4 gene may have an increased resistance to lapatinib and are not eligible for lapatinib treatment - Patients must not have had chemotherapy, molecular therapy with B-RAF, mouse embryonic fibroblast (MEK), or c-kit inhibitors, hormonal therapy, radiation therapy, or biological therapy for at least 4 weeks prior to starting study medication. Patients who received mitomycin C, nitrosoureas, anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4), or carboplatin must be 6 weeks from the last administration of therapy. Patients must have recovered from any acute toxicity related to prior therapy or surgery, to a grade 1 or less unless specified. - Patients with no more than 3 intracranial metastases, which have been definitively treated by surgery or radiation therapy may be eligible for study provided there is no evidence of active disease for at least 2 months and no requirement for anticonvulsant therapy or steroids following treatment. - Age greater than or equal to 18 years. Note: Because no dosing or adverse event data are currently available on the use of lapatinib in patients less than 18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable. - Life expectancy of greater than 3 months. - Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 (Karnofsky greater than or equal to 70%). - Patients must have normal organ and marrow function as defined below: - absolute neutrophil count greater than or equal to 1,500/mcL - platelets greater than or equal to 100,000/mcL - total bilirubin within normal institutional limits - Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase (SGOT))/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase (SGPT)) less than or equal to 3 times institutional upper limit of normal - creatinine less than or equal to institutional upper limit of normal OR --creatinine clearance greater than or equal to 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal. - Patients must be willing to return to the Clinic for follow-up visits. - Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) (serum or urine) within 14 days prior to study treatment and must be willing to practice effective birth control to prevent pregnancy while receiving treatment and for four months after treatment is discontinued. All males of child fathering potential must also be willing to practice effective birth control. Note: Lapatinib is a tyrosine kinase inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lapatinib, breastfeeding should be discontinued if the mother is treated with lapatinib. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately. - Ability to understand and the willingness to sign the Informed Consent Document. - Patients who agree to participate in the pharmacokinetics (PK) portion of the study must be able to swallow lapatinib tablets for the duration of the PK studies. EXCLUSION CRITERIA: - Patients may not be currently receiving any other investigational agents. - Patients may not have received prior treatment with tyrosine kinase inhibitors (e.g., lapatinib erlotinib, or gefitinib). - Patients currently receiving any medication known to induce/inhibit cytochrome P450 3A4 (CYP3A4) as listed in Appendix D, which in the opinion of the principal investigator, would make the administration of study drug hazardous. Note: patients receiving any strong or moderate CYP3A4 inhibitors will be excluded. - Patients with active hepatic or biliary disease (with exception of patients with Gilberts syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) - Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. - Human immunodeficiency virus (HIV)-positive patients on antiretroviral therapy are excluded because most antiretrovirals are strong or moderate CYP3A4 inhibitors. - Any underlying medical condition which, in the opinion of the principal investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events - Patients with any other concurrent malignancy, except for the following: - adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease-free for five (5) years or more. INCLUSION OF WOMEN AND MINORITIES: Both men and women and members of all races and ethnic groups are eligible for this trial. |
| 82 | NCT01580397 | completed | 0 | phase 2 | ['pancreatic ductal adenocarcinoma'] | ["['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']"] | ['inno-206'] | ['CC1C(C(CC(O1)OC2CC(CC3=C2C(=C4C(=C3O)C(=O)C5=C(C4=O)C(=CC=C5)OC)O)(C(=NNC(=O)CCCCCN6C(=O)C=CC6=O)CO)O)N)O'] | Inclusion Criteria: - Age ≥ 18 years of age; male or female. - Histologically or cytologically confirmed, locally advanced, unresectable, and/or metastatic pancreatic ductal adenocarcinoma. - Cancer progression after treatment with one gemcitabine and one fluoropyrimidine-containing chemotherapy regimen. - Capable of providing informed consent and complying with trial procedures. - ECOG performance status 0-1. - Life expectancy ≥ 8 weeks. - Measurable tumor lesions according to RECIST 1.1 criteria. - Women must not be able to become pregnant (eg post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.) - Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. - Geographic accessibility to the site. Exclusion Criteria: - Prior exposure to > 3 cycles or 225 mg/m2 of doxorubicin or Doxil®. - Palliative surgery and/or radiation treatment less than 4 weeks prior to Randomization. - Exposure to any investigational agent within 30 days of Randomization. - Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit). - History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥ 5 years. - Laboratory values: Screening serum creatinine > 1.5x upper limit of normal (ULN), alanine aminotransferase (ALT) > 3×ULN or > 5×ULN if liver metastases are present, total bilirubin > 3×ULN, absolute neutrophil count < 1,500/mm3, platelet concentration < 100,000/mm3, absolute lymphocyte count < 1000/mm3, hematocrit level < 27% for females or < 30% for males, or coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT], International Normalized Ratio [INR]) > 1.5×ULN, serum albumin ≤ 2.8 g/dL. - Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines. - Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V. - History or signs of active coronary artery disease with or without angina pectoris. - Serious myocardial dysfunction ultrasound-determined, with absolute left ventricular ejection fraction (LVEF) < 45% of predicted. - History of HIV infection. - Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals. - Major surgery within 4 weeks prior to Randomization. - Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results. - Any condition that is unstable and could jeopardize the subject's participation in the study. | |
| 83 | NCT00628810 | completed | 0 | phase 2 | ['colorectal cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['fluorouracil', 'irinotecan hydrochloride', 'leucovorin calcium'] | ['C1=C(C(=O)NC(=O)N1)F', 'CCC1=C2CN3C(=CC4=C(C3=O)COC(=O)C4(CC)O)C2=NC5=C1C=C(C=C5)OC(=O)N6CCC(CC6)N7CCCCC7.Cl', 'C1C(N(C2=C(N1)N=C(NC2=O)N)C=O)CNC3=CC=C(C=C3)C(=O)NC(CCC(=O)[O-])C(=O)[O-].[Ca+2]'] | DISEASE CHARACTERISTICS: - Diagnosis of metastatic adenocarcinoma of the colon or rectum - Not curable by surgery - Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/ UGT1A1*28 - Measurable disease - No original tumor in place - No secondary cerebral metastases PATIENT CHARACTERISTICS: Inclusion criteria: - WHO performance status 0-2 - Life expectancy ≥ 3 months - Absolute neutrophil count ≥ 1,500/mm3 - Platelet count ≥ 100,000/mm3 - Hemoglobin ≥ 9.0 g/dL - Total bilirubin ≤ 1.5 times normal - Alkaline phosphatase ≤ 2.5 times normal (5 times normal if liver involvement) - Not pregnant or nursing - Negative pregnancy test - Fertile patients of must use effective contraception Exclusion criteria: - Progressive gastrointestinal ulcer, hemorrhagic ulcer, or perforation in the past 6 months - Enteropathy or chronic diarrhea - Proteinuria > 500 mg/24 hours - Active cardiac disease - Uncontrolled hypertension - Myocardial infarction in the past 12 months - Angina - NYHA grade II-IV congestive heart disease - Severe arrhythmia even with treatment - Peripheral vascular disease ≥ grade II - Nonhealing wound, ulcer, or severe bone fracture - Hemorrhagic diatheses or coagulopathy - Severe or uncontrolled infection - Severe or uncontrolled medical condition - Other malignant disease in the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the uterine cervix - Severe traumatic injury within the past 4 weeks PRIOR CONCURRENT THERAPY: - No prior chemotherapy for metastatic disease - One prior regimen of chemotherapy in the neoadjuvant or adjuvant setting for the original tumor allowed - At least 6 months since prior chemotherapy - No prior irinotecan hydrochloride or bevacizumab - No oral or parenteral anticoagulant therapy within the past 10 days - Warfarin allowed provided INR < 1.5 - No major surgery or biopsy within the past 4 weeks - No puncture in the past 7 days - No planned major surgery - No concurrent daily or chronic aspirin (> 325 mg/day), anti-inflammatories, or steroids - No other concurrent anticancer therapy | |
| 84 | NCT00482430 | completed | 0 | phase 2 | ['paranoid schizophrenia', 'schizophrenia'] | ["['F20.0']", "['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['mk0557', 'comparator: placebo (unspecified)'] | ['C1CC2(CCC1C(=O)NC3=NN(C=C3)C4=CC=CC=C4F)C5=C(C=CN=C5)C(=O)O2'] | Inclusion Criteria: - Patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months - Patient has a 6th grade reading level or better and has completed at least 6 years of formal education - Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout study - Patient has had a stable living arrangement for at least 3 months prior to study start - Patient is in general good health based on screening assessments Exclusion Criteria: - Patient has a major disease/disorder that may interfere with cognitive testing (such as mental retardation) and/or pose a risk upon study participation - Patient has a history of head trauma with loss of consciousness greater than 15 minutes - Patient has had warfarin treatment, MAO inhibitors, clonazepam, clozapine or St. John's wort within 1 month of screening - Patient has had ECT treatment within 6 months of screening - Patient requires treatment with antihistamines or certain other medications listed in the protocol - Patient has a history of liver disease that has been active within the last 2 years, or a history of cancer within past 5 years - Patient has a history of alcohol or drug dependence within past year or alcohol or drug abuse within 3 months of screening | |
| 85 | NCT00141219 | completed | 1 | phase 3 | ['diabetic neuropathies', 'neuralgia'] | ["['G60.8']", "['G50.0', 'M54.81', 'B02.22', 'M79.2']"] | ['pregabalin', 'placebo'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - Diagnosis of peripheral neuropathic pain syndrome, including diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), or post-traumatic neuropathic pain (including post-surgical), confirmed by a qualified pain specialist. - Subjects must have completed at least 4 daily pain diaries during the 7 days prior to Visit 2 and have an average pain score of ≥4 over the 7 days prior to Visit 2 (randomization). Exclusion Criteria: - Neurologic disorders unrelated to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical), that may confuse or confound the assessment of neuropathic pain. - Presence of any severe pain associated with conditions other than DPN, PHN, or post-traumatic neuropathic pain (including post-surgical) that may confound the assessment or self evaluation of the pain due to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical). - Creatinine clearance < 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation in Appendix E). Maximum dose for subjects with creatinine clearance of 30 to 60 mL/min is 300 mg/day | |
| 86 | NCT00644358 | completed | 1 | phase 3 | ['major depressive disorder'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['vilazodone'] | ['C1CN(CCN1CCCCC2=CNC3=C2C=C(C=C3)C#N)C4=CC5=C(C=C4)OC(=C5)C(=O)N'] | Inclusion Criteria: - Males or females 18-70 years of age. - Meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder. - Hamilton Depression Rating Scale (HAM-D) score ≥ 18 on the first 17 items of the 21-item HAM-D at Screening and Baseline Visits. - Patients must have general ocular health. Exclusion Criteria: - Patients with a history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes). - Patients who meet DSM-IV-TR criteria for substance abuse or dependence within 1 year of the Baseline visit. - Patients who, in the Investigator's judgment, pose a serious suicidal or homicidal risk or have made a suicide attempt within 6 months prior to Screening Visit. - Patients who are taking psychotropic drugs. Patients who have taken psychotropic drugs must have discontinued these prior to Screening Visit. - Patients taking migraine medications with a serotonergic mechanism of action. - Patients taking Cytochrome P450 3A4 (CYP3A4) inhibitors such as grapefruit juice, ketoconazole, diltiazem, and macrolide antibiotics. - Patients with a known hypersensitivity to selective serotonin reuptake inhibitors (SSRIs) or 5-hydroxytryptamine 1a (5-HT1a) agonists. - Patients previously treated with vilazodone. - Patients taking Chantix or St. John's Wort. - Presence of significant acute or chronic medical disorders by history or physical exam. - Patients with a history of seizure disorders. - Prior history of malignancy if patient has <5 year survival OR completed treatment <1 year prior to enrollment and is currently without evidence of recurrence. - Skin cancers other than malignant melanoma will be permitted. - Patients with evidence of other central nervous system disorders including psychosis, delirium, dementia and amnesic disorders. - Patients with renal impairment or hepatic impairment. - Patients who are not euthyroid. - Patients with any serious medical or neurological disorder or condition that make it unlikely that the patient could complete one year of treatment or would otherwise preclude the administration of study medication. - Female patients must not be pregnant, not lactating, and not planning to become pregnant during the time of study participation. All female patients who are not at least 1 year post menopausal or irreversibly surgically sterilized must be using adequate and reliable contraception throughout the trial. - Patients with clinically significant ECG abnormalities which, as determined by the investigator, make it unlikely that the patient would complete one year of treatment or would otherwise preclude treatment with vilazodone. - Patients having clinically significant abnormal laboratory findings. - Patients with a positive drug screen. - Patients who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures. - Patients that have taken an investigational drug or participated in an investigational drug trial within the past 30 days. | |
| 87 | NCT00100828 | terminated | closed due to early stopping rule | 0 | phase 2 | ['head and neck cancer'] | ["['C76.0', 'C47.0', 'C49.0', 'C77.0', 'D17.0', 'D21.0', 'D36.11']"] | ['irinotecan hydrochloride'] | ['CCC1=C2CN3C(=CC4=C(C3=O)COC(=O)C4(CC)O)C2=NC5=C1C=C(C=C5)OC(=O)N6CCC(CC6)N7CCCCC7.Cl'] | Inclusion - Histologically confirmed medullary thyroid cancer - Metastatic or inoperable locoregional disease - Measurable disease by CT scan - 18 years and over - ECOG PS 0-1 Adequate lab functions including: - Granulocyte count > 1,000/mm^3 - Platelet count > 100,000/mm^3 - Bilirubin < 1.5 mg/dL - ALT and AST < 2.5 times upper limit of normal - No unstable or uncompensated hepatic disease - Creatinine clearance > 60 mL/min - No unstable or uncompensated renal disease - Negative pregnancy test - More than 3 months since prior biologic therapy - More than 3 months since prior chemotherapy - No prior radiotherapy to > 25% of bone marrow - More than 3 months since prior radiotherapy - Recovered from prior oncologic or other major surgery - More than 30 days since prior non-approved or investigational drugs Exclusion: - Patients with elevated calcitonin levels as the only measurement of disease are not eligible - Unstable or uncompensated cardiovascular disease - Unstable or uncompensated respiratory disease - Pregnant or nursing - Diarrhea ≥ grade 2 (antidiarrheals allowed) - Other severe or uncontrolled systemic disease - Other malignancy within the past 5 years except squamous cell or basal cell skin cancer or cervical cancer - Illness that would preclude study participation - Significant clinical disorder or laboratory finding that would preclude study participation |
| 88 | NCT01822899 | completed | 1 | phase 3 | ['pulmonary disease, chronic obstructive'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['umeclidinium bromide/vilanterol', 'placebo accuhaler/diskus', 'fluticasone propionate/salmeterol', 'placebo ndpi'] | ['Status: 400', 'Status: 400'] | Inclusion Criteria: - Type of subject: Outpatient - Informed Consent: A signed and dated written informed consent prior to study participation - Age: Subjects 40 years of age or older at Visit 1 - Gender: Male or female subjects. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile); or Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in the protocol used consistently and correctly - Diagnosis: established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society as follows: Chronic obstructive pulmonary disease is a preventable and treatable disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences. - Smoking history: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years [number of pack years = (number of cigarettes per day/20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar smoking cannot be used to calculate pack year history. - Severity of disease: A pre and post-salbutamol FEV1/FVC ratio of <0.70 and a post-salbutamol FEV1 of >=30% and <=70% of predicted normal values calculated using NHANES III reference equations at Visit 1. - Dyspnea: A score of >=2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Visit 1. Exclusion Criteria: - Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study - Asthma: A current diagnosis of asthma - Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject, who, in the opinion of the investigator, has any other significant respiratory condition in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease. Inactive tuberculosis in more than one lobe is exclusionary. Allergic rhinitis is not exclusionary. - Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. - Contraindications: A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, corticosteroid, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic. - Hospitalization: Hospitalization for pneumonia within 12 weeks prior to Visit 1 - History of COPD Exacerbation: A documented history of at least one COPD exacerbation in the 12 months prior to Visit 1 that required either oral corticosteroids, antibiotics, and/or hospitalization. Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence. - Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1) - 12-Lead ECG: An abnormal and significant electrocardiogram (ECG) finding from the 12-lead ECG conducted at Visit 1. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. - Medication Prior to Spirometry: Unable to withhold salbutamol for the 4 hour period required prior to spirometry testing at each study visit. - Medications Prior to Screening: Use of the following medications according to the following defined time intervals prior to Visit 1: Depot corticosteroids - 12 weeks, Systemic, oral or parenteral corticosteroids - 6 weeks, Antibiotics (for lower respiratory tract infection) - 6 weeks, Cytochrome P450 3A4 strong inhibitors - 6 weeks, Herbal medications potentially containing oral or systemic steroids - 6 weeks, Inhaled corticosteroids (ICS) - 30 days, Long-acting beta2-agonist (LABA)/ICS combination products - 30 days, Phosphodiesterase 4 (PDE4) inhibitors (e.g., roflumilast) - 14 days, Inhaled long-acting anticholinergics - 7 days, Theophyllines - 48 hours, Oral leukotriene inhibitors (zafirlukast, montelukast, zileuton) - 48 hours, Oral beta2-agonists Long-acting-48 hours/Short-acting - 12 hours, Inhaled long acting beta2-agonists (LABA, e.g., salmeterol, formoterol, indacaterol) - 48 hours, Inhaled sodium cromoglycate or nedocromil sodium - 24 hours, Inhaled short acting beta2-agonists - 4 hours, Inhaled short-acting anticholinergics - 4 hours, Inhaled short-acting anticholinergic/short-acting beta2-agonist combination products - 4 hours, Any other investigational medication - 30 days or within 5 drug half-lives (whichever is longer) - Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., <=12 hours per day) is not exclusionary. - Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., salbutamol) via nebulized therapy. - Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded. - Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1. - Affiliation with Investigator Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator - Inability to read: A subject will not be eligible for the study if in the opinion of the investigator the subject cannot read. | |
| 89 | NCT01186770 | completed | 1 | phase 3 | ['opioid-induced constipation'] | ["['F11.14', 'F11.181', 'F11.182', 'F11.188', 'F11.19', 'F11.24', 'F11.281']"] | ['methylnaltrexone', 'placebo'] | ['C[N+]1(CCC23C4C(=O)CCC2(C1CC5=C3C(=C(C=C5)O)O4)O)CC6CC6'] | Key Inclusion Criteria: 1. History of chronic non-malignant pain (originating from a non-malignant source) with condition(s) underlying the chronic pain of greater than or equal to (≥) 2 months' duration before the screening visit. 2. Taking oral, transdermal, intravenous (IV), or subcutaneous (SC) opioids for chronic non-malignant pain for ≥1 month. 3. No known history of chronic constipation prior to the initiation of opioid therapy. 4. Currently taking laxative therapy for ≥30 days and willing to discontinue all laxative therapy at the start of screening period and use only study-permitted rescue laxatives throughout the screening and double-blind treatment periods.. Key Exclusion Criteria: 1. Prior treatment with oral MNTX. 2. Prior treatment with SC MNTX within 30 days of screening. 3. Women who are pregnant, breastfeeding, or plan to become pregnant during the study. 4. Fecal incontinence, rectal prolapse, fecal ostomy or other clinically significant gastrointestinal disorders such as inflammatory bowel disease or clinically significant irritable bowel syndrome that would have made bowel movement assessment inaccurate. 5. Current treatment with partial opioid agonists (for example; buprenorphine) or combination agonists/antagonists. | |
| 90 | NCT00518986 | completed | 1 | phase 4 | ['sleep disorders', 'obstructive sleep apnea', 'major depressive disorder', 'dysthymic disorder'] | ["['G47.9', 'G47.21', 'G47.22', 'G47.23', 'G47.52', 'G47.29', 'G47.20']", "['G47.33', 'P28.32']", "['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']", "['F34.1']"] | ['armodafinil', 'placebo'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - Current diagnosis of obstructive sleep apnea/hypopnea syndrome (OSAHS) - Complaint of residual excessive sleepiness despite nasal continuous positive airway pressure (nCPAP) therapy being effective - Current or prior diagnosis of major depressive disorder or dysthymic disorder - Clinically stable with regard to depressed mood and has shown a treatment response to selective serotonin reuptake inhibitor (SSRI) therapy or serotonin and norepinephrine reuptake inhibitor (SNRI) therapy - Patient has been on a stable monotherapy dose of an allowed SSRI or SNRI for at least 8 weeks at the time of screening - Women of childbearing potential must use a medically accepted method of contraception. Exclusion Criteria: - Confirmed or suspected diagnosis of a currently active sleep disorder other than obstructive sleep apnea/hypopnea syndrome (OSAHS) - Current episode of major depression that is considered to be treatment-resistant - A primary diagnosis of: eating disorder, psychotic disorder, delirium, dementia, substance-related disorders, or moderate to severe hypochondriasis - Patient has a history of bipolar disorder, psychotic depression, schizophrenia, schizoaffective disorder, any other psychotic disorder, or other clinically significant uncontrolled psychiatric condition. - Patient has a history of homicidal ideation or significant aggression - Patient has a diagnosis of severe antisocial or borderline personality disorder - Has a history of significant suicidal ideation, or has current active suicidal ideation, or is considered at imminent risk of self harm. - Patient has a history consistent with fibromyalgia or chronic fatigue syndrome - A high consumption of caffeinated products, approximately equivalent to 5 or more cups of coffee per day - Patient history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction - Has a past or present seizure disorder - Patient has a history of alcohol, narcotic, or any other substance abuse or dependence (with the exception of nicotine) - Psychotherapeutic intervention for the patient was initiated within 8 weeks of the screening visit. - Patient has known human immunodeficiency virus (HIV) - Patient has any clinically significant uncontrolled medical condition (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition (treated or untreated) - Patient is a pregnant or lactating woman - Patient has previously received armodafinil; or, patient has used modafinil or any investigational product within 28 days of the baseline visit. | |
| 91 | NCT00735709 | completed | 1 | phase 3 | ['major depressive disorder'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['vortioxetine', 'placebo'] | ['CC1=CC(=C(C=C1)SC2=CC=CC=C2N3CCNCC3)C'] | Inclusion Criteria: - Has a primary diagnosis of major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. - The reported duration of the current major depressive episode is at least 3 months. - Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥26. - A male or a female of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication. Exclusion Criteria: - Has 1 or more the following: - Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR. - Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR. - Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. (must have negative urine drug screen prior to Baseline). - Presence or history of a clinically significant neurological disorder (including epilepsy). - Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc). - Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale, or has made a suicide attempt in the previous 6 months. - Currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study. - Has a clinically significant unstable illness. - Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors. - Has received electroconvulsive therapy within 6 months prior to Screening. - Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level > 1.5 times the upper limit of normal. - Has a serum creatinine of > 1.5 × upper limit of normal. - Has a previous history of cancer that had been in remission for less than 5 years. - Has thyroid stimulating hormone value outside the normal range. - Has an abnormal electrocardiogram. | |
| 92 | NCT00062257 | completed | 0 | phase 2 | ['gastric cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['irofulven'] | ['CC1=C(C2=C(C3(CC3)C(C(=O)C2=C1)(C)O)C)CO'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed gastric adenocarcinoma - Recurrent or metastatic disease - Adenocarcinoma of the gastroesophageal junction eligible provided the majority of tumor bulk is below the junction - Measurable disease - At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - No known brain metastases PATIENT CHARACTERISTICS: Age - Over 18 Performance status - ECOG 0-2 Life expectancy - More than 3 months Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No active disseminated intravascular coagulation Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST/ALT no greater than 2.5 times ULN (5 times ULN for patients with liver metastases) - Alkaline phosphatase no greater than 5 times ULN Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reaction attributed to compounds of similar chemical or biological composition to irofulven - No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer - No other uncontrolled concurrent illness that would preclude study participation - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - Must have central or peripherally inserted central catheter PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa Chemotherapy - No prior chemotherapy for recurrent or metastatic disease - Prior adjuvant or neoadjuvant chemotherapy allowed provided disease relapsed more than 6 months after therapy Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy and recovered Surgery - Not specified Other - No other concurrent investigational or commercial agents or therapies for the malignancy - No concurrent combination antiretroviral therapy for HIV-positive patients | |
| 93 | NCT01040793 | completed | 1 | phase 3 | ['pulmonary disease, chronic obstructive'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['olodaterol (bi 1744)', 'olodaterol (bi 1744)', 'placebo', 'olodaterol (bi1744)', 'olodaterol (bi 1744) placebo'] | ['CC(C)(CC1=CC=C(C=C1)OC)NCC(C2=C3C(=CC(=C2)O)NC(=O)CO3)O', 'CC(C)(CC1=CC=C(C=C1)OC)NCC(C2=C3C(=CC(=C2)O)NC(=O)CO3)O', 'Status: 503'] | Inclusion criteria: 1. Signed informed consent prior to participation. 2. Diagnosis of chronic obstructive pulmonary disease and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec) <80% of predicted normal and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec)/FVC of < 70% at Visit 1. 3. Male or female between 40 and 75 years of age. 4. Current or ex-smokers with smoking history of more than 10-pack years. 5. Able to perform technically acceptable pulmonary function tests, multiple exercise tests and able to maintain records. 6. Able to inhale medication in a competent manner from a metered-dose inhaler and Respimat inhaler. Exclusion criteria: 1. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN. 2. Patients with a history of asthma and/or total blood eosinophil count of 600 cells/mm3. 3. Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute). 4. Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse or contraindications to exercise. 5. Patients who have undergone thoracotomy with pulmonary resection. 6. Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day. 7. Patients who regularly use daytime oxygen for more than one hour per day. 8. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program. 9. Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea. 10. Pregnant or nursing women. 11. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier). | |
| 94 | NCT00239980 | completed | 0 | phase 2 | ['ovarian cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['dalteparin'] | ['CC(=O)NC1C(C(C(OC1O)COS(=O)(=O)O)OC2C(C(C(C(O2)C(=O)O)OC3C(C(C(C(O3)CO)OC4C(C(C(C(O4)C(=O)O)O)O)OS(=O)(=O)O)OS(=O)(=O)O)NS(=O)(=O)O)O)OS(=O)(=O)O)O'] | Inclusion Criteria: Patients must meet all of the following criteria to be considered for enrolment: - Women with newly diagnosed, histologically proven EOC are potentially eligible. Patients with primary peritoneal or fallopian tube tumours of equivalent histology are also considered for enrolment. If open or true cut biopsy is not available, fine needle aspiration (FNA) showing an adenocarcinoma is considered diagnostic for EOC if all 4 (a to d) of the following conditions are satisfied: 1. Patient has a pelvic mass, AND 2. Any evidence of disease larger than 1 cm in the upper abdomen (unless proven stage IV), AND 3. Normal mammography within 6 weeks of randomization, AND 4. Serum CA-125/CEA greater than or equal to 25. If the ratio is less than 25, a barium enema (or colonoscopy) and gastroscopy (or radiological examination of the stomach) must be negative for a primary tumour. - Between the ages of 18 and 75. - FIGO stage IIB to IV disease. - A pre-study CA-125 level at least twice the upper limit of normal. - Eligible for standard adjuvant treatment with taxane- and platinum-based chemotherapy by meeting all of the following laboratory findings within 7 days prior to randomization: 1. Absolute granulocyte count of at least 1.5 x 10 9/L (1500 per cubic millimetre). 2. Platelet count of at least 150 x 109/L (100,000 per cubic millimetre). 3. Serum creatinine no greater than 177 micromol/L (2.0 mg/dL). 4. Total bilirubin level no greater than 1.5 times the upper limit of normal at the local centre. 5. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) levels no greater than 3 times the upper limit of normal of the local centre. Exclusion Criteria: - Borderline ovarian tumours. - Received prior chemotherapy or radiation therapy for EOC. - Received mouse antibodies anytime during the 28 days prior to the pre-study CA-125 level. - History of another malignancy, unless disease-free for 5 years or greater; non-melanomatous skin carcinoma or curatively treated carcinoma-in-situ of the cervix are excepted. - Eastern Cooperative Oncology Group (ECOG) performance score of 3 or 4. - Life expectancy less than 12 weeks. - Complete bowel obstruction at the time of study enrolment. - Receiving long-term anticoagulant therapy for an established indication (e.g., atrial fibrillation, mechanical heart valves). - Bleeding diathesis (e.g., evidence of DIC, hereditary or acquired bleeding disorder). - History of allergy to any heparin (e.g., heparin-induced thrombocytopenia). - Significant cardiac history including myocardial infarction within preceding 6 months, congestive heart failure, clinically relevant atrial or ventricular arrhythmias, history of 2nd or 3rd degree heart blocks unless pacemaker is implanted. - Serious medical conditions that preclude the administration of chemotherapy, anticoagulant therapy, or adherence to protocol, including but not exclusive to: 1. Allergic reactions to drugs containing cremophor or compounds chemically related to taxanes or platinum analogues. 2. Significant neurologic or psychiatric disorder that would impair obtaining informed consent and reliable follow-up. 3. Uncontrolled hypertension despite optimal medical therapy. 4. Active, uncontrolled infection. - Women who are pregnant or lactating or are of childbearing potential but are not using effective contraception. - Total body weight of less than 40 kg. - Concurrent treatment with experimental or investigational drugs. - Unable or unwilling to attend scheduled follow-ups. - Unable (e.g., language barrier, mental illness) to provide informed consent. | |
| 95 | NCT00256204 | completed | 1 | phase 3 | ["parkinson's disease"] | ["['G20']"] | ['rasagiline mesylate', 'rasagiline mesylate'] | ['CS(=O)(=O)O.C#CCNC1CCC2=CC=CC=C12', 'CS(=O)(=O)O.C#CCNC1CCC2=CC=CC=C12'] | Inclusion Criteria: - Men and women with idiopathic PD whose diagnosis is confirmed at screening, with at least two cardinal signs without any other known or suspected cause of parkinsonism. If tremor is not present, subjects must have unilateral onset and persistent asymmetry. - Subjects with a diagnosis of early idiopathic PD of less than 1½ years duration from time of documented diagnosis. - Subjects whose clinical condition at the time of enrollment does not require anti-PD treatment and will not require for the next 9 months. - Willing and able to give informed consent. Exclusion Criteria: - Subjects younger than 30 or older than 80 years. - Subjects with loss of postural reflexes. - Subjects with UPDRS Tremor score of 3 or greater in any limb. - Subjects with Hoehn &Yahr Stage III or greater at screening. - Subjects with freezing while walking. - Subjects with any of the following features that tend to exclude PD as the cause of Parkinsonism: - History of repeated strokes with stepwise progression of Parkinsonian features - History of repeated head injury or history of definite encephalitis - Sustained remission - Supranuclear gaze palsy - Cerebellar signs - Early severe autonomic involvement - Babinski's sign - Presence of a cerebral tumour or communicating hydrocephalus - MPTP exposure - Oculogyric crises - Subjects who have had previous use of rasagiline or selegiline - Subjects having used other anti-PD medication basis at any time prior to baseline - Subjects having used other anti-PD medication (including anticholinergics) for less than 3 weeks during the 3 month period prior to baseline. (not including a single L-Dopa dose as part of L-Dopa test) - Subjects having used any other anti-PD medication (including anticholinergics) for less than 3 weeks prior to the 3 month period preceding baseline whose anti-PD medication is intentionally ceased in order for the subject to enter the study. - Subjects who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete participation - Hypertensive subjects whose BP is not well controlled according to the medical record or as observed during the week of home BP recording prior to baseline - Subjects diagnosed with melanoma based on the screening dermatologic examination, or with a history of melanoma. Subjects with suspicious lesions at baseline who do not undergo biopsy - Subjects with significant cognitive impairment as defined by MMSE score < 26 - Subjects with clinically significant psychiatric illness, including major depression [Beck Depression Inventory (short form) ≥15 - Subjects with a history of alcohol or substance abuse within the past 2 years - Subjects who have taken any experimental medications within 60 days prior to baseline - Subjects who have used coenzyme Q10 (in daily doses > 300 mg) within 120 days prior to baseline - Subjects who have used sympathomimetics (including over-the-counter remedies - nasal or oral), dextromethorphan, pethidine or St. John's Wort within the 7 days prior to baseline - Subjects who have used antidepressants within 42 days prior to baseline - Subjects who have used ciprofloxacin, a potent CYP 1A2 inhibitor within 7 days prior to baseline - Subjects who have used MAO inhibitors including reserpine or methyldopa within the three months prior to baseline, or treatment with an anti-emetic or antipsychotic medication with central dopamine antagonist activity within the six months prior to baseline - Women who are not postmenopausal, surgically sterilized, or using adequate birth control [oral birth control pills, IUD, or a long acting injectable form of contraception; barrier methods alone (i.e., condom) are not sufficient]. Women of childbearing potential without a negative pregnancy test at screening. Nursing women | |
| 96 | NCT00297310 | completed | 1 | phase 4 | ['kidney transplantation', 'transplantation'] | ["['N26.2', 'Q63.0', 'Q63.2', 'Z52.4', 'I75.81', 'N19', 'N20.0']"] | ['tacrolimus'] | ['CC1CC(C2C(CC(C(O2)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C(CC(=O)C(C=C(C1)C)CC=C)O)C)C(=CC4CCC(C(C4)OC)O)C)O)C)OC)OC'] | Inclusion Criteria: - Patient has end-stage kidney disease and is a suitable candidate for primary renal transplantation or re-transplantation - Patient is receiving a kidney transplant from a cadaveric or living (not HLA identical) donor, at least 10 years of age, with compatible ABO blood type Exclusion Criteria: - Patients receiving a graft from a non-heart-beating donor - known to have significant liver disease, or is receiving a graft from a hepatitis C or B positive donor - previously received or is receiving an organ transplant other than a kidney - taking diltiazem, or any of the other disallowed medications during the 7 days prior to, and the 30 day trial period, or has been taking an investigational drug in the past 28 days - patient or donor known to be HIV positive | |
| 97 | NCT00101283 | completed | 0 | phase 2 | ['mesothelioma'] | ["['C45.9', 'C45.0', 'C45.1', 'C45.2', 'C45.7']"] | ['pemetrexed disodium', 'gemcitabine hydrochloride', 'carboplatin'] | ['C1=CC(=CC=C1CCC2=CNC3=C2C(=O)NC(=N3)N)C(=O)NC(CCC(=O)[O-])C(=O)[O-].[Na+].[Na+]', 'C1=CN(C(=O)N=C1N)C2C(C(C(O2)CO)O)(F)F.Cl', 'C1CC(C1)(C(=O)O)C(=O)O.[NH2-].[NH2-].[Pt+2]'] | Inclusion Criteria: - Histologically or cytologically confirmed advanced mesothelioma of the pleura - Measurable disease, as defined by RECIST criteria, within 4 weeks of randomization. Patients with pleural rinds not measurable by RECIST were eligible if disease was evaluable within 4 weeks of randomization using mesothelioma response criteria - May have undergone pleurodesis. If pleurodesis was performed, there must have been at least a 2-week delay before Pemetrexed administration. A CT must have been performed after 2 weeks after pleurodesis to serve as the baseline scan. - ECOG Performance Status of 0 or 1 - Normal organ and marrow function, as defined by: - Absolute neutrophil count ≥ 1,500/ul - Platelet count ≥ 100,000/ul - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement) - Albumin ≥ 2.5 g/dL - Creatinine clearance ≥ 45 mL/min or Creatinine ≤ 2.0 g/dL - Age 18 years and over - Able to take folic acid and cyanocobalamin (vitamin B12) - Willing and able to take dexamethasone - Women of childbearing potential and sexually active men were required to use contraception during and for the first 3 months after the study Exclusion Criteria - A candidate for curative surgery - Prior radiation therapy to the target lesion, unless the lesion was clearly progressing per RECIST criteria after prior radiation and the interval between the most recent radiation therapy and enrollment was at least 4 weeks - Prior systemic chemotherapy for mesothelioma. Prior intracavitary cytotoxic drugs or immunomodulators were not permitted, unless given for the purpose of pleurodesis. - Active infection or serious concomitant systemic disorder - Second primary malignancy, other than in situ malignancies or adequately treated basal cell carcinoma of the skin or other malignancy treated at least 3 years previously with no evidence of recurrence. - Treatment with an investigational agent within 4 weeks before enrollment - Known or suspected brain metastases - Women must not be pregnant or breastfeeding - Obviously malnourished or with a weight loss of greater than 10% in the preceding 6 weeks - Aspirin or other nonsteroidal anti-inflammatory drugs for 2 days before, during, and for 2 days after each administration of pemetrexed disodium (5 days before, during, and 2 days after each administration of pemetrexed disodium for piroxicam, naproxen, diflunisal, or nabumetone) | |
| 98 | NCT00300443 | completed | 1 | phase 2/phase 3 | ['ocular hypertension'] | ["['H40.053', 'H40.051', 'H40.052', 'H40.059']"] | ['bimatoprost'] | ['CCNC(=O)CCCC=CCC1C(CC(C1C=CC(CCC2=CC=CC=C2)O)O)O'] | Inclusion Criteria: - Clinical diagnosis of glaucoma or ocular hypertension in both eyes - Patient requires IOP-lowering drug in both eyes Exclusion Criteria: - Uncontrolled medical conditions - Ocular seasonal allergies within the past 2 years | |
| 99 | NCT01189890 | completed | 1 | phase 3 | ['type 2 diabetes mellitus'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['sitagliptin phosphate', 'glimepiride', 'placebo to sitagliptin', 'placebo to glimepiride'] | ['Status: 503', 'Status: 503', 'Status: 503', 'Status: 503'] | Inclusion Criteria - Diagnosis of type 2 diabetes mellitus Exclusion Criteria - History of type 1 diabetes mellitus - Has undergone a surgical procedure within the prior 4 weeks. - Current participation in, or has participated, in another study with an investigational device or compound, with the prior 12 weeks, and/or is not willing to refrain from participating in any other study while participating in this study - Hypersensitivity or contraindication to any sulfonylurea (e.g., glimepiride) medication - Has been on an investigational or approved dipeptidyl peptidase-4 (DPP-4) inhibitor agent (e.g., sitagliptin, saxagliptin) - Presence of human immunodeficiency virus (HIV) - Current participation in a weight loss program or is receiving weight loss medication - History of blood disorder, certain cancers, heart, liver or kidney disease - Current or past use of recreational or illicit drugs, or a history of drug abuse or dependence, or increased alcohol consumption | |
| 100 | NCT01045707 | completed | 1 | phase 3 | ['diabetes', 'diabetes mellitus, type 2'] | ["['E23.2', 'N25.1', 'P70.2', 'O24.92', 'Z83.3', 'Z86.32', 'E10.65']", "['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['insulin degludec/insulin aspart', 'insulin glargine'] | ['Status: 400', 'CCC(C)C1C(=O)NC2CSSCC(C(=O)NC(CSSCC(C(=O)NCC(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(CSSCC(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC2=O)CO)CC(C)C)CC3=CC=C(C=C3)O)CCC(=O)N)CC(C)C)CCC(=O)O)CC(=O)N)CC4=CC=C(C=C4)O)C(=O)NCC(=O)O)C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CC5=CC=CC=C5)C(=O)NC(CC6=CC=CC=C6)C(=O)NC(CC7=CC=C(C=C7)O)C(=O)NC(C(C)O)C(=O)N8CCCC8C(=O)NC(CCCCN)C(=O)NC(C(C)O)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)C)CC(C)C)CC9=CC=C(C=C9)O)CC(C)C)C)CCC(=O)O)C(C)C)CC(C)C)CC2=CNC=N2)CO)NC(=O)C(CC(C)C)NC(=O)C(CC2=CNC=N2)NC(=O)C(CCC(=O)N)NC(=O)C(CC(=O)N)NC(=O)C(C(C)C)NC(=O)C(CC2=CC=CC=C2)N)C(=O)NC(C(=O)NC(C(=O)N1)CO)C(C)O)NC(=O)C(CCC(=O)N)NC(=O)C(CCC(=O)O)NC(=O)C(C(C)C)NC(=O)C(C(C)CC)NC(=O)CN'] | Inclusion Criteria: - For MAIN period (NN5401-3590): - Diagnosis of type 2 diabetes mellitus for at least 6 months - Insulin naïve subjects - Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start - Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive) - Body Mass Index (BMI) no higher than 40.0 kg/m^2 - For EXTENSION period (NN5401-3726): - Informed consent obtained before any trial-related activities - Must have completed the 26-week treatment period (visit 28) in trial NN5401-3590 Exclusion Criteria: - For MAIN period (NN5401-3590): - Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start - Cardiovascular disease diagnosed within 6 months before trial start - For EXTENSION period (NN5401-3726): - Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, Monoamine oxidase (MAO) inhibitors - Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician) - Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements |