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| # | nctid | status | why_stop | label | phase | diseases | icdcodes | drugs | smiless | criteria |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01059539 | completed | 1 | phase 3 | ['bipolar i disorder'] | ["['F31.70', 'F31.71', 'F31.72', 'F31.73', 'F31.74', 'F31.75', 'F31.76']"] | ['cariprazine'] | ['Status: 503'] | Inclusion Criteria: - Patients who have provided informed consent prior to any study specific procedures. - Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID). - Patients who experienced a manic or mixed episode that required treatment within the past 12 months. - Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG). Exclusion Criteria: - Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder. | |
| 2 | NCT00709449 | completed | 1 | phase 2/phase 3 | ['macular degeneration', 'glaucoma', 'regional blood flow'] | ["['H35.30', 'H35.353', 'H35.351', 'H35.352', 'H35.359', 'H35.3130', 'H35.3230']", "['H40.9', 'Q15.0', 'B73.02', 'H40.823', 'H40.89', 'H44.513', 'H40.821']"] | ['moxaverine', 'moxaverine', 'moxaverine'] | ['CCC1=NC(=C2C=C(C(=CC2=C1)OC)OC)CC3=CC=CC=C3', 'CCC1=NC(=C2C=C(C(=CC2=C1)OC)OC)CC3=CC=CC=C3', 'CCC1=NC(=C2C=C(C(=CC2=C1)OC)OC)CC3=CC=CC=C3'] | Inclusion Criteria: - Men and women aged over 50 years - Ametropia of less than 6 diopters and anisometropia of less than 2 diopters - Clear non-lenticular ocular media AMD patients: - Patients with nonexudative AMD - Visual acuity in the study eye > 20/60 Glaucoma patients: - Unilateral or bilateral primary open angle glaucoma - At least 3 reliable visual field testings - Treated intraocular pressure < 21 mmHg, - Visual field mean deviation MD <10 (Humphrey 30-2) Healthy control subjects: - Age- , gender- and sex- matched to the two patient groups, - Matched with regard to smoking habits of the two patient group - No observable eye diseases Exclusion Criteria: - History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of the study drug - Blood donation during the previous 3 weeks - Abuse of alcoholic beverages or drugs, participation in a clinical trial in the 3 weeks preceding the study - Known diabetes mellitus - Presence of any ocular pathology that interferes with the aims of the present study - Intraocular surgery within the last 3 weeks - Hypersensitivity to moxaverine - Acute gastric bleeding, massive cerebral hemorrhage related to stroke | |
| 3 | NCT00294255 | completed | 1 | phase 4 | ['bipolar disorder'] | ["['F31.81', 'F31.89', 'F31.9', 'F25.0', 'F31.0', 'F31.31', 'F31.32']"] | ['risperidone'] | ['CC1=C(C(=O)N2CCCCC2=N1)CCN3CCC(CC3)C4=NOC5=C4C=CC(=C5)F'] | Inclusion Criteria: - DSM IV diagnosis of bipolar disorder, currently manic, or mixed manic - YMRS score>/= 16 - One or more of following: 1. 3 MADRS depression items scoring >/=3 2. 3 BISS depression items scoring >/=3 3. YMRS irritability and aggressive items sum score>/=4 - Taking lithium, valproate or lamotrigine at stable dose for 4 wks or longer, with adequate serum level - age 18 and over - Male or female - Inpatient or outpatient Exclusion Criteria: - | |
| 4 | NCT01020799 | completed | 0 | phase 2 | ['major depressive disorder'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['azd7268', 'escitalopram', 'placebo capsules', 'placebo tablets'] | ['CN(CCO)C(=O)C1=CC=C(C=C1)C(=C2CCN(CC2)CC3=CSC=N3)C4=CC=CC5=C4N=CC=C5', 'Status: 503'] | Inclusion Criteria: - Provision of signed, written, and dated Informed Consent prior to any study specific procedures - Documented primary clinical diagnosis meeting criteria from the DSM-IV, Text Revision (APA 2000) for any of the following: - 296.2x Major Depressive Disorder, Single Episode, or - 296.3x Major Depressive Disorder, Recurrent Exclusion Criteria: - Patients with a secondary DSM-IV Axis I disorder other than GAD or social anxiety disorder (as assessed by MINI), provided the primary diagnosis is MDD. This diagnosis should have been made at least 6 months before enrollment - 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 started less than 4 weeks before enrollment | |
| 5 | NCT00707031 | completed | 1 | phase 3 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['lixisenatide (ave0010)', 'exenatide', 'metformin'] | ['CCC(C)C(C(=O)NC(CCC(=O)O)C(=O)NC(CC1=CNC2=CC=CC=C21)C(=O)NC(CC(C)C)C(=O)NC(CCCCN)C(=O)NC(CC(=O)N)C(=O)NCC(=O)NCC(=O)N3CCCC3C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N4CCCC4C(=O)N5CCCC5C(=O)N6CCCC6C(=O)NC(CO)C(=O)N)NC(=O)C(CC7=CC=CC=C7)NC(=O)C(CC(C)C)NC(=O)C(CCCNC(=N)N)NC(=O)C(C(C)C)NC(=O)C(C)NC(=O)C(CCC(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CCSC)NC(=O)C(CCC(=O)N)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(CC(C)C)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CC8=CC=CC=C8)NC(=O)C(C(C)O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)CNC(=O)C(CC9=CNC=N9)N', 'CN(C)C(=N)N=C(N)N'] | Inclusion Criteria: - Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with metformin at a stable dose of at least 1.5 gram per day for at least 3 months prior to screening visit Exclusion Criteria: - HbA1c less than (<) 7% or greater than (>) 10% at screening - At the time of screening age < legal age of majority - Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method - Type 1 diabetes mellitus - Treatment with another antidiabetic pharmacological agent than metformin within the 3 months preceding the screening - FPG at screening >250 milligram per deciliter (mg/dL) (13.9 millimole per liter [mmol/L]) - Body mass index (BMI) less than or equal to (<=) 20 kilogram per square meter (kg/m^2) - Weight change of >5 kg during the 3 months preceding the study - History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease - History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening - Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to the time of screening - Within the last 6 months prior to screening, history of myocardial infarction, stroke, or heart failure requiring hospitalization - Known history of drug or alcohol abuse within 6 months prior to the time of screening - Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period - Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure or diastolic blood pressure >180 millimeter of mercury (mmHg) or >95 mmHg, respectively - Laboratory findings at the time of screening: aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase: >2 times upper limit of the normal (ULN) laboratory range; amylase and/or lipase: >3 times ULN; total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome); hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3) and/or platelets <100 000/ mm^3; positive test for Hepatitis B surface antigen and/or Hepatitis C antibody; and positive serum pregnancy test in females of childbearing potential - Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram or vital signs at the time of screening that, in the judgment of the investigator or any sub-investigator, precludes safe completion of the study or constrains efficacy assessment - Patients who are considered by the investigator or any sub-investigator as inappropriate for this study for any reason (for example, impossibility to meet specific protocol requirements, such as attending scheduled visits, being able to do self-injections; likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol; investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol) - Use of other oral or injectable antidiabetic or hypoglycemic agents than metformin (for example, sulfonylurea, alpha-glucosidase inhibitor, thiazolidinedione, rimonabant, exenatide, dipeptidyl-peptidase-4 inhibitors, insulin) within 3 months prior to the time of screening - Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening - Use of any investigational drug within 3 months prior to study - Participation in any previous study with lixisenatide - Renal impairment defined with serum creatinine >1.4 mg/dL in women and serum creatinine >1.5 mg/dL in men - Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to, gastroparesis and gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening - Allergic reaction to any glucagon like peptide-1 (GLP-1) agonist in the past (for example, exenatide, liraglutide) or to metacresol | |
| 6 | NCT00573950 | unknown status | 1 | phase 4 | ['diabetes mellitus, type 2', 'metabolic syndrome x'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']", "['E88.81', 'G93.41', 'E87.21', 'E87.22', 'E88.9', 'P19.9', 'E88.89']"] | ['cilostazol', 'placebo'] | ['C1CCC(CC1)N2C(=NN=N2)CCCCOC3=CC4=C(C=C3)NC(=O)CC4'] | - Eligible for study: 18 year and above, Gender eligible for study: both Inclusion Criteria:Type 2 diabetes patients with metabolic syndrome criteria of Asian-Pacific ATP III guideline - Type 2 diabetes (at least 1 criteria below) 1. fasting blood glucose ≥ 126 mg/dL 2. postprandial 2hour glucose ≥ 200 mg/dL 3. random blood glucose ≥ 200 mg/dL with typical diabetes symptoms - Metabolic syndrome : Asian-Pacific ATP III guideline 1. Fasting blood glucose ≥ 110 mg/dL, or previously diagnosed type 2 diabetes 2. systolic and/or diastolic blood pressure ≥130/85 mmHg, or treatment of previously diagnosed hypertension 3. Triglyceride ≥ 150 mg/dL, or Specific treatment for this lipid abnormality 4. HDL-cholesterol < 40 mg/dL for men and < 50 mg/dL for women, or Specific treatment for this lipid abnormality 5. Waist circumference ≥ 90 for men and ≥ 80 for women Exclusion Criteria: - Hypertensive patients with the use of ACE inhibitor or ARB - Hyperlipidemic patients with the use of statin or fenofibrate - Hepatic dysfunction - Chronic alcohol or drug abuse - Renal dysfunction - Heart failure - Patients who takes hormone replace therapy or steroid containing drugs - Patients who take drugs like anticoagulant (warfarin), anti-platelet agent (aspirin, ticlopidin), thrombolytic agent (urikinase, alteplase), prostaglandine E1 , drugs inhibit CYP3A4 or CYP2C19, or drugs become substrate of CYP3A4 - Patients who haves disease influencing the results of the study such as neurologic, digestive and neoplastic disease | |
| 7 | NCT00448097 | terminated | lack of patient population - slow accrual | 0 | phase 2 | ['prostatic neoplasms'] | ["['B38.81', 'N42.31', 'Z87.430', 'N40.0', 'N40.1']"] | ['cetuximab', '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'] | Inclusion Criteria: - Histologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage T1c or T2a with high grade disease (Gleason's 8-10) on initial biopsy, or clinical stage T2b-T2c with Gleason's grade 7 or above with a PSA ≥ 10ng/ml, or clinical stage T3. - Recent (< 6 weeks prior to study entry) negative bone scan and MRI of abdomen and pelvis. - Appropriate surgical candidate for radical prostatectomy and a performance status of < 2 (Zubrod scale). - Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count > 1,500 and platelet count of > 100,000, adequate hepatic function with a bilirubin < 1.5 mg % and SGPT < 2.5x the upper limits of normal, adequate renal function defined as serum creatinine < 1.5 x ULN. - Patients must have normal coagulation profile (PT, PTT) and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to local use only (for control of central line patency). - Patients must have no history of congestive heart failure or previous MI within the last 12 months. Exclusion Criteria: - Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational status drug. - Unable to tolerate transrectal ultrasound. - Patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing causes of death. Patients with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorder are not eligible. Patients with uncontrolled and symptomatic orthostatic hypotension or uncontrolled hypertension are not eligible. - Patients who are HIV positive or have chronic hepatitis B or C infections are not eligible. - Patients on oral steroid medications are not eligible. - Patients with significant arteriosclerotic disease, as defined by a previous arterial bypass claudication limiting activity, or a history of cerebrovascular events within the last year (including TIA) are not eligible. - Prior severe infusion reaction to a monoclonal antibody. |
| 8 | NCT00189839 | completed | 1 | phase 3 | ['kidney 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: - Patients receiving a kidney transplant from a cadaveric donor or a living non HLA identical donor between 5 and 65 years of age with compatible ABO blood type. - Patients with end stage kidney disease who are suitable candidates for primary renal transplantation or re-transplantation (unless the graft was lost because of immunological reasons within 12 months). Exclusion Criteria: - Patients receiving or having previously received an organ transplant other than a kidney. - Patients with a high immunological risk, defined as a panel reactive antibodies (PRA) grade >50% in the previous 6 months and/or with a previous graft survival of less than 12 months due to immunological reasons. - Cold ischaemia time of the donor kidney >30 hours. | |
| 9 | NCT01049334 | completed | 1 | phase 3 | ['pharyngitis'] | ["['A54.5', 'J02.0', 'J31.2', 'B08.5', 'J02.9', 'A50.03', 'J02.8']"] | ['placebo', 'flurbiprofen'] | ['CC(C1=CC(=C(C=C1)C2=CC=CC=C2)F)C(=O)O'] | Inclusion Criteria: 1. The patient has a complaint of sore throat. 2. If the patient is a female of childbearing potential, she has been using effective contraception since the last date of menses and is not breast-feeding or lactating. 3. If the patient is a female of childbearing potential, the patient must have a negative urine pregnancy. 4. The patient has provided written informed consent prior to any study-related procedures. Exclusion Criteria: 1. The patient has a history of an upper gastrointestinal ulcer within the past 60 days, is currently experiencing clinically significant upper gastrointestinal complaints, or is currently taking medication regularly (≥ three times in the previous week). 2. The patient has a history of any hepatic disease or renal dysfunction. 3. The patient has a history of chronic analgesic use (≥ three times per week over the prior four weeks). (Patients on low-dose aspirin therapy may be allowed in the study per investigator's clinical decision.) | |
| 10 | NCT00398983 | completed | 0 | phase 2/phase 3 | ['acute myelogenous leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['decitabine'] | ['C1C(C(OC1N2C=NC(=NC2=O)N)CO)O'] | Inclusion Criteria: - Adult patients (greater than 18 years) with acute myelogenous leukemia (AML) by World Health Organization (WHO) criteria (greater than 20% blasts) and unfavorable risk cytogenetics (including intermediate and poor risk categories) in first CR or complete remission without full platelet recovery (CRp) - Adult patients (greater than 18 years) in second or subsequent Complete Response (CR) (or CRp) - Patients in first CR (or CRp) may have received any induction chemotherapy regimen; they may have received post-remission consolidation therapy (except for transplant) prior to inclusion in this protocol - Patients in 2nd or subsequent CR (or CRp) may have received any appropriate salvage regimen before achieving CR and may have received further therapy before inclusion - Performance status of 0, 1, or 2 - Adequate organ function with creatinine less than or equal to 2.0 mg/dL, bilirubin less than or equal to 3.5 mg/dL and aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) less than or equal to 3 times institutional upper limit of normal Exclusion Criteria: - Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization - Known to be HIV+ - Active and uncontrolled disease/infection as judged by the treating physician - Unable or unwilling to sign the consent form - No other investigational therapy within the past 14 days | |
| 11 | NCT01185847 | completed | 0 | phase 2 | ['non-squamous non-small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['ro5083945', 'cisplatin', 'gemcitabine', 'pemetrexed'] | ['Status: 503', 'Status: 503', 'Status: 503', 'Status: 503'] | Inclusion Criteria: - Adult patients, >/=18 years of age - Advanced (IIIb), metastatic (IV) or recurrent non-small cell lung cancer - At least 1 measurable disease lesion as per RECIST criteria - Confirmed presence of EGFR in tumor tissue - ECOG performance status 0-1 - Adequate hematological, renal and liver function Exclusion Criteria: - Prior chemotherapy or treatment with another systemic anti-cancer agent - Radiotherapy within the last 4 weeks, except for limited field palliative radiotherapy for bone pain relief - Symptomatic or active CNS metastases - Recent history of poorly controlled hypertension (systolic >180mmHg or diastolic >100mmHg) - Requirement for steroids > 40 mg prednisolone | |
| 12 | NCT00288379 | completed | 1 | phase 3 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['formoterol', 'budesonide/formoterol'] | ['CC(CC1=CC=C(C=C1)OC)NCC(C2=CC(=C(C=C2)O)NC=O)O', 'Status: 400'] | Inclusion Criteria: - A diagnosed history of asthma for at least 6 months - Mild and stable asthma, only using β2-agonists as needed for the last 4 weeks. - FEV1 >70% of predicted normal value (post-bronchodilator value). - Skin prick test positive to pollen, animal dander or house dust mite. Exclusion Criteria: - Any significant respiratory disease, other than asthma. - Upper or lower respiratory tract infection within 4 weeks before inclusion. - Use of: 1. inhaled glucocorticosteroid treatment for the last 8 weeks prior to inclusion or ever used oral glucocorticoid treatment for asthma. 2. inhaled long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and anti-leukotrienes within 2 weeks of screening. 3. regular NSAIDs | |
| 13 | NCT00423917 | completed | 0 | phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['fulvestrant'] | ['CC12CCC3C(C1CCC2O)C(CC4=C3C=CC(=C4)O)CCCCCCCCCS(=O)CCCC(C(F)(F)F)(F)F'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed breast cancer - Metastatic disease - Must have received an aromatase inhibitor (e.g., letrozole, anastrozole, or exemestane) in an adjuvant or metastatic setting - If tumor is HER2 positive (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) the patient must have received ≥ 1 prior trastuzumab (Herceptin®)-containing regimen unless there is a contraindication to trastuzumab - Measurable or nonmeasurable disease, including any of the following : - Bone metastasis - Pleural/pericardial effusion - Ascites - Inflammatory skin changes - No microscopic residual disease only - Enrolled on or refused enrollment on clinical trial NCCTG-N0392 - No evidence of active brain metastasis including leptomeningeal involvement - CNS metastasis controlled (i.e., at least 2 months of no symptoms or evidence of progression) by prior surgery and/or raditherapy are allowed - Hormone receptor status: - Estrogen and/or progesterone receptor-positive tumor PATIENT CHARACTERISTICS: - Male or female - Female patients must be post-menopausal based on any 1 of the following criteria: - Age ≥ 60 years - Age ≥ 45 years with last menstrual period ≥ 12 months prior to study entry - Estradiol and follicle-stimulating hormone levels in postmenopausal range - History of bilateral oophorectomy - ECOG performance status 0-2 - Life expectancy > 3 months - Fertile patients must use effective contraception during and for 30 days after completion of study treatment - WBC ≥ 3,000 mg/dL - Hemoglobin > 8 g/dL - Absolute neutrophil count > 1,000/mm³ - Platelet count ≥ 100,000/mm³ - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - Alkaline phosphatase ≤ 2.5 times ULN - AST and ALT ≤ 2.5 times ULN - Creatinine ≤ 1.5 times ULN - Urine protein < 1+ OR < 1 g of protein by 24-hour urine collection - No nephrotic syndrome - No uncontrolled hypertension (i.e., blood pressure [BP] > 160/90 mm Hg on ≥ 2 occasions at least 5 minutes apart) - Patients who have recently started or adjusted antihypertensive medications are eligible provided BP is < 140/90 mm Hg on any new regimen for ≥ 3 different observations in ≥ 14 days - No clinically significant cardiac disease, including any of the following: - Congestive heart failure - Symptomatic coronary artery disease - Unstable angina - Cardiac arrhythmias not well controlled with medication - Myocardial infarction within the past 12 months - No arterial or venous thrombosis within the past 12 months - No hemoptysis or gastrointestinal hemorrhage within the past 6 months - No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 4 weeks - No significant traumatic injury within the past 4 weeks - No active, unresolved infection - No history of hypertensive crisis or hypertensive encephalopathy - No history of bleeding diathesis or uncontrolled coagulopathy - No history of cerebrovascular accident, hemorrhage, or stroke - No allergy or hypersensitivity to drug product excipients, murine antibodies, or agents chemically similar to study drugs - No other malignancy within the past 3 years except for basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No other serious medical condition that would preclude study therapy or compliance PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Prior radiotherapy to a target lesion allowed provided there has been clear progression since radiotherapy was completed - At least 4 weeks since prior radiotherapy - Single-dose radiation for palliation or to a nontarget lesion only allowed within the past 4 weeks - No more than 1 prior chemotherapy regimen for metastatic disease - No more than 2 prior endocrine (hormonal) therapy regimens in the neoadjuvant, adjuvant, or metastatic setting - At least 4 weeks since prior major surgery or open biopsy - At least 4 weeks since prior chemotherapy or immunologic therapy - At least 2 weeks since prior and no concurrent use of any of the following agents: - Aspirin (daily low-dose [81 mg] aspirin allowed]) - Thrombolytic agents - Anticoagulants (low-dose anticoagulation therapy to maintain patency of a vascular access device is allowed) - No concurrent treatment in another clinical study with investigational procedures or investigational therapies - No other concurrent anticancer therapy, including chemotherapy, biologic agents, or radiotherapy - No routine use of granulocyte colony-stimulating factors during course 1 - No concurrent oprelvekin | |
| 14 | NCT01326312 | terminated | fda clinical hold | 0 | phase 2 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['gtx-758 1000mg', 'lupron depot', 'gtx-758 2000mg'] | ['Status: 503', 'Status: 503', 'Status: 503'] | Inclusion Criteria: 1. be between age 45 and 80 years of age 2. be able to communicate effectively with study personnel 3. ECOG is < or = 2 4. screening serum total testosterone> or = 150ng/dL 5. have prostate cancer, confirmed by pathology report 6. have not been treated with androgen deprivation therapy(chemical or surgical 7. have a clinical indication for the initiation of androgen deprivation therapy 8. give written informed consent prior to any study specific procedures 9. subject must agree to use acceptable methods of contraception Exclusion Criteria: 1. known hypersensitivity or allergy to estrogen or estrogen like drugs 2. a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol 3. history of abnormal blood clotting,Factor V Leiden clotting disorder, thrombotic disease 4. have ALT or AST above 2 times the upper normal limit 5. have alkaline phosphatase greater than 3 times UNL and/or bilirubin levels above 2mg/dL at baseline 6. patients cannot have brain or spinal cord metastases 7. patients cannot have or be at risk for spinal cord compression from bone metastases 8. received an investigational drug within a period of 90 days prior to enrollment in the study 9. received the study medication previously 10. currently taking testosterone, testosterone-like agents, or antiandrogens including 5-alpha reductase inhibitors within 4 weeks of randomization 11. currently taking Saw Palmetto or PC-SPES (the subject may be considered for randomization after a 4 week washout period prior to randomization) 12. have taken diethylstilbestrol or other estrogen products within the previous 12 months prior to randomization 13. have taken body building or fertility supplements within 4 weeks of admission into the study (steroids and steroid like supplements) 14. have a history of cancer other than prostate cancer, superficial bladder cancer (with no recurrence in the last 5 years) and/or non-melanoma carcinoma of the skin 15. QTcB>480 msec, If the first QTcB reading exceeds 480msec two additional ECGs are to be performed separated at least 5 min apart, then take the average of the three QTcB or readings to determine if the subject satisfies the above criteria. If the average QYcB reading is >480 msec then the subject is excluded. |
| 15 | NCT00581607 | completed | 0 | phase 2/phase 3 | ['sarcoidosis', 'pulmonary arterial hypertension'] | ["['D86.9', 'D86.2', 'D86.0', 'D86.3', 'D86.1', 'D86.89', 'D86.82']", "['I27.21']"] | ['bosentan', 'placebo', 'bosentan', 'placebo'] | ['CC(C)(C)C1=CC=C(C=C1)S(=O)(=O)NC2=C(C(=NC(=N2)C3=NC=CC=N3)OCCO)OC4=CC=CC=C4OC', 'Status: 503', 'Status: 503'] | Inclusion Criteria: - Patients with known sarcoidosis 21. - Age 18 or greater - Patients with documented pulmonary hypertension with a PA mean > 25 mm Hg as measured by cardiac catheterization within six months of entry into the study. Pulmonary artery occluding pressure and or left ventricular end diastolic pressure must be less than 15 mm Hg. - Patients with WHO class II or III - Six minute walk distance of between 100 to 500 meters - Patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab - Patients able to provide written consent Exclusion Criteria: - Patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) n the prior 28 days. Patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker. - Patients with severe airway obstruction as defined by FEV1/FVC of less than 35% - Patients with World Health Organization (WHO) class IV status. - Patients who are pregnant or breast feeding - Patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35% - Cardiac index < 2.0 liters and/or right atrial pressure >15 mm Hg - Significant liver dysfunction not due to sarcoidosis. - Patients with severe other organ disease felt by investigators to impact on survival during the course of the study. - Patients unable to perform the 6 minute walk study | |
| 16 | NCT00220805 | completed | 0 | phase 2 | ['macular degeneration'] | ["['H35.30', 'H35.353', 'H35.351', 'H35.352', 'H35.359', 'H35.3130', 'H35.3230']"] | ['immune globulin intravenous [human], 10% caprylate/chromatography purified', 'albumin (human) 25%, united states pharmacopeia (usp)'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - The best corrected visual acuity must be in the range of 20/40 to 20/200 on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart (0.5 - 0.1). - Patient complaint of visual loss within the last three months prior to study entry. - Documented visual loss on a visual acuity chart in the 3-month period prior to the beginning of the run-in period. - Signed written informed consent prior to initiation of any study-related procedures. Exclusion Criteria: - Treatment with IGIV within the last 3 months prior to the run-in. - Previous photodynamic therapy (PDT) or vitrectomy or transpupillary thermotherapy (TTT) or any specific pre-treatment of CNV - Subfoveal blood in the study eye if ≥ 1/2 disc diameter as measured by slit lamp during run-in period. - History of anaphylaxis or severe systemic response to immunoglobulin or with a blood product. - Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease, or severe or uncontrolled hypertension (diastolic > 95 mmHg or systolic >170 mmHg) - Females, who are pregnant, breast feeding, or if of childbearing potential, unwilling to practice adequate contraception throughout the study. - History of renal insufficiency or serum creatinine levels > 221 µmol/L (2.5 mg/dL). - Known selective immunoglobulin A (IgA) deficiency - Other investigational drugs received within the past 3 months. - Conditions whose symptoms and effects could alter protein catabolism and/or immunoglobulin (IgG) utilization (e.g. protein-losing enteropathies, nephrotic syndrome). - Known hypercoagulable state. - Patients on continuous systemic steroid treatment - Mentally challenged adult subjects who cannot give independent informed consent. - History of thromboembolic events. - Diabetes mellitus requiring drug treatment. - Known severe hypersensitivity to sodium fluorescein. - Acute or known ocular diseases such as glaucoma, arterial or venous occlusions, acute ischemic optic-neuropathy, impairment of visual acuity due to opacities in the lens (LOCSIII: NO 5-6 or C: 4-5 or P 4-5) or vitreous which may influence the evaluation of the therapeutic effect. | |
| 17 | NCT00072267 | completed | 0 | phase 2 | ['fallopian tube cancer', 'ovarian cancer', 'primary peritoneal cavity cancer'] | ["['C57.00', 'C57.01', 'C57.02']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C30.0', 'Z12.81', 'D14.0', 'C14.8', 'D37.09', 'Z86.003', 'Z85.818']"] | ['7-hydroxystaurosporine', 'topotecan hydrochloride'] | ['CC12C(C(CC(O1)N3C4=CC=CC=C4C5=C6C(=C7C8=CC=CC=C8N2C7=C53)C(NC6=O)O)NC)OC', 'Status: 503'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer - Progressive, persistent, or recurrent disease - Measurable disease outside prior radiotherapy field unless disease progression occurred after radiotherapy - Tumor lesions accessible for biopsy - Patients with a medical contraindication to tumor biopsy may be allowed at the discretion of the principal investigator - No more than 2 prior chemotherapy regimens - At least 1 regimen must have contained a platinum agent (i.e., carboplatin or cisplatin) - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 12 weeks 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 Hepatic - Bilirubin no greater than upper limit of normal (ULN) - AST/ALT no greater than 2.5 times ULN Renal - Creatinine no greater than ULN OR - Creatinine clearance at least 50 mL/min Cardiovascular - No history of coronary artery disease - No symptomatic cardiac dysfunction - No cardiac pathology by electrocardiogram* NOTE: *Patients with symptomatic coronary artery disease must undergo an electrocardiogram Pulmonary - No symptomatic pulmonary dysfunction Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 8 weeks after study participation - No prior allergic reaction attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents - No insulin-dependent diabetes mellitus - Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion of the investigator - No other concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior biologic therapy and recovered Chemotherapy - See Disease Characterisitcs - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No prior topotecan - No other prior topoisomerase I inhibitors Endocrine therapy - More than 4 weeks since prior hormonal therapy and recovered Radiotherapy - See Disease Characteristics - More than 4 weeks since prior radiotherapy and recovered - No prior radiotherapy to more than 40% of bone marrow - No prior mediastinal irradiation Surgery - More than 4 weeks since prior surgery and recovered Other - No other concurrent anticancer therapy - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients | |
| 18 | NCT01121484 | 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', 'placebo'] | ['Status: 503'] | Inclusion Criteria: - Peri- and postmenopausal women aged 40 to 70 years who are fluent in both written and spoken English. - Postmenopausal status defined by 12 consecutive months of spontaneous amenorrhea; less than 12 consecutive months with at least 6 consecutive months of spontaneous amenorrhea and a pre-baseline follicle-stimulating hormone (FSH) level >40 mIU/mL; or 6 months postsurgical bilateral oophorectomy (with or without hysterectomy). Perimenopausal women defined by the presence of any of the following within 6 months before baseline: 1. an absolute change of 7 days or more in menstrual cycle length within 6 months before baseline; 2. a change in menstrual flow amount (2 or more flow categories, eg, from light or moderately light to moderately heavy or heavy); 3. a change in duration (absolute change of 2 or more days); or 4. periods of amenorrhea lasting at least 3 months. - A primary diagnosis of major depressive disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR), single or recurrent episode, without psychotic features using the modified Mini International Neuropsychiatric Interview (MINI). - A Montgomery and Asberg Depression Rating Scale (MADRS) total score >=25 at the screening and baseline (day -1) visits and no more than a 5-point improvement from screening to baseline. Exclusion Criteria: - Treatment with DVS SR (Pristiq®) at any time in the past and/or venlafaxine, ie, Effexor® or Effexor XR®, 1 year prior to baseline. - Treatment-resistant; eg, in the past 3 years if any of the following treatments have failed: (a) 3 or more previous adequate trials of >=2 classes of antidepressant medication, (b) electroconvulsive therapy, or (c) 2 adequate trials of psychotherapy (eg, behavior therapy, behavior-marital therapy). - 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. - Known presence of raised intraocular pressure or history of narrow-angle glaucoma. | |
| 19 | NCT01135433 | completed | 1 | phase 3 | ['type 2 diabetes mellitus'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['ipragliflozin', 'placebo', 'metformin'] | ['C1=CC=C2C(=C1)C=C(S2)CC3=C(C=CC(=C3)C4C(C(C(C(O4)CO)O)O)O)F', 'CN(C)C(=N)N=C(N)N'] | Inclusion Criteria: - Type 2 diabetic patients receiving with metformin mono-therapy for at least 6 weeks - HbA1c value between 7.0 and 9.5% - Body Mass Index (BMI) 20.0 - 45.0 kg/m2 Exclusion Criteria: - Type 1 diabetes mellitus patients - Serum creatinine > upper limit of normal - Estimated GFR < 60ml/min/1.73m2 - Proteinuria (albumin/creatinine ratio > 300mg/g) - Dysuria and/or urinary tract infection, genital infection - Significant renal, hepatic or cardiovascular diseases - Severe gastrointestinal diseases | |
| 20 | NCT01542788 | completed | 1 | phase 3 | ['chronic hepatitis c'] | ["['B18.2', 'B18.0', 'B18.1', 'B18.8', 'B18.9', 'K71.3', 'K71.4']"] | ['sof', 'rbv', 'placebo to match sof', 'placebo to match rbv'] | ['C1=NC(=NN1C2C(C(C(O2)CO)O)O)C(=O)N'] | Inclusion Criteria: - Infection with HCV genotype 2 or 3 - Cirrhosis determination - Subject meets one of the following classifications: 1. IFN unwilling 2. IFN ineligible 3. IFN intolerant - Screening laboratory values within defined thresholds - Subject has not been treated with any investigational drug or device within 30 days of the Screening visit - Use of highly effective contraception methods if female of childbearing potential or sexually active male Exclusion Criteria: - Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase - Pregnant or nursing female or male with pregnant female partner - Current or prior history of clinical hepatic decompensation - History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol - Excessive alcohol ingestion or significant drug abuse | |
| 21 | NCT00220740 | completed | 1 | phase 3 | ['polyradiculoneuropathy, chronic inflammatory demyelinating'] | ["['G61.81', 'G37.9', 'G37.8', 'G37.3']"] | ['immune globulin iv (human), 10% caprylate/chromatography purified', 'albumin (human) 25%, united states pharmacopeia (usp)'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - Documented diagnosis of CIDP must be made by a neurologist specializing/experienced in neuromuscular diseases based on: a) Progressive or relapsing motor and sensory dysfunction of more than one limb resulting from neuropathy over the 2 months prior to the date informed consent is obtained, and b) Cerebrospinal fluid (CSF) less than 50 white cells/µl since CIDP diagnosis (CSF testing studies are NOT mandatory) - Fulfillment of INCAT neurophysiological criteria for focal demyelinating polyradiculoneuropathy - Overall INCAT score between 2-9 and significant disability in upper or lower limb function in at least 2 limbs. (An INCAT score of 2 must be exclusively from leg disability to qualify.) Exclusion Criteria: - Treatment with IGIV or plasma within 3 months prior to entry - Steroids (Prednisolone or equivalent) > 10 mg/day or equivalent (i.e., > 20 mg every 2 days) during the last 3 months prior to entry - Treatment with immunomodulatory/immunosuppressive agents (azathioprin, tacrolimus,cyclosporin, Muromonab-CD3 (OKT3), any interferon), previous lymphoid irradiation or prior treatment with cyclophosphamide, methotrexate, mitoxantrone or any other immunosuppressant drug within the past 6 months prior to entry - Concomitant use of supplements containing any amount of fish oil within 30 days prior to entry - Respiratory impairment requiring mechanical ventilation - Myelopathy or evidence of central demyelination or persisting neurological deficits from stroke, central nervous system (CNS) trauma or peripheral neuropathies of other cause which include diabetes mellitus (defined as a history of type 1 or type 2 diabetes with fasting plasma glucose ≥ 7.0 mmol/L), uremic, toxic and familial neuropathies - Pure motor syndrome fulfilling criteria for multifocal motor neuropathy with conduction block. Lower motor neuron disorder with motor weakness in an upper limb, without sensory deficit and with proximal conduction block (50% decrease in amplitude/area with proximal distal stimulation ) in motor nerves and normal sensory nerve conduction studies. - Clinical or known evidence of associated systemic diseases that might cause neuropathy, including but not limited to connective tissue disease, HIV infection, hepatitis, Lyme disease, cancer (with the exception of benign skin cancer), Castleman's disease and systemic lupus erythematosus, diabetes mellitus (defined as a history of type 1 or type 2 diabetes with fasting plasma glucose ≥ 7.0 mmol/L), a malignant plasma cell dysplasia, immunoglobulin M (IgM) paraproteinemia, and amiodarone therapy. - History of anaphylaxis or severe systemic response to immunoglobulin or with a blood product. - Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease, or history of congestive heart failure, severe hypertension (diastolic pressure >120 mmHg or systolic >170 mmHg). - Females who are pregnant, breast feeding, or if of childbearing potential, unwilling to practice adequate contraception throughout the study. - Known hyperviscosity. - History of renal insufficiency or serum creatinine levels > 221 µmol/L (2.5 mg/dL). - Known selective immunoglobulin A (IgA) deficiency. - Other investigational drugs received within the 30 days prior to entry - Conditions whose symptoms and effects could alter protein catabolism and/or immunoglobulin G (IgG) utilization (e.g. protein-losing enteropathies, nephrotic syndrome). - Known hypercoagulable state. - Mentally challenged adult subjects who cannot give independent informed consent. - Subjects with uncompensated hypothyroidism (abnormally high thyroid-stimulating hormone (TSH) and abnormally low T4) or vitamin B12 deficiency (abnormally low) within the last 3 months prior to entry. | |
| 22 | NCT01320202 | completed | 1 | phase 3 | ['renal failure chronic requiring hemodialysis'] | ["['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']"] | ['soluble ferric pyrophosphate (sfp)'] | ['Status: 503'] | Stage 1: Main Inclusion Criteria: - Adult subject ≥ 18 years of age undergoing chronic hemodialysis three or four times per week for chronic kidney disease (CKD) for at least 4 months, and expected to remain on hemodialysis three to four times weekly and be able to complete the duration of the study. - Received IV iron therapy between 6 months and 2 weeks prior to enrollment in order to replace iron losses resulting from hemodialysis procedure. - Mean Screening Hgb ≥ 9.5 to ≤ 11.5 grams per deciliter (g/dL). - Mean Screening Transferrin Saturation (TSAT) ≥ 15% to ≤ 40%. - Mean Screening serum ferritin ≥ 200 to ≤ 800 micrograms per liter (µg/L). - If being administered epoetin, darbepoetin, or CERA, epoetin dose ≤ 45,000 Units (U)/week, darbepoetin dose ≤ 200 micrograms (µg)/week, or CERA dose ≤ 400 micrograms (µg)/month during the four weeks prior to enrollment. Main Exclusion Criteria: - Patient has living kidney donor identified or living-donor kidney transplant scheduled. (Note: Patients awaiting deceased-donor transplant need not be excluded.) - Vascular access for dialysis with femoral catheter or non-tunneled catheter. - Received a total of > 800 milligrams (mg) IV iron during the 8 weeks prior to enrollment - If being administered an ESA, route of administration change or ESA dose change > 35% (i.e., [max - min dose]/max dose > 0.35) over the 2 weeks prior to screening. - Serum albumin < 3.0 grams per deciliter (g/dL) any time over the 8 weeks prior to enrollment. - Red Blood Cell (RBC) or whole blood transfusion within 12 weeks prior to enrollment. Stage 2: Main Inclusion Criteria: - Patient currently enrolled in the Stage 1 run-in period of study. - Undergoing chronic hemodialysis three or four times per week for chronic kidney disease (CKD), and expected to remain on hemodialysis three to four times weekly and be able to complete duration of the study. - Mean Hgb ≥ 9.5 to ≤ 11.5 g/dL over the three most recent consecutive every-week measurements prior to randomization. - Stable Hgb defined as ≤ 1.0 g/dL difference between the maximum and minimum Hgb values over the 3 weeks immediately prior to randomization. - Mean TSAT ≥ 15% to ≤ 40% over the two most recent consecutive every-other-week measurements prior to randomization. - Mean serum ferritin ≥ 200 to ≤ 800 µg/L over the two most recent consecutive every-other-week measurements prior to randomization. - If being administered epoetin, darbepoetin, or CERA, epoetin dose ≤ 45,000 U/week, darbepoetin dose ≤ 200 µg/week, or CERA dose ≤ 400 µg/month during the four weeks prior to randomization. Main Exclusion Criteria: - Patient has living kidney donor identified or living-donor kidney transplant scheduled. (Note: Patients awaiting deceased-donor transplant need not be excluded.) - Vascular access for dialysis with femoral catheter or non-tunneled catheter. - Received any amount of IV iron during the 4 weeks prior to randomization. - If being administered an (Erythropoietin Stimulating Agent) ESA, change in dose over the 6 weeks immediately prior to randomization. - Serum albumin < 3.0 g/dL any time over the 8 weeks prior to randomization. - RBC or whole blood transfusion during Stage 1. Stage 3: Main Inclusion Criteria: - Patient randomized in Stage 2 who has completed the full duration of Stage 2 and less than 4 weeks have elapsed since completion of Stage 2, OR - Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for protocol-defined Protocol-Mandated Change in Anemia Management and less than 4 weeks have elapsed since withdrawal from Stage 2, OR - Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for Hgb >11.5 g/dL over ≥ 1 week confirmed by ≥ 2 consecutive measurements AND an associated increase in Hgb by ≥ 1 g/dL over 4 weeks. Main Exclusion Criteria: - Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for any reason other than as noted in inclusion criteria above. | |
| 23 | NCT00259779 | completed | 1 | phase 3 | ['chronic obstructive pulmonary disease'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['budesonide/formoterol', 'prednisolone'] | ['Status: 400', 'CC12CC(C3C(C1CCC2(C(=O)CO)O)CCC4=CC(=O)C=CC34C)O'] | Inclusion Criteria: - Patients with chronic obstructive pulmonary disease and an acute exacerbation - After the acute treatment a simple pulmonary function test shows a value of 30%-60% of the predicted normal value. - Patients, who, based on the clinical examination after the initial acute treatment, are candidates for a course of oral steroids for the treatment of acute symptoms due to chronic obstructive pulmonary disease Exclusion Criteria: - Diagnosis/history of asthma - Oxygen uptake (saturation) is <92% after the initial acute treatment - A requirement for regular use of oxygen therapy - Regular treatment with any inhaled steroid >1 000 µg/day at study entry Additional inclusion and exclusion criteria will be evaluated by the investigator | |
| 24 | NCT00049803 | completed | 1 | phase 3 | ['narcolepsy'] | ["['G47.411', 'G47.419', 'G47.421', 'G47.429']"] | ['sodium oxybate'] | ['C(CC(=O)[O-])CO.[Na+]'] | INCLUSION CRITERIA - Have signed & dated informed consent before beginning protocol procedures. - Willing & able to complete entire trial as described in protocol. - 16 years of age or older. - Have a history and presenting symptoms of excessive daytime sleepiness. - Have a history of cataplexy localizable to a specific muscle group(s) or part(s) of body during which the patient is lucid (not experiencing an inadvertent nap or micro sleep). - Have valid PSG & MSLT scores (collected during an overnight test) within last five years and a current diagnosis of narcolepsy according to the following criteria established by the American Sleep Disorders Association: (1) Recurrent daytime naps or lapses into sleep occur almost daily for at least 3 months; (2) Sudden bilateral loss of postural muscle tone occurs in association with intense emotion (cataplexy); (3) Polysomnography demonstrates one or more of the following: (a) Sleep latency less than 10 minutes; (b) REM sleep latency less than 20 minutes; (c) An MSLT that demonstrates a mean sleep latency of less than 5 minutes; (d) Two or more sleep-onset REM periods - Females who are surgically sterile, two years post-menopausal, or if of child-bearing potential, using a medically accepted method of birth control and agree to continue use of this method for the duration of the trial. - In the opinion of the investigator, have adequate support for the duration of trial to include transportation to and from trial site. In addition, if in the investigator's assessment it is clinically indicated, the patient is willing to not operate a car or heavy machinery for the duration of the trial or for as long as the investigator deems clinically indicated. EXCLUSION CRITERIA - Received gamma-hydroxybutyrate in the last 30 days. - Have taken any investigational therapy within 30-day period prior to initial screening visit for this trial. - Patients taking fluoxetine (Prozac). - Have been diagnosed with sleep apnea syndrome, defined as an Apnea Index > 10 per hour or an Apnea Hypopnea Index greater than 15 per hour, or have any other cause of daytime sleepiness, and have any other disorder(s) that can be considered a primary cause of excessive daytime sleepiness. - Taking hypnotics, tranquilizers, antihistamines (except for non-sedating antihistamines), benzodiazepines or clonidine at the start of the baseline period. Patients taking anticonvulsants are not eligible to participate even if willing to washout anticonvulsants for the trial. - Experiencing unstable cardiovascular, endocrine, neoplastic (excluding localized basal cell carcinoma), gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological (other than narcolepsy/cataplexy), pulmonary, and/or renal disease which would place the patient at risk during the trial or compromise objectives outlined in the protocol. - Have psychiatric disorders, major affective or psychotic disorders, or other problems that, in the investigator's opinion, would preclude the patient's participation and completion of this trial or compromise reliable representation of subjective symptoms. - Have current or recent (within one year) history of a substance use disorder including alcohol abuse as defined by DSM-IV. - Serum creatinine greater than 2.0 mg/dL, abnormal liver function tests (SGOT [AST] or SGPT [ALT] more than twice the upper limit of normal), or elevated serum bilirubin (more than 1.5 times upper limit of normal), or pre-trial ECG results demonstrating clinically significant arrhythmias, greater than a first degree AV block or a history of myocardial infarction within last six months. - Have an occupation that requires variable shift work or routine night shift. - Have a clinically significant history of seizure disorder, a history of clinically significant head trauma (i.e., concussion resulting in clinically significant loss of consciousness) or past invasive intracranial surgery, and are taking anticonvulsant medications. | |
| 25 | NCT00655551 | completed | 1 | phase 3 | ['partial epilepsies', 'partial onset seizures'] | ["['G40.011', 'G40.019', 'G40.001', 'G40.009']"] | ['lacosamide', 'lacosamide', 'lacosamide'] | ['Status: 503', 'Status: 503', 'Status: 503'] | Inclusion Criteria: - Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures - Stable dose regimen of 1 to 2 marketed antiepileptic drug(s) (AED(s)) for 28 days prior to screening and duration of trial - Acceptable candidate for venipuncture and intravenous (iv) infusion - At least 1 partial seizure with motor component per 90 days - Maximum allowed seizure frequency during 28 days prior to screening is 40 partial seizures of any type Exclusion Criteria: - Previous use of lacosamide - History of primary generalized seizures - History of status epilepticus within last 12 months - History of cluster seizures during 8 week period prior to screening - Non-epileptic events, including psychogenic seizures that could be confused with seizures - Use of neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening - Received any rescue benzodiazepines more than once during the 28 days prior to screening - Concomitant treatment of felbamate or previous felbamate therapy within last 6 months - Prior or concomitant vigabatrin use | |
| 26 | NCT00378183 | completed | 1 | phase 4 | ['schizoaffective disorder', 'schizophrenia'] | ["['F25.9', 'F25.0', 'F25.1', 'F25.8']", "['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['risperidone'] | ['CC1=C(C(=O)N2CCCCC2=N1)CCN3CCC(CC3)C4=NOC5=C4C=CC(=C5)F'] | Inclusion Criteria: - Patients who have a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) diagnosis of schizophrenia or schizoaffective disorder - Taking a stable dose of olanzapine for at least 30 days - Have not experienced an acute exacerbation of their psychotic symptoms in the preceding 3 months - Either had only a marginal clinical response to olanzapine, or had unacceptable side effects related to weight gain including obesity, diabetes or abnormal glucose metabolism Exclusion Criteria: - Patients with a history of treatment failure with, or significant adverse events attributable to, risperidone, or known sensitivity to risperidone - A history of antipsychotic therapy other than olanzapine in the 30 days preceding randomization - Presence of serious or unstable illnesses: liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances - Diagnosis of substance dependence - Pregnant or nursing female, or those lacking adequate contraception | |
| 27 | NCT00481845 | terminated | low accrual | 0 | phase 2 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['vandetanib', 'anastrozole'] | ['CN1CCC(CC1)COC2=C(C=C3C(=C2)N=CN=C3NC4=C(C=C(C=C4)Br)F)OC', 'CC(C)(C#N)C1=CC(=CC(=C1)CN2C=NC=N2)C(C)(C)C#N'] | Inclusion Criteria: Histologically confirmed invasive, hormone receptor-positive (ER and/or PR positive) breast cancer - Stage I-III breast cancer including any primary tumor ≥ 1 cm by ultrasound - Diagnosis by core needle biopsy with placement of metallic clip at tumor site - Sentinel lymph node biopsy (US-guided FNA may be substituted if palpable axillary lymphadenopathy) - Evaluation by a surgeon to determine eligibility for breast conservation - Postmenopausal status (age ≥ 60 yo; or < 60 yo and FSH and estradiol in the postmenopausal range, prior bilateral oophorectomy) - Serum creatinine < 1.5 x upper limit of normal (ULN) or creatinine clearance > 50 mL/minute (calculated by Cockcroft-Gault formula.) - Serum bilirubin < 1.5 x ULN - Serum potassium ≥ 4 mmol/L (supplementation allowed) - Serum calcium or magnesium within normal range (supplementation allowed) - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 x ULN or alkaline phosphatase (ALP) ≤ 2.5 x ULN - ECOG Performance Status 0,1,2 - ECG QTc < 480 msec - Measurable disease - Written, informed consent Exclusion Criteria:- Inflammatory breast cancer - Metastatic breast cancer excluding disease in regional lymph nodes - Inoperable disease considered irreversible with neoadjuvant endocrine therapy - HER2-overexpressed breast cancer - Prior chemotherapy or radiotherapy for the treatment of the current breast cancer - Prior hormonal therapy for the treatment of the current breast cancer - Prior surgical biopsy, lumpectomy, mastectomy for the current breast cancer - Any concurrent condition which in the Investigator's opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol - Currently active diarrhea that may affect the ability of the patient to absorb ZD6474 or tolerate diarrhea - Clinically significant cardiac event such as myocardial infarction; New York Heart Association (NYHA) classification of heart disease >2 within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia. - History of arrhythmia (multifocal premature ventricular contractions (PVCs), bigeminy, trigeminy, ventricular tachycardia (VT) or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained VT. Atrial fibrillation controlled on medication is not excluded. - Previous history of QTc prolongation as a result of another medication that required discontinuation of that medication. - Congenital long QT syndrome or 1st degree relative with unexplained sudden death < 40 years of age. - Presence of left bundle branch block (LBBB). - QTc with Bazett's correction that is unmeasurable, or ≥ 480 msec on screening ECG. If a patient has QTc ≥ 480 msec on screening ECG, the screen ECG may be repeated twice (at least 24 hours apart). The average QTc from the three screening ECGs must be < 480 msec in order for the patient to be eligible for the study. - Use of any concomitant medication that may cause QTc prolongation, induce Torsades de Pointes or induce CYP3A4 function. - Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm hg). - Previous or current malignancies of other histologies within the last 5 years, with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin. - Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy. - Receipt of any investigational agents within 30 days prior to commencing study treatment - Previous enrollment or randomization of treatment in the present study |
| 28 | NCT00755261 | terminated | the study has been terminated due to low accrual. | 0 | phase 2 | ['sarcoma', 'soft tissue sarcoma'] | ["['C96.A', 'C46.9', 'C96.22', 'C46.0', 'C46.2', 'C92.31', 'C92.32']", "['C46.1']"] | ['avastin', 'doxorubicin'] | ['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'] | Inclusion Criteria: 1. Pathologically confirmed intermediate or high grade locally advanced or metastatic soft tissue sarcoma. 2. The presence of measurable disease 3. Normal renal function (spot dipstick <2** or urine protein: creatinine ratio >1.0 4. Normal Hepatic function (total bilirubin within JOHC normal limits, transaminases (AST and ALT <3 times upper limit of normal 5. Hematologic parameters as defined as ANC >1500/mm³ and Platelets > 100,000/mm³. 6. Performance status 0-1 on ECOG scale 7. Use of effective means of contraception (men and women) in subjects of child-bearing age 8. No prior use of mesna, adriamycin, ifosfamide or Avastin®. 9. Baseline ECHO or MUGA with LVEF > or = 50-60%. 10. Age ≥ 18 Exclusion Criteria: 1. Major surgery within 28 days 2. History of proteinuria > 1+ 3. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin® cancer study 4. Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications) 5. Any prior history of hypertensive crisis or hypertensive encephalopathy 6. New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E) 7. History of myocardial infarction or unstable angina within 6 months prior to study enrollment 8. History of stroke or transient ischemic attack within 6 months prior to study enrollment 9. Symptomatic peripheral vascular disease 10. Significant vascular disease (e.g., aortic aneurysm, aortic dissection) 11. Evidence of bleeding diathesis or coagulopathy 12. Current or recent (within 10 days of enrollment) use of aspirin (>325 mg/day) or chronic use of other NSAIDs 13. Current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin). 14. Known central nervous system or brain metastases 15. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study 16. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment 17. Pregnant (positive pregnancy test) or lactating 18. Proteinuria :creatinine (UPC) ratio ≥ 1.0 at screening or Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible). 19. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0 20. Serious, non-healing wound, ulcer, or bone fracture 21. Known hypersensitivity to any component of Avastin® 22. Inability to comply with study and/or follow-up procedures |
| 29 | NCT00216528 | completed | 1 | phase 4 | ['schizophrenia'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['risperidone'] | ['CC1=C(C(=O)N2CCCCC2=N1)CCN3CCC(CC3)C4=NOC5=C4C=CC(=C5)F'] | Inclusion Criteria: - Subjects with schizophrenia or schizoaffective disorder - Subjects who have experienced relapse or re-admission previously - Subject and/or his/her relative, guardian or legal representative who has signed the informed consent form Exclusion Criteria: - First antipsychotic treatment ever - On clozapine during the last 3 months - Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities - Subjects that are previously on concomitant use of Risperdal Consta within 60 days prior to entry - Previous sensitivity history to risperidone - History or current symptoms of tardive dyskinesia - History of neuroleptic malignant syndrome - Pregnant or breast-feeding female - Female patient of childbearing age without adequate contraception (adequate contraception includes: abstinence, oral contraceptive, intrauterine devices, barrier method (diaphragm or condom) plus spermicide - Norplant TM or Depo-Provera TM. A female patient of childbearing potential must have an adequate contraception and a negative urine pregnancy test at every visit) | |
| 30 | NCT02232555 | completed | 1 | phase 3 | ['depressive disorder, major'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['duloxetine', 'placebo'] | ['CNCCC(C1=CC=CS1)OC2=CC=CC3=CC=CC=C32'] | Inclusion Criteria: - Male or female outpatients who meet the criteria for MDD according to the Diagnostic and Statistic Manual of mental disorders, 4th edition (DSM-IV) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI) - Montgomery-Asberg Depression Rating Scale (MADRS) score ≥20 at screening and baseline (Visits 1 and 2) - Patients must have had at least one previous episode of depression in their medical history - Painful physical symptoms (PPS) with a score ≥ 3 on the BPI-SF scale for average pain at screening and baseline - Patient aged 18 years or older at the screening visit - CGI-Severity score ≥ 4 at Visits 1 and 2 - Patients willing and able to comply with the scheduled visits, tests and procedures required by the protocol - Written informed consent obtained at the screening visit, in accordance with Good clinical practice (GCP) and local regulatory requirements, prior to any study procedure Exclusion Criteria: Neuro-psychiatric exclusions - Lack of response of the current episode to 2 or more adequate courses of antidepressant therapy given at a clinically appropriate dose and for a sufficient length of time in the judgement of the investigator - Any anxiety disorder as a primary diagnosis within the past 6 months (including panic disorder, obsessive-compulsive disorder, posttraumatic stress disorder, generalized anxiety disorder, and social phobia). Note: Specific phobias (i.e. agoraphobia, arachnophobia, etc.) will be allowed - Any diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders - Presence of an Axis II disorder which, in the judgement of the investigator, would interfere with compliance with the study protocol - History of serious suicide attempt or patient judged to be at serious suicidal risk in the opinion of the investigator and / or score > 2 for question 10 (suicide) of the MADRS - History of drug dependence, including alcohol or benzodiazepines, according to DSM-IV, in the previous year - Positive urine screen for drug abuse (cannabis, benzodiazepines, barbiturates, opiates, cocaine, amphetamines) Other medical exclusions - Patients requiring continuous treatment with analgesics (> step 2 WHO definition) because of chronic pain (> 6 months) - Patients with organic pain syndromes - Epilepsy or history of seizure disorder or of a treatment with anticonvulsant medication for epilepsy or seizures - Patients with a known diagnosis of raised intraocular pressure or at risk of acute narrow-angle glaucoma - Known diagnosis of congenital galactosaemia, glucose or galactose malabsorption syndrome, or lactose deficiency - Patients with severely impaired renal function, defined by a creatinine clearance < 30 mL/min (creatinine clearance was calculated by the central laboratory from the screening safety laboratory test - Acute liver injury (such as hepatitis) or severe (Child-Pugh Class C) cirrhosis - Abnormal initial ECG findings according to investigator's judgement - Serious medical illness or clinically significant laboratory abnormalities which, in the judgement of the investigator, are likely to require medication/ intervention or hospitalization during the course of the study - Women of childbearing potential not using a medically accepted means of contraception when engaging in sexual intercourse (e.g. intrauterine device, oral contraceptive, contraceptive patch, implant, or barrier devices) - Women who are pregnant or breast-feeding Pharmacological and other exclusions - Participation in another clinical trial within 30 days prior to screening (Visit 1) - Patients who have previously completed or withdrawn from this or any other study investigating duloxetine or have previously been treated with duloxetine - Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 2 or potential need to use a MAOI within 5 days after discontinuation of study drug - Treatment with fluoxetine within 28 days prior to Visit 2 - Treatment with any of excluded medications (listed in Protocol) within 7 days prior to Visit 2 - (excepted MAOI within 14 days and fluoxetine within 28 days) - Frequent and/or severe allergic reactions with multiple medications. Known hypersensitivity to duloxetine or any of the inactive ingredients - Electro-convulsive Therapy (ECT) or Transcranial Magnetic Stimulation (TMS) within one year prior to screening - Initiation or discontinuation of depression-oriented psychotherapeutic treatment (e.g. behavioural therapy, psychoanalytic therapy, cognitive therapy etc.) within 6 weeks prior to screening visit or planned use of such treatment at any time during the study | |
| 31 | NCT00963872 | terminated | lack of efficacy after interim analysis | 0 | phase 1/phase 2 | ['leukemia', 'lymphoma', 'multiple myeloma', 'myelodysplastic syndromes'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['C90.01', 'C90.02', 'C90.00']", "['D46.9', 'D46.C', 'D46.Z']"] | ['cyclophosphamide', 'fludarabine phosphate'] | ['C1CNP(=O)(OC1)N(CCCl)CCCl', 'C1=NC2=C(N=C(N=C2N1C3C(C(C(O3)COP(=O)(O)O)O)O)F)N'] | Inclusion Criteria: - Disease Criteria - Acute Leukemias: Must be in remission by morphology (<5% blasts). Note cytogenetic relapse or persistent disease without morphologic relapse is acceptable. Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse. (See exclusion criteria for more detailed definition) - Acute myeloid leukemia: high risk CR1 (as evidenced by preceding myelodysplastic syndrome (MDS), high risk cytogenetics such as those associated with MDS or complex karyotype, > 2 cycles to obtain complete remission (CR) or erythroblastic and megakaryocytic); second or greater CR. - Acute lymphoblastic leukemia/lymphoma: high risk CR1 as evidenced by high risk cytogenetics (e.g. t(9;22, t(1;19), t(4;11), other MLL rearrangements) or > 1 cycle to obtain CR; second or greater CR. - Burkitt's lymphoma in CR2 or subsequent CR - Natural Killer cell malignancies - Myeloproliferative syndromes/diseases: Chronic myelogenous leukemia (CML) in chronic or accelerated phase but patients must have failed or been intolerant to Imatinib mesylate. EXCLUDED: CML in refractory blast crisis, myelofibrosis, polycythemia vera, and essential thrombocytosis. - Myelodysplastic Syndrome: any subtype including refractory anemia (RA) if severe pancytopenia, high risk complex cytogenetics or International Prognostic Scoring System (IPSS) ≥ intermediate-2 (Int-2). Blasts must be less than 5%. If 5% or more requires therapy pre-transplant to reduce blast count to ≤5%. Patients who receive single agent 5-azacytidine, decitabine or immunomodulating drugs are eligible. - Large-cell lymphoma, Hodgkin's lymphoma and multiple myeloma: patients with chemotherapy sensitive disease that has failed or who are ineligible for an autologous transplant. Patients are eligible for umbilical cord blood (UCB) transplantation if there is no evidence of progressive disease by imaging modalities and/or biopsy. Persistent PET activity, though possibly related to lymphoma, IS NOT an exclusion criterion in the absence of computated tomography (CT) changes in size indicating progression. Large-cell and Hodgkin's lymphoma that is progressive on salvage therapy is NOT eligible. Patients with stable disease are eligible for transplantation if the largest residual nodal mass is < 5 cm (approximately). For patients who have responded to preceding therapy, the largest residual mass must represent a 50% reduction and be < 7.5 cm (approximately). - Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma which have progressed after at least two prior therapies. Patients with bulky disease should be considered for debulking chemotherapy before transplant. Patients with refractory disease are eligible, unless has bulky disease and an estimated tumor doubling time of less than one month. Patients with stable disease are eligible for transplantation if the largest residual nodal mass is < 5 cm (approximately). For patients who have responded to preceding therapy, the largest residual mass must represent a 50% reduction and be < 7.5 cm (approximately). - Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are eligible after initial therapy if chemotherapy sensitive. Mantle-cell lymphoma that is progressive on salvage therapy is NOT eligible. Patients with stable disease are eligible for transplantation if the largest residual nodal mass is < 5 cm (approximately). For patients who have responded to preceding therapy, the largest residual mass must represent a 50% reduction and be < 7.5 cm (approximately). - Umbilical Cord Blood Graft Selection - Two UCB units will be compose the graft, and each unit must be a 4-6 HLA-A, B, DRB1 antigen match to each other, as well as a 4-6 antigen match to the recipient. The combined cryopreserved nucleated cell dose of the 2 units must be ≥ 3 X 10^7/kg with each unit having a minimum cell dose of 1.5 X 10^7/kg. UCB units will be selected according to a common umbilical cord blood graft selection algorithm - Performance Status - adequate performance status defined as Karnofsky score ≥ 60 - Age 18 to 70 years of age; patients ≥ 70 but ≤ 75 years are eligible if the co-morbidity score is ≤ 2 - Organ Function - Cardiac: Left ventricular ejection fraction > 35%; absence of decompensated congestive heart failure; absence of uncontrolled arrhythmia - Pulmonary: DLCO > 30% of predicted; absence of O2 requirements - Hepatic: ALT, AST, alkaline phosphatase and bilirubin < 5 x upper limit of normal - Renal: Creatinine ≤ 2 mg/dl (patients with a creatinine > 1.2 or history of renal dysfunction must have calculated glomerular filtration rate (GFR) > 40 mL/min/1.73m2) - If recent mold infection e.g. Aspergillus - must have minimum of 30 days of appropriate treatment before transplant and infection controlled and be cleared by Infectious Disease. - The following conditions must be met: - If prior myeloablative autologous transplant, must be > 3 months but ≤ 12 months from transplant OR have received at least 2 cycles of multi-agent or highly immunosuppressive chemotherapy (i.e. induction for acute leukemia) within the 3 months preceding this study. OR - If neither prior myeloablative autologous transplant ≤ 12 months from transplant nor have received at least 2 cycles of multi-agent or highly immunosuppressive chemotherapy (i.e. induction for acute leukemia) within the 3 months preceding this study, patients are eligible as long as they receive equine anti-thymocyte globulin as part of the conditioning regimen. Exclusion Criteria: - Patients who have an available, medically suitable, 5-6/6 HLA-A, B, DRB1 matched sibling donor - Patients who are eligible for autologous transplantation - Prior allogeneic transplant - Acquired or inherited bone marrow failure syndromes such as aplastic anemia and Fanconi anemia - Pregnant or breast feeding - Evidence of HIV infection or known HIV positive serology - Current uncontrolled serious infection - Active central nervous system malignancy |
| 32 | NCT01010633 | completed | 1 | phase 3 | ['inflammation', 'pain'] | ["['H01.9', 'H30.93', 'H05.00', 'H30.003', 'H30.013', 'H30.033', 'H30.103']", "['N50.82', 'R07.2', 'R07.82', 'R10.13', 'R10.33', 'R14.1', 'R52']"] | ['vehicle of loteprednol etabonate', 'loteprednol etabonate'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - Subjects who are at least 18 years of age. - Subjects who are candidates for routine, uncomplicated cataract surgery. - Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye. Exclusion Criteria: - Subjects who have known hypersensitivity or contraindication to the study drug or components. - Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up. - Subjects with elevated intraocular pressure (>/= 21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye. - Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye. | |
| 33 | NCT00190723 | completed | 0 | phase 2 | ['malignant glioma'] | ["['R18.0', 'C17.3', 'G21.0', 'J91.0', 'C05.2', 'C10.0', 'C16.0']"] | ['enzastaurin'] | ['CN1C=C(C2=CC=CC=C21)C3=C(C(=O)NC3=O)C4=CN(C5=CC=CC=C54)C6CCN(CC6)CC7=CC=CC=N7'] | Inclusion Criteria: - You must be at least 18 years old - You must have been diagnosed with a recurrent brain tumor by MRI or CT scan - You must be able to swallow the LY317615 tablets Exclusion Criteria: - You are a woman who is pregnant or breastfeeding - In view of your doctor, you have significant heart, liver, kidney, or psychiatric disease | |
| 34 | NCT01442376 | completed | 1 | phase 3 | ['chemotherapy-induced nausea and vomiting'] | ["['D61.810']"] | ['palonosetron', 'palonosetron', 'ondansetron', 'placebo to ondansetron', 'placebo to ondansetron', 'placebo to palonosetron'] | ['C1CC2CN(C(=O)C3=CC=CC(=C23)C1)C4CN5CCC4CC5', 'Status: 503', 'Status: 503', 'Status: 503'] | Inclusion Criteria: - Written informed consent signed by parent(s)/legal guardians of the pediatric patient in compliance with the local laws and regulations. In addition signed children's assent form according to local requirements - Male or female in- or out-patients from neonates (full term) to <17 years at the time of randomization - Patient weight at least 3.2 kg - Histologically, and/or cytologically (or imaging in the case of brain tumors) confirmed malignant disease - Naïve or non-naïve to chemotherapy - Scheduled and eligible to receive at least one of the moderately or highly emetogenic chemotherapeutic agents on Study Day 1 - For patients aged ≥ 10 years to <17 years: ECOG PS ≤ 2 - For patients with known hepatic impairment: in the Investigator's opinion the impairment should not jeopardize patient's safety during the study - For patients with known renal impairment: in the Investigator's opinion the impairment should not jeopardize patient's safety during the study - For patients with known history or predisposition to cardiac abnormalities: in the Investigator's opinion the history/predisposition should not jeopardize patient's safety during the study - For patients with known clinically relevant abnormal laboratory values: in the Investigator's opinion the abnormality should not jeopardize the patient's safety during the study - Fertile patients (male or female) must use reliable contraceptive measures - Female patients who have attained menarche must have a negative pregnancy test at the screening visit (Visit 1) and at study treatment visit (Visit 2) Exclusion Criteria: - Lactating or pregnant female patient - Patient has received total body irradiation, upper abdomen radiotherapy, radiotherapy of the cranium, craniospinal regions or the pelvis within 1 week prior to study entry (screening) - Scheduled to receive concomitant total body irradiation, radiotherapy of the upper abdomen, lower thorax region, or cranium/craniospinal regions up to 24 hours after study drug administration - Known history of allergy to any component or other contraindications to any 5-HT3 receptor antagonists - Active infection - Uncontrolled medical condition - Marked baseline prolongation of QTc interval [QTcB or QTcF > 460 msec] in any of the ECG assessments at screening. For this purpose, assessment will rely on the automatic interpretation by the ECG machine - Patient suffering from ongoing vomiting from any organic etiology (including patients with history of gastric outlet obstruction or intestinal obstruction due to adhesions or volvulus) or patients with hydrocephalus - Patient who experienced any vomiting, retching, or nausea within 24 hours prior to the administration of the study drug - Patient who received any drug with potential anti-emetic effect within 24 hours prior to administration of study treatment, including but not limited to: - NK1- receptor antagonists (e.g. aprepitant) - 5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron); - Phenothiazines (e.g., perphenazine, prochlorperazine, promethazine, fluphenazine, chlorpromazine, thiethylperazine); - Butyrophenones (e.g., droperidol, haloperidol); - Benzamides (e.g., metoclopramide, alizapride); - Corticosteroids (e.g., prednisone, methylprednisolone; except inhaled steroids for respiratory disorders and topical steroids for skin disease with doses of ≤ 10 mg of prednisone daily or its equivalent); Corticosteroids foreseen in the chemotherapy regimen or to reduce intracranial pressure are allowed. According to the guidelines1,2, patients will receive also dexamethasone as a co-medication in accordance with standard clinical practice and if deemed appropriate by the Investigator. - Dimenhydrinate; Hydroxyzine; Domperidone; Lorazepam; Cyclizine; Cannabinoids; Scopolamine; Trimethobenzamide HCl; Meclizine hydrochloride; Pseudoephedrine HCl; - Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications; - Herbal preparations containing ephedra or ginger. - Patient aged ≤ 6 years who received any investigational drug (defined as a medication with no marketing authorization granted for any age group and any indication) within 90 days prior to Day 1, or patient aged > 6 years who received any investigational drug within 30 days prior to Day 1 or is expected to receive investigational drugs prior to study completion - Patient who participated in any previous trial with palonosetron | |
| 35 | NCT00698646 | completed | 1 | phase 4 | ['hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['valsartan + hctz', 'valsartan', 'hctz'] | ['CCCCC(=O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NNN=N3)C(C(C)C)C(=O)O', 'C1NC2=CC(=C(C=C2S(=O)(=O)N1)S(=O)(=O)N)Cl'] | Inclusion Criteria: - Age 70 years or older. - Patients with hypertension prior to being randomized into study. - Patients must have an office cuff MSSBP ≥ 140 and ≤ 200 mmHg systolic. - Have the ability to communicate and comply with all study requirements. - Provide written informed consent to participate in the study prior to any screening or study procedures. Exclusion Criteria: - Use of other investigational drugs within 30 days of enrollment. - History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. - Office blood pressure measured by office machine cuff with a mean of (3) MSDBP ≥ 120 mmHg at anytime during the screening / washout period. - Patients taking 3 or more antihypertensive drugs and MSSBP ≥ 160 mmHg at the time of Visit 1. - Other protocol-defined exclusion criteria may apply | |
| 36 | NCT00407550 | completed | 0 | phase 2 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['gemcitabine hcl', 'pemetrexed disodium', 'gemcitabine hcl'] | ['C1=CN(C(=O)N=C1N)C2C(C(C(O2)CO)O)(F)F.Cl', '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'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) - Stage IIIB (with controlled pleural effusion) OR stage IV disease - At least 1 measurable lesion whose longest diameter is ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan - No medically significant third-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures - No documented brain metastases unless all of the following criteria are met: - Successful local therapy has been completed - At least 2 weeks since prior corticosteroids - Brain imaging required for symptomatic patients only (to rule out brain metastases) - Concurrent enrollment in clinical trial MCCRC-RC0527 required PATIENT CHARACTERISTICS: - Life expectancy ≥ 12 weeks - ECOG performance status 0-1 - Absolute neutrophil count ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Hemoglobin ≥ 9.0 g/dL - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - Alkaline phosphatase ≤ 3 times ULN - AST and ALT ≤ 3 times ULN (5 times ULN for liver involvement) - Creatinine clearance ≥ 45 mL/min - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to take folic acid, cyanocobalamin (vitamin B12) supplementation, or dexamethasone and corticosteroids - Able to interrupt intake of aspirin and nonsteroidal anti-inflammatory agents for a total of 5 days - No severe and/or uncontrolled medical conditions, including any of the following: - Hypertension, labile hypertension, or history of poor compliance with antihypertensive medication - Angina pectoris - Congestive heart failure within the past 3 months, unless ejection fraction > 40% - Myocardial infarction within the past 6 months - Cardiac arrhythmia - Diabetes - Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung - New York Heart Association class III or IV heart disease - Clinically significant infection - No other serious medical condition or illness that would preclude study participation - No peripheral neuropathy ≥ grade 2 - No other malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or low-grade (Gleason score ≤ 6) localized prostate cancer - No significant weight loss (≥ 10%) within the past 6 weeks - No investigator site personnel directly affiliated with the study, or immediate family (i.e., spouse, parent, child, or sibling, whether biological or legally adopted) - No employees of Eli Lilly (i.e., employees, temporary contract workers, or designees responsible for conducting the study) - Immediate family of Eli Lilly employees may participate in Eli Lilly-sponsored clinical trials, but are not permitted to participate at an Eli Lilly facility PRIOR CONCURRENT THERAPY: - See Disease Characteristics - At least 2 weeks since prior corticosteroids - At least 4 weeks since prior radiation therapy involving > 25% of the bone marrow and recovered - At least 30 days since prior investigational therapy - No prior radiation therapy to the whole pelvis - No prior systemic chemotherapy for advanced non-small cell lung cancer - No prior pemetrexed disodium and/or gemcitabine hydrochloride - No prior or concurrent sorafenib tosylate and/or temsirolimus - No concurrent Hypericum perforatum (St. John's wort) - No other concurrent antitumor therapy - No concurrent agents that stimulate thrombopoiesis - Concurrent palliative radiation therapy allowed - Concurrent corticosteroids allowed for adrenal insufficiency or severe nausea and vomiting | |
| 37 | NCT01617434 | 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']"] | ['liraglutide', 'placebo'] | ['CCCCCCCCCCCCCCCC(=O)NC(CCC(=O)NCCCCC(C(=O)NC(CCC(=O)O)C(=O)NC(CC1=CC=CC=C1)C(=O)NC(C(C)CC)C(=O)NC(C)C(=O)NC(CC2=CNC3=CC=CC=C32)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(=O)N)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CC4=CC=C(C=C4)O)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(C(C)C)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CC5=CC=CC=C5)NC(=O)C(C(C)O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(CC6=CN=CN6)N)C(=O)O'] | Inclusion Criteria: - Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 U/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator) - HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive) - Body mass index (BMI) 20-45 kg/m^2 (both inclusive) Exclusion Criteria: - Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant - Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness - Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening - Impaired liver or renal function - Uncontrolled treated or untreated hypertension (systolic blood pressure (SBP) equal to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg) - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial - Known or suspected abuse of alcohol or narcotics | |
| 38 | NCT01014351 | completed | 0 | phase 2 | ['metastatic melanoma'] | ["['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']"] | ['paclitaxel', 'carboplatin', 'everolimus'] | ['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', 'C1CC(C1)(C(=O)O)C(=O)O.[NH2-].[NH2-].[Pt+2]', 'Status: 503'] | Inclusion Criteria: 1. Histologically confirmed metastatic melanoma. 2. Stage III or IV disease that is not amenable to resection. 3. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation. 4. ECOG Performance Status of 0 or 1. 5. Life expectancy ≥12 weeks. 6. No prior cytotoxic chemotherapy or targeted therapy. Immunotherapy is allowed (i.e., interleukin-2 or interferon). 7. Adequate hematological function: - absolute neutrophil count (ANC) ≥1500/µL and - platelets ≥100,000/µL and - hemoglobin >9 g/dL 8. Adequate renal function: serum creatinine ≤2.0 mg/dL or calculated (measured) GFR ≥50 mL/min. 9. Adequate hepatic function: - serum bilirubin ≤1.5 x institutional upper limit of normal (ULN); - aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, or ≤5 × ULN in patients with documented liver metastases. 10. Normal PT, INR. Patients on coumadin anticoagulation are eligible if they are on a stable dose, with an INR in the therapeutic range. 11. Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can be included after initiation of appropriate lipid lowering medication. 12. Age ≥18 years. 13. Ability to swallow whole pills. 14. Patient must be accessible for treatment and follow-up. 15. Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry. Exclusion Criteria: 1. Previous treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus), paclitaxel, or carboplatin. 2. Treatment with any investigational agent ≤4 weeks of protocol treatment. 3. Patients currently receiving anticancer therapies or who have received anticancer therapies ≤3 weeks of the start of the study drug (including radiation therapy, immunotherapy). 4. Patients, who have had a major surgery or significant traumatic injury ≤4 weeks of start of study drug or patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia). 5. Patients receiving chronic, systemic treatment with corticosteroids (dose >10 mg daily of methylprednisolone or equivalent) or other immunosuppressive agents. Topical or inhaled steroids are allowed. 6. Immunization with attenuated live vaccine ≤1 week of study or anytime during study treatment period. 7. Patients with active brain metastases are ineligible. Patients with treated brain metastases are eligible if (1) radiation therapy was completed ≥4 weeks prior to study entry; (2) surgery was completed ≥4 weeks prior to study entry; (3) follow-up scan shows no disease progression; and (4) patient does not require steroids. 8. Any severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study such as: - severely impaired lung function defined as a DLCO ≤50% of the normal predicted value and/or O2 saturation ≤88% at rest on room air. - symptomatic congestive heart failure of New York Heart Association Class III or IV. - unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant disease. - uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN. - active (acute or chronic) uncontrolled severe infections. - liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis. 9. Active, bleeding diathesis. 10. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). 11. A known history of human immunodeficiency virus (HIV) seropositivity. 12. Known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients. 13. Use of St. John's Wort is prohibited. Drugs or substances (e.g., grapefruits, star fruits, seville oranges, and their juices and products), known to be inhibitors or inducers of the isoenzyme CYP3A4 should be avoided. Co-administration with substrates, inducers, or inhibitors of P glycoprotein should also be avoided. 14. Female patients who are pregnant or breastfeeding or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are not acceptable as a sole method of contraception. (Women of childbearing potential [WOCBP] must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus.) WOCBP should continue to use effective contraception for 8 weeks after ending everolimus treatment. 15. Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin. 16. History of noncompliance to medical regimens. Patients unwilling to, or unable to, comply with the protocol. 17. History of any other disease, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or a condition that may render the patient at high risk for treatment complications using these agents. | |
| 39 | NCT00439192 | terminated | side effect profile did not match expectations | 0 | phase 2 | ['overactive bladder', 'urinary incontinence'] | ["['N32.81']", "['N39.492', 'R32', 'R39.81', 'N39.498', 'L24.A2']"] | ['elb245', 'tolterodine'] | ['CC1=CC(=C(C=C1)O)C(CCN(C(C)C)C(C)C)C2=CC=CC=C2'] | Inclusion Criteria: - Male or female outpatients at least 18 years of age - Symptoms of OAB for a minimum of 3 consecutive months prior to study entry; severity of OAB (as defined by patient reported symptoms) for a minimum of one month prior to study entry - Ability to use a toilet independently and without difficulty - No treatment with any medication against OAB during the 4 weeks prior to study entry - Written informed consent Exclusion Criteria: - Breastfeeding women, pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and not practicing a highly reliable method of birth control - Any local pathology, that might cause the bladder symptoms - Significant stress urinary incontinence or mixed stress/urgency incontinence - Any neurological disease affecting bladder function or muscle strength - Patient history of any lower urinary tract surgery or previous pelvic irradiation - Local administration of botulinum toxin within the last 9 months in the lower urinary tract - Start or change of a behavioral bladder training program - Post voiding residual volumes larger than 250ml or symptoms of clinically relevant bladder outlet obstruction - Nocturial polyuria - History of liver disease and/or impaired liver function - Cholestasis - Chronic alcohol or drug abuse - Evidence of significantly impaired renal function ( - Diabetes mellitus (type I or II) with significant peripheral neuropathy and/or polyuria - Inflammatory bowel disease such as Crohn's disease, or ulcerative colitis - Uncontrolled narrow angle glaucoma - Chronic use of carbamazepine or paracetamol - Participation in any drug study in the preceding 3 months - Concomitant treatment with strong CYP3A4 inhibitors - History or evidence of relevant cardiovascular or cerebrovascular disorders |
| 40 | NCT00156065 | completed | 1 | phase 3 | ['schizophrenia'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['haloperidol', 'asenapine', 'asenapine'] | ['C1CN(CCC1(C2=CC=C(C=C2)Cl)O)CCCC(=O)C3=CC=C(C=C3)F', 'CN1CC2C(C1)C3=C(C=CC(=C3)Cl)OC4=CC=CC=C24', 'CN1CC2C(C1)C3=C(C=CC(=C3)Cl)OC4=CC=CC=C24'] | Inclusion Criteria: - Completed the short-term 041023 trial (NCT00156104) - Continued to meet all demographic and procedural inclusion criteria of the short-term trial upon entry into this long-term extension trial - Sign a written informed consent for the 041513 trial. - Demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator Exclusion Criteria: - CGI-S (Clinical Global Impressions of Severity of Illness) score of greater than or equal to 6 (severely psychotic) - Occurrence(s) of AEs (adverse events) or other clinically significant findings that would prohibit their continuation - Met any of exclusion criteria regarding medical/psychiatric status listed in the 041023 short-term trial - Met exclusion criteria for medication status in short-term trials except for antidepressants and mood stabilizers. | |
| 41 | NCT00397241 | completed | 1 | phase 4 | ['open-angle glaucoma'] | ["['H40.10X0', 'H40.10X1', 'H40.10X2', 'H40.10X3', 'H40.10X4', 'H40.1130', 'H40.1131']"] | ['drug: dorzolamide/timolol', 'drug: latanoprost/timolol', 'dorzolamide/timolol and latanoprost', 'placebo (artificial tears)'] | ['Status: 400', 'Status: 503'] | Inclusion Criteria: - Consecutive primary open-angle (POAG) and exfoliative glaucoma (XFG) patients will be recruited. - Patients included will be older than 29 years - Have early to moderate POAG, or XFG (less than 12 mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio) - Will be on therapy with latanoprost for more than 3 months; - Have at treated baseline IOP at 10:00 (two consecutive readings) greater than 21 mm Hg - Have a reliable visual field (at least two visual fields with less than 30% fixation losses, false positives or negatives) - Have a best corrected distance Snellen visual acuity > 1/10 - Have corneal pachymetry within the 550 ± 55 μm range, understand the study instructions and are willing to attend all follow-up appointments - Are willing to comply with study medication usage - And have open, normal appearing angles Exclusion Criteria: - Patients will be excluded if they have: a risk for significant deterioration during the study - Known previous history of lack of adequate response (< 10% reduction) to any topical glaucoma medication - Less than 20% daytime IOP reduction on latanoprost; - Systemic contraindications to topical beta-blockers (asthma, bradycardia, severe congestive heart disease) - Known contraindications to prostaglandins, history of ocular herpetic disease, or cystoid macular edema - History of trauma, inflammation, surgery or past use of steroids (within two months) - Severe dry eyes - Use of contact lenses - Signs of ocular infection, except blepharitis - Corneal abnormality that may affect IOP measurements - Unwillingness to accept the risk for hyperchromia of the iris or development of hypertrichosis - And females of childbearing potential or lactating mothers | |
| 42 | NCT00325182 | completed | 1 | phase 4 | ['alcoholism'] | ["['Z63.72']"] | ['levetiracetam'] | ['CCC(C(=O)N)N1CCCC1=O'] | Inclusion Criteria: - DSM IV TR Diagnosis of Alcohol Dependence - Male or female age 21-60 years old - Able to provide informed consent and comprehend study procedures - Negative urine toxicological screen for narcotics, amphetamines, sedative hypnotics and cannabinoids. The test may be repeated within a week. - Score of > 8 on Alcohol Use Disorder Identification Test during screening - Must be suitable for outpatient management - Express desire to stop drinking or reduce alcohol consumption with possible long-term goal of abstinence. - Provide contact information for themselves or an alternate contact that the study staff will contact in case of missed appointment. - Female subjects must be postmenopausal for at least one year, or practicing an effective method of birth control before entry and throughout the study - Must be able to take oral medications, adhere to regimen and be willing to return for follow up visits - Must have breath alcohol concentration of no more than 0.025% when signing the informed consent Exclusion criteria: - Dependent on or extensive abuse of drugs or substances other than ethanol, nicotine or caffeine - DSM IV- TR diagnosis of any current Axis I diagnosis other than alcohol, nicotine or caffeine dependence that in the investigator's judgment might require intervention with either pharmacological or non-pharmacological therapy that might interfere with the course of the study - Receiving inpatient or outpatient treatment for alcohol dependence (with the exception of AA or other self-help groups) within the 4 weeks prior to enrollment - Subjects with a score of 10 or greater on the CIWA-Ar at visits one and two - Currently being treated with disulfiram or naltrexone - Currently being treated with any the following medications: a) Antipsychotic agent [b) Lithium Carbonate c) Anticonvulsant agent d) Hypnotics e) Antianxiety Agents f) Chronic opiate treatment with methadone, laam, buprenorphine; oxycodone, morphine, etc g) Stimulant treatment - Subjects who are legally mandated to participate in alcohol treatment program - Subjects who have had a suicide attempt or suicidal ideation within 30 days of the first visit - Subjects with renal disease - Subjects with AST and ALT >3 times the upper limit of the normal range during screening. Test may be repeated prior to enrollment. If repeat lab values are all within acceptable ranges subject may continue study participation. - Major neurological disorder including seizures - Subjects who are pregnant or lactating - Subjects known to have clinically significant medical conditions, including, but not limited to: symptomatic CAD or PVD, malignancy or history of malignancy in the last 5 years, pulmonary disorders, endocrinological disorders - Subjects with prior hypersensitivity to Keppra - Subjects with history of medically complicated withdrawal from alcohol. - Subjects who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings and contraindications outlined in the Keppra package insert - Subjects with cardiac pacemaker or metal surgical implant | |
| 43 | NCT01181102 | completed | 1 | phase 3 | ['venous thromboembolism'] | ["['O88.22', 'O88.23', 'O88.211', 'O88.212', 'O88.213', 'O88.219']"] | ['edoxaban', 'enoxaparin sodium'] | ['CN1CCC2=C(C1)SC(=N2)C(=O)NC3CC(CCC3NC(=O)C(=O)NC4=NC=C(C=C4)Cl)C(=O)N(C)C', 'CC1C(C(OC(C1OC2CC(C(C(C2O)O)OC3C(C(C(C(O3)COS(=O)(=O)O)OC4C(C(C=C(O4)C(=O)[O-])O)O)O)NC(=O)C)C(=O)[O-])CO)OC5C(C(C(OC5C(=O)[O-])OC6C7COC(O7)C(C6O)NS(=O)(=O)[O-])O)O)NC(=O)C.[Na+].[Na+].[Na+].[Na+]'] | Inclusion Criteria: - Patients undergoing unilateral total knee arthroplasty Exclusion Criteria: - Subjects with risks of hemorrhage - Subjects with thromboembolic risks - Subjects who weigh less than 40 kg - Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant. | |
| 44 | NCT01688037 | completed | 0 | phase 2 | ['tardive dyskinesia'] | ["['K22.4', 'G24.01']"] | ['nbi-98854', 'nbi-98854', 'placebo'] | ['Status: 503', 'Status: 503', 'Status: 503'] | Inclusion Criteria: - Have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia for at least 3 months prior to screening. - Be receiving a stable dose of antipsychotic medication for a minimum of 30 days before study start. Subjects who are not using antipsychotic medication must have stable psychiatric status. - Have the doses of concurrent medications and the conditions being treated be stable for a minimum of 30 days before study start and be expected to remain stable during the study. - Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study. - Female subjects must not be pregnant. - Be in good general health and expected to complete the clinical study as designed. - Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive). - Have a negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and study start, except for any subject receiving a stable dose of benzodiazepine. - Have a negative alcohol breath test at screening and study start. Exclusion Criteria: - Have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening. - Have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start(nicotine and caffeine dependence are not exclusionary). - Have a known history of neuroleptic malignant syndrome. - Have a significant risk of suicidal or violent behavior. - Receiving any excluded concomitant medication such as reserpine, metoclopramide, stimulants, or tetrabenazine. - Receiving medication for the treatment of tardive dyskinesia. - Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a history of positive result. - Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study. - Have an allergy, hypersensitivity, or intolerance to tetrabenazine. - Have had previous exposure with NBI-98854. | |
| 45 | NCT00090844 | terminated | early closure due to low accrual | 0 | phase 2 | ['breast cancer', 'hormone changes', 'drug toxicity'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['triptorelin'] | ['CC(C)CC(C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NCC(=O)N)NC(=O)C(CC2=CNC3=CC=CC=C32)NC(=O)C(CC4=CC=C(C=C4)O)NC(=O)C(CO)NC(=O)C(CC5=CNC6=CC=CC=C65)NC(=O)C(CC7=CN=CN7)NC(=O)C8CCC(=O)N8'] | Inclusion Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer - Early-stage, operable disease - Scheduled to receive adjuvant or neoadjuvant systemic chemotherapy for breast cancer - Hormone receptor status: - Meets 1 of the following criteria: - Estrogen receptor (ER)- OR progesterone receptor (PR)-positive - ER- AND PR-negative - No history of premature ovarian failure PATIENT CHARACTERISTICS: Age - Under 45 Sex - Female Menopausal status - Premenopausal - Follicle-stimulating hormone levels < 40 IU/L at baseline AND at least 2 menstrual periods within the past 6 months - No first-degree relative menopausal at < 40 years of age Performance status - Eastern Cooperative Oncology Group [ECOG] 0-1 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Fertile patients must use effective non-hormonal methods of contraception - No prior osteoporosis or other non-malignant systemic disease that would preclude prolonged follow-up - No known allergies to gonadotrophin-releasing hormone agonists - No other cancer except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No prior chemotherapy Endocrine therapy - At least 2 weeks since prior oral contraceptives - No prior fertility treatment - Clomiphene or pergonal for polycystic ovarian disease allowed - No other concurrent oral or transdermal hormonal therapy, including any of the following: - Estrogen - Progesterone - Androgens - Aromatase inhibitors - Hormone replacement therapy - Oral contraceptives Radiotherapy - No prior ovarian radiotherapy Surgery - No prior bilateral oophorectomy - No plans for oophorectomy or hysterectomy within the next 2 years Other - At least 1 week since prior warfarin Exclusion Criteria: - History of premature ovarian failure - Over 45 years of age - First-degree relative menopausal at < 40 years of age - Pregnant or nursing - Prior osteoporosis or other non-malignant systemic disease that would preclude prolonged follow-up - Known allergies to gonadotrophin-releasing hormone agonists - Other cancer besides nonmelanoma skin cancer - Prior chemotherapy - Prior ovarian radiotherapy - Prior bilateral oophorectomy |
| 46 | NCT02416271 | completed | 1 | phase 4 | ['osteoporosis'] | ["['M81.6', 'Z82.62', 'Z13.820', 'M81.8', 'Z87.310', 'M81.0', 'M80.80XS']"] | ['teriparatide', 'alendronate', 'placebo-oral', 'placebo-sc'] | ['CCC(C)C(C(=O)NC(CCC(=O)N)C(=O)NC(CC(C)C)C(=O)NC(CCSC)C(=O)NC(CC1=CNC=N1)C(=O)NC(CC(=O)N)C(=O)NC(CC(C)C)C(=O)NCC(=O)NC(CCCCN)C(=O)NC(CC2=CNC=N2)C(=O)NC(CC(C)C)C(=O)NC(CC(=O)N)C(=O)NC(CO)C(=O)NC(CCSC)C(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(CC3=CNC4=CC=CC=C43)C(=O)NC(CC(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CCC(=O)N)C(=O)NC(CC(=O)O)C(=O)NC(C(C)C)C(=O)NC(CC5=CNC=N5)C(=O)NC(CC(=O)N)C(=O)NC(CC6=CC=CC=C6)C(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CO)NC(=O)C(C(C)C)NC(=O)C(CO)N', 'C(CC(O)(P(=O)(O)O)P(=O)(O)O)CN'] | Inclusion Criteria: - Postmenopausal women with osteoporosis. - Ambulatory, 5 years or more past menopause. - BMD T score between -2.5 and -4.0 at the lumbar spine or femoral neck. - Normal or clinically insignificant abnormal laboratory values, including serum calcium, parathyroid hormone (PTH) 1-84, 25-hydroxyvitamin D, and alkaline phosphatase. Exclusion Criteria: - Prior treatment with PTH or a PTH analogue. - Treatment with bisphosphonates within 12 months, anabolic corticosteroids or calcitriol or vitamin D analogues or agonists within 6 months, estrogens or selective estrogen receptor modulators within 3 months, or calcitonin within 2 months; therapeutic doses of fluoride; systemic corticosteroid use within 1 month or for more than 30 days in the prior year; use of anticoagulants within 1 month. - History of diseases other than postmenopausal osteoporosis that affect bone metabolism. - History of an increased risk of osteosarcoma (ie, patients with Paget disease of bone, previous skeletal exposure to external beam radiotherapy, or previous malignant neoplasm involving the skeleton). - Malignant neoplasms within 5 years; carcinoma in situ of the uterine cervix within 1 year. - Nephrolithiasis or urolithiasis within 2 years, or impaired renal function. - Abnormal uncorrected thyroid function. - Liver disease or clinical jaundice. - Alcohol or other drug abuse. - Poor medical or psychiatric risk for treatment. | |
| 47 | NCT00697281 | completed | 0 | phase 2 | ['allergic rhinitis'] | ["['J30.89', 'J30.9', 'J30.2', 'J30.1', 'J30.5', 'J30.81']"] | ['oc000459', 'oc000459', 'oc000459', 'oc000459', 'placebo'] | ['CC1=C(C2=C(N1CC(=O)O)C=CC(=C2)F)CC3=NC4=CC=CC=C4C=C3', 'CC1=C(C2=C(N1CC(=O)O)C=CC(=C2)F)CC3=NC4=CC=CC=C4C=C3', 'CC1=C(C2=C(N1CC(=O)O)C=CC(=C2)F)CC3=NC4=CC=CC=C4C=C3', 'CC1=C(C2=C(N1CC(=O)O)C=CC(=C2)F)CC3=NC4=CC=CC=C4C=C3'] | Inclusion Criteria: - Males and females aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years. - Females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception and must have a negative pregnancy test (blood or urine) at screening. - Acceptable contraception includes the use of TWO of the following: - oral contraception (i.e. the Pill); - intrauterine device (an IUD or 'Coil'); - barrier contraception (i.e. condoms or diaphragm/cap); - transdermal patch Exclusion Criteria: - Medical conditions likely to affect the outcome of the study. - Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases as determined by the principal investigator or designee. - Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as FEV1 ≥ 90% predicted for height and age). - Immunotherapy treatment course in the past 28 days - Use of inhaled or local corticosteroids in the past 28 days. | |
| 48 | NCT01447706 | completed | 0 | phase 2 | ['epithelial ovarian cancer', 'fallopian tube cancer', 'peritoneal cancer'] | ["['H18.523', 'H18.521', 'H18.522', 'H18.529']", "['C57.00', 'C57.01', 'C57.02']", "['K65.1', 'K66.0', 'N99.4', 'N73.6', 'R88.0', 'Z49.32', 'Z49.02']"] | ['mm-121', 'paclitaxel'] | ['Status: 503', '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: - Locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer - Received at least one prior platinum based chemotherapy regimen - Platinum-resistant or refractory - Eligible for weekly paclitaxel - Adequate liver and kidney function - 18 years of age or above Exclusion Criteria: - Evidence of any other active malignancy - History of severe allergic reactions to paclitaxel or other drugs formulated in Cremophor®EL | |
| 49 | NCT00378833 | completed | 1 | phase 3 | ['hypercholesterolemia', 'hyperlipidemia'] | ["['E78.01', 'E78.00', 'Z83.42']", "['E78.2', 'E78.49', 'E78.5']"] | ['niacin (+) laropiprant', 'niacin'] | ['C1=CC(=CN=C1)C(=O)O'] | Inclusion Criteria: - Patient is an appropriate candidate for niacin therapy (at risk for heart disease) and triglycerides < 500 mg/dL Exclusion Criteria: - Patients with a history of any cardiovascular event directly linked to atherosclerosis with a low density lipoprotein-cholesterol (LDL-C) >/= 130 mg/dL and/or not on a statin - Patients with diabetes and LDL-C >/= 130 mg/dL. Patients with >/= 2 heart disease risk factors and LDL-C >/= 160 mg/dL. - Patients who have had a cardiovascular event (e.g., heart attack, stroke) within the previous 3 months. | |
| 50 | NCT01187615 | terminated | 0 | phase 1 | ['small cell lung carcinoma'] | ["['D02.20', 'D02.21', 'D02.22']"] | ['regorafenib (bay73-4506) - sequential / cisplatin / pemetrexed', 'regorafenib (bay73-4506) - continuous / cisplatin / pemetrexed'] | ['Status: 503'] | Inclusion Criteria: - Age >= 18 years. - Histological or cytological diagnosis of metastatic Stage IV or locally advanced, unresectable confirmed Stage IIIB nonsquamous Non-Small Cell Lung Cancer (NSCLC) not amenable to local therapy with curative intent. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2 - Life expectancy of at least 12 weeks. - Adequate bone marrow, liver, and renal function - Controlled blood pressure [defined as systolic Blood Pressure (BP) <=150 mmHg and diastolic Blood Pressure (BP) <= 90 mmHg] - Men and women of childbearing potential enrolled in this study must use adequate barrier birth control measures during the course of the study Exclusion Criteria: - Sensory neuropathy with sensory alterations or paresthesia (including tingling), interfering with function - Hearing impairment - Persistent proteinuria of Common Toxicity Criteria (CTC) Grade 3 or higher - Cardiac disease: congestive heart failure > New York Heart Association (NYHA) Class II; 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; cardiac ventricular arrhythmias requiring anti-arrhythmic therapy - Brain metastasis: patients with neurological symptoms should undergo a Computerized Tomography (CT) scan / Magnetic Resonance Imaging (MRI) of the brain to exclude any new or progressive brain metastasis. Patients with brain metastases are excluded from the trial - Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication - Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 4 weeks prior to the start of study treatment. Clinically significant hemoptysis (1 teaspoon or more) in the past 3 months - Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks prior to the start of study treatment - Evidence or history of bleeding diathesis or coagulopathy - Centrally located tumors with radiologic evidence (CT or MRI) of local invasion of major blood vessels - The effect of third space fluid, such as pleural effusion and ascites, on pemetrexed is unknown. In patients with clinically significant third space fluid, consideration should be given to draining the effusion prior to study start - Patients with phaeochromocytoma Excluded Therapies and Medications, Previous and Concomitant - Prior treatment with a systemic chemotherapy for metastatic NSCLC. Patients who underwent prior systemic treatment or radiotherapy for NSCLC in a neoadjuvant or adjuvant setting are eligible, but no chemotherapy treatment within the last 6 month prior to study entry is allowed | |
| 51 | NCT00595101 | completed | 0 | phase 2 | ['primary open angle glaucoma', 'ocular hypertension'] | ["['H40.1130', 'H40.1131', 'H40.1132', 'H40.1133', 'H40.1134', 'H40.1110', 'H40.1111']", "['H40.053', 'H40.051', 'H40.052', 'H40.059']"] | ['pf-03187207', 'latanoprost 0.005%', 'pf-03187207 vehicle', 'latanoprost vehicle'] | ['C1C(C(C(C1O)CC=CCCCC(=O)OCCCCO[N+](=O)[O-])CCC(CCC2=CC=CC=C2)O)O', 'Status: 503'] | Inclusion Criteria: - Man or woman at least 20 years of age - Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes. Exclusion Criteria: - Closed/barely open anterior chamber angle or a history of acute angle closure in either eye - Contraindications to latanoprost and nitric oxide treatment - Known latanoprost non-responders | |
| 52 | NCT00140452 | completed | 0 | phase 2 | ['amyotrophic lateral sclerosis', 'als'] | ["['G12.21']"] | ['thalidomide'] | ['C1CC(=O)NC(=O)C1N2C(=O)C3=CC=CC=C3C2=O'] | Inclusion Criteria: - Clinically proven ALS - Disease duration less than or equal to 5 years - ALSFRS-R score equal to or greater then 30 Exclusion Criteria: - Patients with known deep venous thrombosis or hyper coagulable state will be excluded - Patients with FVC less than 80% | |
| 53 | NCT00234000 | terminated | the study was closed due to poor enrollment | 0 | phase 1 | ['leukemia', 'myelodysplastic syndromes'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']", "['D46.9', 'D46.C', 'D46.Z']"] | ['arsenic trioxide', 'azacitidine'] | ['Status: 503', 'C1=NC(=NC(=O)N1C2C(C(C(O2)CO)O)O)N'] | Inclusion Criteria: - Confirmed diagnosis of MDS by standard criteria. Patients within each of the FAB diagnostic groups of RA, RARS, RAEB, RAEBt, and CMML are eligible. For patients with lower-risk MDS only: documented red blood cell dependence, defined as the inability to maintain a hematocrit of > 25% without transfusion support. - Adequate marrow iron stores - In patients with serum erythropoietin less than 200 IU/mL at screening, failure to have responded to a 2 to 3 month trial of recombinant erythropoietin - Serum creatinine or serum bilirubin < 1.5 times the upper limit of normal; higher levels are acceptable if ALT levels < 2 x upper limits of normal - Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine/treatment. - Women of childbearing potential should be advised to avoid becoming pregnant and should be advised to not father a child while receiving treatment with azacitidine - Age > 18 years Exclusion Criteria: - Treatment with growth factors within the 30 days before first treatment with ATO/Azacitidine, except that patients with serum erythropoietin < 200 IU/mL who failed to respond to a trial with EPO are not excluded regardless of the time since last EPO - Treatment with cytotoxic or experimental agents within 30 days before first treatment with ATO/Azacitidine - Absolute QT interval > 460 msec in the presence of adequate serum potassium and magnesium values - Active serious infections that are not controlled by antibiotics - Pregnant or lactating women - Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests - NYHA Class III or IV heart failure - Poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol |
| 54 | NCT00605293 | completed | 1 | phase 3 | ['anemia'] | ["['D53.2', 'D64.9', 'D46.4', 'D53.0', 'D53.9', 'D61.3', 'D61.9']"] | ['methoxy polyethylene glycol-epoetin beta', 'epoetin alfa'] | ['CC1CC=CC=CC(C(CC(C(C(C(CC(=O)O1)O)OC)OC2C(C(C(C(O2)C)OC3CC(C(C(O3)C)O)(C)O)N(C)C)O)CCO)C)OC4CC(C(C(O4)C)O)(C)O'] | Inclusion Criteria: - chronic renal anemia; - continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP; - regular hemodialysis for greater than or equal to (>=) 3 months Exclusion Criteria: - transfusion of red blood cells during previous 2 months - poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months; | |
| 55 | NCT01104766 | completed | 1 | phase 3 | ['schizophrenia'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['cariprazine', 'aripiprazole', 'placebo'] | ['CN(C)C(=O)NC1CCC(CC1)CCN2CCN(CC2)C3=C(C(=CC=C3)Cl)Cl', 'Status: 503'] | Inclusion Criteria: - Patients who have provided informed consent prior to any study specific procedures - Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) - Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG) - Current psychotic episode (schizophrenia exacerbation) < 2 weeks duration at Visit 1 - Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120 - CGI-S score ≥ 4 Exclusion Criteria: - Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders - Bipolar I and II disorder - Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders - DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study - Women who are pregnant or breast feeding | |
| 56 | NCT01440127 | terminated | unable to accrue all planned subjects in a timely fashion, but data collected will still be analyzed. | 0 | phase 1 | ['colon cancer'] | ["['C18.2', 'C18.4', 'C18.6', 'C18.7', 'C18.9', 'D12.2', 'D12.3']"] | ['metformin'] | ['CN(C)C(=N)N=C(N)N'] | Inclusion Criteria: - Histologically documented colorectal cancer - Intent to undergo disease resection or biopsy at least 7days from the treatment start date (allowing for a minimum of 5 days of treatment plus 2 days break) - Medically fit for resection of their primary tumor or for biopsy - Age 18-79 years - Adequate renal function (serum creatinine levels <1.5 mg/dL [males], <1.4 mg/dL [females] or estimated creatinine clearance >= 60 ml/min) - Adequate hepatic parameters, including aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, and alkaline phosphatase levels ≤ 2.5 x ULN - Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: - Intent to administer neoadjuvant chemotherapy or radiation therapy prior to the surgery or biopsy; - Intent to perform surgery or biopsy within 7 days of study treatment start; - Any situation where participation in this trial would alter, or cause significant risk of altering the ability or timing of a subject to undergo resection of their tumor - Current use of metformin (within the past month); - Blood glucose using point of care test < 70mg/dl; - Renal disease or renal dysfunction not meeting inclusion criteria; - Significant medical conditions such as cardiovascular collapse (shock), acute myocardial infarction, septicemia, acute or chronic metabolic acidosis - History of, or states associated with, lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), conditions associated with hypoxemia and pancreatitis - Severe dehydration - Clinical or laboratory evidence of hepatic disease - Congestive heart failure requiring pharmacologic treatment, or unstable or acute congestive heart failure - Known hypersensitivity to metformin hydrochloride - Pregnant or lactating women - Psychiatric illness or social situation that would limit compliance with study requirements and/or obscure results |
| 57 | NCT01207973 | terminated | 0 | phase 1 | ['osteoarthritis'] | ["['M15.4', 'M15.0', 'M16.9', 'M17.9', 'M19.011', 'M19.012', 'M19.019']"] | ['bi 113823'] | ['CC1=CC(=CC(=C1S(=O)(=O)N(C)CCOCC(=O)N(C)C2CCCC(C2)N3CCN(CC3)C)C)OC'] | Inclusion criteria patients with osteoarthritis Exclusion criteria | |
| 58 | NCT00095563 | completed | 0 | phase 2 | ['high-grade salivary gland carcinoma', 'high-grade salivary gland mucoepidermoid carcinoma', 'low-grade salivary gland carcinoma', 'low-grade salivary gland mucoepidermoid carcinoma', 'recurrent adenoid cystic carcinoma of the oral cavity', 'recurrent salivary gland cancer', 'salivary gland acinic cell tumor', 'salivary gland adenocarcinoma', 'salivary gland adenoid cystic carcinoma', 'salivary gland malignant mixed cell type tumor'] | ["['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C07', 'C08.0', 'C08.1', 'C73', 'C75.0', 'C75.1', 'C75.3']"] | ['lapatinib ditosylate'] | ['CC1=CC=C(C=C1)S(=O)(=O)O.CC1=CC=C(C=C1)S(=O)(=O)O.CS(=O)(=O)CCNCC1=CC=C(O1)C2=CC3=C(C=C2)N=CN=C3NC4=CC(=C(C=C4)OCC5=CC(=CC=C5)F)Cl'] | Inclusion Criteria: - Patients must have histologically documented or cytologically confirmed adenoid cystic, or other malignant salivary gland carcinomas of major or minor salivary gland origin; all patients must have either EGFR and/or erbB2 expressing tumors (for definitions of EGFR and erbB2 expression to be enrolled in this study; EGFR and erbB2 expression will be determined using archival paraffin samples for all study patients where possible; if these samples are unavailable then patients must undergo a biopsy to determine their EGFR and erbB2 status - Patients must have recurrent and/or metastatic disease that is progressive and not amenable to surgery or curative radiotherapy; progressive disease is defined as one of the following occurring within 6 months of study entry: - At least a 20% increase in radiologically or clinically measurable disease - Appearance of any new lesions or - Deterioration in clinical status - Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan - Patients may have had unlimited prior therapy; however, there must be at least a 4 weeks' interval between any chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy or surgery and study enrollment; exceptions may be made however, for low dose, non-myelosuppressive radiotherapy - please contact the Principal Investigator (Dr. L. Siu) PRIOR to registration if questions arise about the interpretation of this criterion; for patients who received local therapy prior to study entry, there must be either progression of measurable disease documented within the treatment field, or must have measurable disease outside the treatment field prior to study entry - Life expectancy of greater than 12 weeks - ECOG performance status 0,1, or 2 - Leukocytes >= 3,000/uL - Absolute neutrophil count >= 1,5000/uL - Platelets >= 100,000/uL - Total bilirubin within normal institutional limits - AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal - Creatinine within normal institutional limits OR - Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal - Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan: Note that baseline and on treatment scans should be performed using the same modality and preferably at the same institution - Must be willing and able to undergo tumor biopsy once before and once during investigational therapy; patients must have tumor lesions accessible for biopsy for correlative studies; the decision regarding the safety of doing a biopsy will be made by an interventional radiologist rather than the investigator and must be documented in writing; in cases where there is a medical contraindication to tumor biopsy, exception may be granted only upon discussion with the principal investigator - Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of GW572016 will be determined following review of their use by the principal investigator; a list of medications and substances known or with the potential to interact with CYP450 isoenzymes is provided in: Cytochrome P-450 Enzymes and Drug metabolism; in: Lacy CF, Armstrong LL, Goldman MP, Lance LL eds; Drug Information Handbook 8TH ed. Hudson, OH; LexiComp Inc. 2000: 1364-1371 - HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with GW572016; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated - Patients requiring oral anticoagulants (coumadin, warfarin) are eligible provided there is increased vigilance with respect to monitoring INR; if medically appropriate and treatment available, the investigator may also consider switching these patients to LMW heparin, where an interaction with GW572016 is not expected - Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately - Ability to understand and the willingness to sign a written informed consent document - Able to swallow and retain oral medication; alternately, for patients who require feeding via nasogastric tubes or who cannot swallow whole tablets, study entry is allowed by following instructions on drug administration Exclusion Criteria: - Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or - Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier - Patients who have had prior treatment with EGFR or erbB2 targeting therapies - Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy - Patients with known brain metastases but have remained stable for at least 3 months since completion of radiotherapy or surgery, have no significant neurological deficits, and are off corticosteroids, may be allowed on study; patients with symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events - Patients with a history of other active malignancy in the past 5 years (with the exception of adequately treated cervical carcinoma in situ and non-melanomatous skin cancers) are excluded - History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016 - 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 - Pregnant women are excluded from this study because GW572016 is member of the 4-anilinoquinazoline class of kinase inhibitors with the potential for teratogenic or abortifacient effects; breastfeeding should be discontinued if the mother is treated with GW572016 - HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study - Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis) - Concomitant requirement for medication classified as CYP3A4 inducer or inhibitor | |
| 59 | NCT00566501 | completed | 1 | phase 3 | ["alzheimer's disease"] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['donepezil'] | ['Status: 503'] | Inclusion Criteria for Participants: 1. Written informed consent from the participant (if possible) or from the participant's legal guardian or other representative at the time of the Baseline visit, prior to beginning any assessments or activities. 2. Completion of study E2020-G000-326 (NCT00478205) without ongoing SAEs or history of serious adverse drug reactions during study E2020-G000-326 (NCT00478205). 3. Participant must enroll in the present study within 3 days of completion of study E2020-G000-326 (NCT00478205). 4. Health: physically healthy and ambulatory or ambulatory-aided (that is, walker or cane); corrected vision and hearing sufficient for compliance with testing procedures. 5. Co-morbid medical conditions must be well-controlled as determined by the investigator. 6. Participants undergoing treatment with selective serotonin reuptake inhibitors (SSRIs) may be included, provided that doses are within the approved dose range as specified in the Physician's Desk Reference or local equivalent 7. Concomitant Medications: Participants undergoing treatment with the following medications may be enrolled in the study provided the following conditions are met: chronic daily benzodiazepine use if doses are stable within an approved dose range; bronchodilator medications for treatment of chronic obstructive pulmonary disease (COPD) as long as drug is administered via metered dose inhaler within approved dose range; memantine if taken at doses of 20 mg/day or less, provided that the dose is stable. 8. The participants must have a relative/caregiver who supervises the regular taking of the drug at the correct dose and is alert for possible side effects, unless the participant's legal guardian takes on this task. Inclusion Criteria for Caregivers. Written informed consent will be obtained from the designated caregiver for participation in study assessments. The caregiver must be sufficiently familiar with the participant (as determined by the investigator) to provide accurate data. Specifically, the caregiver must have sufficient contact with the participant to provide accurate reports of the participant's functioning, must be able to observe for possible adverse events, and must be able to accompany the participant to all visits. It is preferable that the caregiver be the same as in study E2020-G000-326 (NCT00478205). If no replacement caregiver is available who meets the caregiver inclusion/exclusion criteria, the participant must be discontinued from the study. Exclusion Criteria for Participants: 1. No caregiver available to meet the inclusion criteria for caregivers. 2. Participants with any active or clinically-significant conditions affecting absorption, distribution, or metabolism of the study medication (example, inflammatory bowel disease, gastric or duodenal ulcers, hepatic disease, or severe lactose intolerance). 3. Known plan for elective surgery during the study period that would require general anesthesia and administration of neuromuscular blocking agents, such as succinylcholine, to induce paralysis/muscle relaxation. Minor surgery, such as colonoscopy or cataract surgery, will be permitted as long as it does not require the use of these paralytic agents. 4. Participants who are unwilling or unable to fulfill the requirements of the study. 5. Use of any prohibited prior or concomitant medications. 6. Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study. 7. Participant taking concomitant antidepressant medication known to have significant anticholinergic effects, such as tricyclic antidepressants prescribed at doses recommended for the treatment of major depression. 8. Participants who cannot swallow or who have difficulty swallowing whole tablets. 9. Participants taking any alternative medication such as vitamins and/or herbal products or alternative medical techniques such as acupuncture or acupressure specifically for the treatment of Alzheimer's disease. Exclusion Criteria for Caregivers. 1. Caregivers who are unwilling or unable to give informed consent or otherwise to fulfill the requirements of the study. 2. Any condition that would make the caregiver, in the opinion of the investigator, unsuitable for the study. | |
| 60 | NCT00556933 | completed | 1 | phase 4 | ['end-stage renal disease'] | ["['N18.6', 'I12.0', 'I13.11', 'I13.2']"] | ['rabbit anti-thymocyte globulin', 'mycophenolate mofetil', 'rabbit anti-thymocyte globulin', 'sirolimus', 'tacrolimus'] | ['Status: 503', 'Status: 503', 'Status: 503', 'Status: 503', 'Status: 503'] | Inclusion Criteria: - Primary renal transplant recipient for end-stage renal disease Exclusion Criteria: - Recipient age < 18 years or > 65 years - Previous history of CMV disease - Hepatitis B and C recipients - Primary disease states that require steroids for immunosuppression - Re-transplant with immunological cause of renal or pancreas loss - Non heart beating donors - Recipient of pediatric en bloc kidneys - Recipient with a Panel Reactive Antibody (PRA) score >75% - Patients who have received 3 or more prior transplants, excluding pancreas - Patients who are past recipients of other solid organ transplants - Previous history of BK virus - Previous treatment with Thymoglobulin - Allergy to rabbits - Simultaneous Kidney/Pancreas transplantation | |
| 61 | NCT01318694 | completed | 1 | phase 3 | ['hepatitis c'] | ["['B18.2', 'B17.10', 'B17.11', 'B19.20', 'B19.21', 'B15.0', 'B15.9']"] | ['alisporivir', 'peginterferon alfa-2a', 'ribavirin', 'alv placebo'] | ['CCC1C(=O)N(C(C(=O)N(C(C(=O)NC(C(=O)N(C(C(=O)NC(C(=O)NC(C(=O)N(C(C(=O)N(C(C(=O)N(C(C(=O)N(C(C(=O)N1)C(C(C)CC=CC)O)C)C(C)C)C)CC(C)C)C)CC(C)C)C)C)C)CC(C)C)C)C(C)C)C(C)C)CC)C)C', 'C1=NC(=NN1C2C(C(C(O2)CO)O)O)C(=O)N'] | Inclusion criteria: - Chronic HCV infection - HCV genotype 1 - No previous treatment for hepatitis C infection - Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit - Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6 months Exclusion criteria: - HCV genotype different from genotype 1 or co-infection with other HCV genotype - Co-infection with Hepatitis B or HIV - Any other cause of relevant liver disease other than HCV - Presence or history of hepatic decompensation - Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN), more than 1 episode of elevated bilirubin (> ULN) in past 6 months Other protocol-defined inclusion/exclusion criteria may apply. | |
| 62 | NCT00702949 | completed | 1 | phase 3 | ['breast cancer', 'hot flashes'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['pregabalin'] | ['CC(C)CC(CC(=O)O)CN'] | DISEASE CHARACTERISTICS: - Meeting 1 of the following criteria: - History of breast cancer (currently without malignant disease) - No history of breast cancer, but patient wishes to avoid estrogen due to a perceived increased risk of breast cancer - Bothersome hot flashes (defined by their occurrence ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention) - Presence of hot flashes for ≥ 1 month prior to study entry PATIENT CHARACTERISTICS: - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Life expectancy ≥ 6 months - Able to complete questionnaire(s) by themselves or with assistance - Women of childbearing potential not eligible (per the judgment of the attending clinician) - Serum creatinine ≤ 1.5 times upper limit of normal PRIOR CONCURRENT THERAPY: - No prior gabapentin or pregabalin - More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, or progestational agents - Vaginal estrogen is allowed if used for the past month and not planned to be discontinued - Concurrent adjuvant targeted therapy (i.e., lapatinib, trastuzumab [Herceptin®]) allowed in patients with no evidence of disease - Concurrent tamoxifen, raloxifene, or aromatase inhibitors on a constant dose for at least 4 weeks allowed provided the medication will not be stopped during the study period - No concurrent or planned use of other agents for hot flashes except for any of the following: - Stable dose of vitamin E is allowed as long as agent was started > 30 days prior to study initiation and is to be continued throughout the study period - Soy is allowed, if it is planned to be continued at the same dose during the study period - Stable dose of antidepressants is allowed as long as it was started > 30 days prior to study initiation and is to be continued at a stable dose throughout the study period | |
| 63 | NCT00843310 | terminated | due to slow accrual | 0 | phase 2 | ['multiple myeloma'] | ["['C90.01', 'C90.02', 'C90.00']"] | ['lenalidomide (revlimid)', 'melphalan', 'dexamethasone'] | ['C1=CC(=CC=C1CC(C(=O)O)N)N(CCCl)CCCl', 'CC1CC2C3CCC4=CC(=O)C=CC4(C3(C(CC2(C1(C(=O)CO)O)C)O)F)C'] | Inclusion Criteria: - Newly Diagnosed multiple myeloma, ISS stage I-III requiring therapy: Serum M-protein ≥1 gm/dL (≥10 gm/L), Urine M-protein ≥200 mg/24 hr, Serum FLC assay: involved FLC ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal - Previously untreated except prior treatment with corticosteroid less than one full cycle of pulsed dose dexamethasone (40 mg daily days 1-4, 9-12, and 17-20) or equivalent is allowed. Concomitant administration of IV bisphosphonates, Zometa (zoledronic acid, up to 4 mg IVSS over 30 minutes every four weeks) or Aredia (alendronate, up to 90 mg IVSS over 4 hours every four weeks), for prophylaxis against skeletal complications due to lytic bone disease or for acute management of hypercalcemia is allowed. Concomitant external beam radiation therapy for local management of lytic bone disease is allowed. - Age ≥ 18 years old - Life expectancy ≥ 12 weeks - Eastern Cooperative Oncology Group (ECOG) Performance Status will be employed. ECOG 0-2 accepted. - WBC ≥ 3.0 X 103/ µL, ANC ≥ 1.5 X 103/ µl, Hgb ≥ 8.0 gm/ dL, Plt ≥ 75 X 103/ µl, Serum Creatinine ≤ 2.0 mg/ dL - Ability to understand and the willingness to sign a written informed consent document. - All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®. - Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods. - Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin). Exclusion Criteria: - Prior therapy with Revlimid®, Thalomid (thalidomide), Velcade (bortezomib), Alkeran (melphalan) excluded. Prior therapy with corticosteroid allowed as defined in inclusion criteria. - No prior or concurrent treatment with an investigational agent. - Active Hepatitis B or C excluded, New York Heart Association grade III/IV congestive heart failure excluded, History of bleeding disorder excluded, History of platelet function disorder, History of deep vein thrombosis or other thromboembolic event excluded - Prior history of allergic reaction to IMiD™ compounds (Thalidomide, Lenalidomide) excluded. - Concomitant treatment with nonsteroidal antiinflammatory drugs (NSAIDs)(with the exception of aspirin) or other nephrotoxic agents is excluded. - Serum creatinine > 2.0 mg/ dL is excluded - Pregnancy and breastfeeding excluded - Known HIV+ patients are excluded. - Other active hematologic or solid tumor or history of such disease requiring therapy of any form within five years of screening is excluded. |
| 64 | NCT01224067 | completed | 1 | phase 4 | ['social anxiety disorder'] | ["['F20.81', 'F21', 'F34.0', 'F34.1', 'F42.3', 'F45.0', 'F51.5']"] | ['quetiapine'] | ['Status: 503'] | Inclusion Criteria: - Male and female outpatients, age 18-65. - Diagnosis of Social Anxiety Disorder (SAD), generalized subtype, by DSM-IV criteria. - Liebowitz Social Anxiety Scale (LSAS) rating greater than or equal to 50 for both phases. - Hamilton Depression Scale (HAM-D-17) score less than or equal to 16. Exclusion Criteria: - Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months). - Patients with current or history of bipolar disorder, schizophrenia, or other psychotic conditions. - Patients with a history of alcohol or substance abuse or dependence within the last six months or a positive toxicology screen consistent with abuse at baseline. - Patients with significant unstable medical illness, including any medical pathology considered not well-controlled with conventional treatment, i.e., that may require during the study period medication adjustment, ongoing tests or procedures, intensive treatment or hospitalization. In addition, baseline laboratory tests will be conducted and required to be within normal limits or have no clinical significance for patient entry in the study. - Severe personality disorders likely to interfere with study participation or who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk. - Ongoing psychotherapy directed toward the treatment of social anxiety disorder. - History of hypersensitivity to sertraline and quetiapine. | |
| 65 | NCT00639158 | completed | 1 | phase 3 | ['dyslipidemias', 'coronary heart disease', 'combined (atherogenic) dyslipidemia', 'mixed dyslipidemia'] | ["['I25.10', 'I25.110', 'I25.112', 'I25.119', 'I25.111', 'I25.118']", "['D81.89', 'D81.9', 'F90.2', 'Z73.812', 'D81.0', 'H25.813', 'D81.31']"] | ['abt-335', 'placebo', 'atorvastatin', 'ezetimibe'] | ['CC(C)(C(=O)[O-])OC1=CC=C(C=C1)C(=O)C2=CC=C(C=C2)Cl.C[N+](C)(C)CCO', 'Status: 503', 'C1=CC(=CC=C1C2C(C(=O)N2C3=CC=C(C=C3)F)CCC(C4=CC=C(C=C4)F)O)O'] | Inclusion Criteria: - Subjects with mixed dyslipidemia (trigylcerides, > or = to 150 mg/dL to < 400 mg/dL; HDL-C < 40 mg/dL for males, < 50 mg/dL for females; LDL-C, > or = to 130 mg/dL). - Subjects must agree to use adequate birth control methods and to adhere to the American Heart Association (AHA) Diet. Exclusion Criteria: - Subjects with unstable or uncontrolled medical conditions considered inappropriate in a clinical trial. - Subjects with an unstable dose of medications or receiving Coumadin, oral, intravenous or intramuscular cyclosporine, statins, or certain other medications. - Women who are pregnant or plan on becoming pregnant, or women who are lactating. | |
| 66 | NCT00103922 | completed | 1 | phase 3 | ['pulmonary disease, chronic obstructive'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['cilomilast'] | ['COC1=C(C=C(C=C1)C2(CCC(CC2)C(=O)O)C#N)OC3CCCC3'] | Inclusion criteria: - Diagnosis of COPD and a history of cigarette smoking. Exclusion criteria: - Significant heart or lung disease not associated with COPD. - Significant stomach or intestinal disease. | |
| 67 | NCT00484198 | completed | 1 | phase 3 | ['type 2 diabetes mellitus'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['pioglitazone', 'placebo', 'rivoglitazone', 'rivoglitazone'] | ['CCC1=CN=C(C=C1)CCOC2=CC=C(C=C2)CC3C(=O)NC(=O)S3', 'CN1C2=C(C=CC(=C2)OC)N=C1COC3=CC=C(C=C3)CC4C(=O)NC(=O)S4', 'CN1C2=C(C=CC(=C2)OC)N=C1COC3=CC=C(C=C3)CC4C(=O)NC(=O)S4'] | Inclusion Criteria: - Diagnosis of type 2 diabetes - Male or female at least 18 years of age - Hemoglobin A1C > 7% and less or equal to 8.5% - Non-fasting C-peptide > 0.5 ng/mL - Current monotherapy treatment with stable dose of approved non-Thiazolidinedione (TZD) antihyperglycemic medication for greater or equal to 3 months prior to screening or - Untreated with any antihyperglycemic agent during 2 months prior to screening Exclusion Criteria: - History of type 1 diabetes or ketoacidosis - History of long-term therapy with insulin - Body Mass Index (BMI) > 45 kg/m^2 - Known history of Congestive Heart Failure (CHF) - Impaired hepatic function - History of prior treatment failure with, or intolerance of, a TZD - Contraindication to treatment with pioglitazone - Treatment with fibrates - If untreated with oral antihyperglycemic, considered to have failed diet and exercise modification as the sole treatment for type 2 diabetes | |
| 68 | NCT00244816 | completed | 0 | phase 2 | ['metastatic melanoma'] | ["['C43.0', 'C43.31', 'D03.9', 'C43.51', 'C43.9', 'D03.0', 'C43.4']"] | ['taxoprexin'] | ['CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)OC(C(C1=CC=CC=C1)NC(=O)C2=CC=CC=C2)C(=O)OC3CC4(C(C5C(C(CC6C5(CO6)OC(=O)C)O)(C(=O)C(C(=C3C)C4(C)C)OC(=O)C)C)OC(=O)C7=CC=CC=C7)O'] | Inclusion Criteria: 1. Patients must have histologic or cytologic confirmation of malignant eye melanoma, and documented metastatic disease. 2. Patients must have at least one unidimensionally measurable lesion. 3. Patients may be previously untreated or may have received one prior systemic chemotherapy regimen for metastatic disease. Patients may not have been treated previously with taxanes. Prior treatment with immunotherapy or vaccine therapy is allowed. 4. At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy. 5. At least 4 weeks (28 days) since prior radiotherapy to > 20% of the bone marrow and prior adjuvant chemotherapy. 6. Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy. 7. Patients must have ECOG performance status of 0 - 2. 8. Patients must be at least 13 years of age. 9. Patients must have adequate liver and renal function. 10. Patients must have adequate bone marrow function. 11. Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution. - Exclusion Criteria: 1. Patients who have received prior therapy with any taxane. 2. Patients whose site of primary melanoma is not in the choroid(eye). 3. Patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years. 4. Patients with symptomatic brain metastasis (es). 5. Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study. 6. Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals). 7. Patients with current peripheral neuropathy of any etiology that is greater than grade one (1). 8. Patients with unstable or serious concurrent medical conditions are excluded. 9. Patients with a known hypersensitivity to Cremophor. 10. Patients with Gilbert's Syndrome. 11. Patients must not have had major surgery within the past 14 days. 12. Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study. 13. Known HIV disease or infection. - | |
| 69 | NCT01303536 | completed | 1 | phase 4 | ['obsessive compulsive disorder'] | ["['F42.8', 'F42.9', 'F60.5']"] | ['ondansetron'] | ['CC1=NC=CN1CC2CCC3=C(C2=O)C4=CC=CC=C4N3C'] | Inclusion Criteria: - a diagnosis of OCD established by clinical interview with a licensed psychiatrist; - a score of ≥ 24 at the Yale Brown Obsessive Compulsive Scale - a Clinical Global Inventory score ≥ 4, after over 12 weeks of treatment with an adequate trial of an selective serotonin reuptake inhibitor at a moderate to high dose Exclusion Criteria: - diagnoses of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, current substance dependence or abuse, and current major depressive episode preceding the onset of obsessive compulsive disorder - undergoing concomitant behavior therapy - or having significant cardiovascular, hepatic, renal or pulmonary diseases | |
| 70 | NCT02782845 | completed | 1 | phase 4 | ["non-hodgkin's lymphoma"] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['chemotherapy', 'immunochemotherapy', 'pegfilgrastim'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - NHL supported by an Immunohistochemical report - Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to (>/=) 2 - Total serum bilirubin less than (<) 2 times upper limit of normal (ULN) - Absolute neutrophil count (ANC) greater than (>) 2 x10^9 per liter (/L) Exclusion Criteria: - Bone marrow compromised > 10 percent (%) - Any malignant myeloid condition - Active infections requiring systemic anti-infectious therapies (antibiotics, antifungal drugs, antiviral drugs) within 72 hours prior to CT or ICT initiation - Known hypersensitivity reactions to Escherichia coli derived products - Pregnant or nursing participants. Women with childbearing potential should use a safe contraceptive method | |
| 71 | NCT00550953 | completed | 1 | phase 3 | ['hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['telmisartan+amlodipine', 'telmisartan'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: 1. Essential hypertensive patients who satisfying non-responder criteria 2. Male or Female 3. Age 20 years or older 4. Outpatient Exclusion Criteria: 1. Taking four or more anti-hypertensive medications 2. Secondary hypertension 3. Mean seated diastolic blood pressure (DBP) > 114 mmHg and/or mean seated systolic blood pressure (SBP) > 200 mmHg at Visit 1, 2, 3, or 4, or mean seated DBP < 90 mmHg at Visit 3. 4. Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias 5. Congestive heart failure patients with the New York Heart Association (NYHA) functional class III-IV 6. History of myocardial infarction or cardiac surgery within last 6 months 7. History of coronary artery bypass graft or percutaneous coronary intervention (PCI) within last 3 months 8. History of unstable angina within last 3 months 9. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve 10. History of stroke or transient ischemic attack within last 6 months 11. History of sudden exacerbation of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors, or patients with post-renal transplant or post-nephrectomy 12. Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE inhibitors 13. Known hypersensitivity to any component of the investigational drug , or a known hypersensitivity to dihydropyridine -derived drugs 14. Hepatic and/or renal dysfunction 15. Diagnosed biliary atresia or cholestasis 16. Hyperkalemia 17. Dehydration 18. Sodium deficiency 19. Chronic administration of high doses of acidic nonsteroidal anti-inflammatory drugs (NSAIDs) 20. Patients who cannot change to the restricted administration and dosage during study period 21. Pre-menopausal women who meet any one of the following 1 - 3: - Pregnant or possibly pregnant (1) - Nursing (2) - Desire to become pregnant during study period (3) 22. Drug or alcohol dependency 23. Complication of malignant tumour or a disease requiring immunosuppressants 24. Compliance of < 80% or > 120% during the run-in period 25. Receiving any investigational therapy within 3 months 26. Judged to be inappropriate by the investigator or the sub-investigator | |
| 72 | NCT01290679 | completed | 1 | phase 3 | ['hepatitis c'] | ["['B18.2', 'B17.10', 'B17.11', 'B19.20', 'B19.21', 'B15.0', 'B15.9']"] | ['placebo', 'tmc435', 'peginterferon alpha-2a or peginterferon alpha-2b (pegifnα-2a/b)', 'ribavirin (rbv)'] | ['Status: 503', 'Status: 503', 'Status: 503', 'Status: 503'] | Inclusion Criteria: - Genotype 1 hepatitis C infection (confirmed at screening) - Participant has not received any prior treatment for hepatitis C - Participant must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection - Must agree to use 2 forms of effective contraception throughout study (both males and females) Exclusion Criteria: - Infection with HIV or non genotype 1 hepatitis C - Liver disease not related to hepatitic C infection - Hepatic decompensation - Significant laboratory abnormalities or other active diseases - Pregnant or planning to become pregnant | |
| 73 | NCT00513513 | terminated | poor recruitment. | 0 | phase 2 | ['hiv infections'] | ["['Z21']"] | ['tmc114 (darunavir) / ritonavir'] | ['Status: 503'] | Inclusion Criteria: - Patients with documented HIV-1 infection - For the first 11 subjects (Panel A), screening plasma HIV-1 viral load is =10000 copies/mL and <100000 copies/mL - For the second set of 13 patients (Panel B), plasma HIV-1 viral load is =20000 copies/mL and <500000 copies/mL - Patients with CD4+ cell count above 100 cells/µl - Patients have voluntarily signed the ICF - Patients can comply with the protocol requirements - Patient's general medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial. Exclusion Criteria: - Presence of any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with some exceptions - Previous or current use of antiretroviral (ARVs/anti-HIV drugs) (including both investigational as well as commercially available ARVs indicated for the treatment of HIV-infection and ARVs for treatment of hepatitis B infection with anti-HIV activity (e.g., adefovir) - Having one of protocol listed 1 PI, NRTI, or NNRTI resistance associated mutation at screening - Patients with primary HIV infection - Female patients of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period - Any active clinically significant disease (e.g., abnormal heart function, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that are expected to compromise the patient's safety or outcome in the trial. |
| 74 | NCT00648817 | completed | 1 | phase 4 | ['hiv infections'] | ["['Z21']"] | ['tenofovir disoproxil fumarate', 'tenofovir df placebo'] | ['CC(C)OC(=O)OCOP(=O)(COC(C)CN1C=NC2=C(N=CN=C21)N)OCOC(=O)OC(C)C.C(=CC(=O)O)C(=O)O'] | Inclusion Criteria: - Subjects must have documented negative HIV serology by ELISA and P24 antigen. This will be done at the screening visit. - Subjects must be clinically well males aged between 18 to 55 years. - Adequate renal function: - Calculated creatinine clearance (CrCl) >= 100 mL/min according to the Cockcroft Gault formula: Male: [(140 - age in years) x (actual body wt in kg)]/[72 x (serum creatinine in mg/dL)]= CrCl (mL/min) - Fasting blood glucose, total cholesterol and triglycerides within normal limits - Hepatic transaminases (AST and ALT) <= 3 x upper limit of normal (ULN) - Total bilirubin <= 1.5 mg/dL - Adequate hematologic function (absolute neutrophil count >= 1,000/mm3; platelets >= 50,000/mm3; hemoglobin >= 8.0 g/dL) - Serum amylase <= 1.5 x ULN (subjects with serum amylase > 1.5 x ULN will remain eligible if pancreatic lipase is <= 1.5 x ULN) - Serum phosphorus >= 2.2 mg/dL - Sexually active males must use condoms - Life expectancy >= 1 year - The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures Exclusion Criteria: - Subjects with a waist hip ratio > 0.97 or BMI > 28 kg/m2 will be excluded - Acute or chronic hepatitis B infection (determined by positive hepatitis B surface antigen result at the screening visit) - Acute or chronic hepatitis C infection (determined by positive hepatitis C antibody result at the screening visit) - Other metabolic syndrome or disease process likely to cause marked disturbance in glucose and lipid homeostasis - Receiving on-going therapy with any of the following: - Metabolically active medications - Any lipid-lowering medication - Hormonal agents (oestrogens or androgens) - Glucocorticoids - Beta-blockers - Thiazide diuretics - Thyroid preparations - Psychotropic agents - Anabolic steroids - Megoestrol acetate - Nephrotoxic agents - aminoglycoside antibiotics - IV amphotericin B - cidofovir - cisplatin - foscarnet - IV pentamidine - other agents with significant nephrotoxic potential - Vancomycin - Oral or IV ganciclovir - Agents that inhibit or compete for elimination via active renal tubular secretion ** Probenecid - Systemic chemotherapeutic agents (i.e., cancer treatment medications) - Systemic corticosteroids - Interleukin 2 (IL 2) and other immunomodulating agents - Investigational agents Administration of any of the above medications must be discontinued at least 30 days prior to the baseline visit and for the duration of the study period. - Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication. - Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance. - Malignancy or basal cell carcinoma. - Active, serious infections requiring parenteral antibiotic therapy within 15 days prior to screening. - Prior history of significant renal or bone disease. - Subjects should avoid giving blood for the duration of this study. - Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements. | |
| 75 | NCT00554086 | completed | 0 | phase 2 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['escalating dose of casodex from 50mg daily to 150 mg daily'] | ['Status: 503'] | Inclusion Criteria: 1. Provision of written informed consent. 2. Men, over 18 years of age, with histologically-confirmed prostate cancer 3. Treatment with Zoladex (goserelin acetate) for greater than 3 months prior to Day 1 4. Serum testosterone level < 50 ng/ml 5. Current treatment with bicalutamide 50 mg daily.** 6. Two consecutive rises in PSA above a nadir value, with the absolute value of the latest PSA > 2.0 ng/ml. 7. Highest PSA level no greater than or equal to 30 ng/ml. 8. Life expectancy of greater than 1 year - Exclusion Criteria: 1. Patients may not have received prolonged anti-androgen therapy other than with bicalutamide. Patients who have received short term (2 months or less) non-steroidal anti-androgen therapy with an agent other than bicalutamide to block flare are not excluded.* 2. PSA level greater than 30 ng/ml. 3. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease which would make it undesirable for the patient to participate in the trial. 4. Subjects who have received prior chemotherapy. 5. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder. 6. Absolute neutrophil count less than 1.5 x 109/L or platelets less than 100 x 109/L. 7. Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR). 8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR. 9. Serum creatinine greater than 1.5 times - | |
| 76 | NCT01076556 | terminated | 0 | phase 1 | ['chronic lymphocytic leukemia', 'prolymphocytic leukemia', 'recurrent small lymphocytic lymphoma', 'refractory chronic lymphocytic leukemia', 'stage i chronic lymphocytic leukemia', 'stage i small lymphocytic lymphoma', 'stage ii chronic lymphocytic leukemia', 'stage ii small lymphocytic lymphoma', 'stage iii chronic lymphocytic leukemia', 'stage iii small lymphocytic lymphoma', 'stage iv chronic lymphocytic leukemia', 'stage iv small lymphocytic lymphoma'] | ["['C91.11', 'C91.12', 'C91.10']", "['C91.31', 'C91.32', 'C91.61', 'C91.62', 'C91.30', 'C91.60']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['A87.2', 'K52.832', 'D72.111', 'C91.11', 'C91.12', 'C91.10']", "['C91.11', 'C91.12', 'C91.10']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['C91.11', 'C91.12', 'C91.10']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['C91.11', 'C91.12', 'C91.10']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']", "['C91.11', 'C91.12', 'C91.10']", "['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['alvocidib hydrochloride', 'cyclophosphamide'] | ['CN1CCC(C(C1)O)C2=C(C=C(C3=C2OC(=CC3=O)C4=CC=CC=C4Cl)O)O.Cl', 'C1CNP(=O)(OC1)N(CCCl)CCCl'] | Inclusion Criteria: - Histologically confirmed chronic lymphocytic leukemia (CLL) or B-cell prolymphocytic leukemia* (PLL) arising from CLL - Patients must have documented B-cell lymphocytosis > 5 x 10^9/L at some point since initial diagnosis of CLL - Patients must have B-cells that co-express CD5 with CD19 or CD20 - Patients who do not have dim sIg or CD23 expression on their leukemia cells should be examined for cyclin D1 over-expression or t(11;14) to rule out mantle cell lymphoma - To be considered high risk, patients must meet the following criteria: - At least 1 of the following: - 17p deletion - 11q deletion - Un-mutated IgV_H (≥ 98% homology) - Age > 70 years - B_2M > 4 - AND at least 1 of the following: - Progressive or marked splenomegaly and/or lymphadenopathy - Anemia (hemoglobin < 11 g/dL) or thrombocytopenia (platelets < 100,000/mm^3) - Weight loss exceeding 10% of body weight over preceding 6 months - NCI grade 2 or 3 fatigue - Fevers > 100.5° F or night sweats for > 2 weeks without evidence of infection - Progressive lymphocytosis, with an increase exceeding 50% over a 2-month period or a doubling time of < 6 months - No other concurrent hormones, chemotherapy, or radiotherapy except for steroids for new adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes) - No requirement for chronic corticosteroids - ECOG performance status 0-2 - Creatinine ≤ 2.0 mg/dL - Bilirubin ≤ 1.5 times normal unless due to Gilbert disease, hemolysis, or disease infiltration of the liver - AST ≤ 2 times normal unless due to hemolysis or disease infiltration of the liver - Negative pregnancy test - Not pregnant or nursing - Fertile patients must use effective contraception - No secondary or other malignancy that will limit survival to < 2 years - No uncontrolled concurrent 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 - No uncompensated HIV without adequate CD4 (> 200/mm^3) and requiring HIV medication - No active hepatitis B infection - No known G6PD deficiency - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to alvocidib, cyclophosphamide, rituximab, or other agents used in this study - No prior alvocidib - No prior purine analog therapy - No more than 1 prior treatment with a biologic or alkylating agent - No other concurrent investigational agents | |
| 77 | NCT00082810 | completed | 0 | phase 2 | ['estrogen receptor-positive breast cancer', 'recurrent breast cancer', 'stage iiib breast cancer', 'stage iiic breast cancer', 'stage iv breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']", "['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['fulvestrant', 'tipifarnib'] | ['CC12CCC3C(C1CCC2O)C(CC4=C3C=CC(=C4)O)CCCCCCCCCS(=O)CCCC(C(F)(F)F)(F)F', 'CN1C=NC=C1C(C2=CC=C(C=C2)Cl)(C3=CC4=C(C=C3)N(C(=O)C=C4C5=CC(=CC=C5)Cl)C)N'] | Inclusion Criteria: - Patients must have histologically or cytologically confirmed adenocarcinoma of the breast - Patients must be postmenopausal - Patients must have stage IV disease or inoperable locally advanced disease - Patients must have ER- and/or PR-positive disease as determined by their local pathology laboratory - Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan; all sites of disease should be noted and followed - Prior hormonal therapy as adjuvant therapy and/or for metastatic disease is permitted; patients previously treated with two or more prior doses of fulvestrant are not eligible; patients who have received one prior dose of fulvestrant within 28 days are eligible so long as they meet other eligibility criteria - Patients must have ECOG performance status 0-2 (Karnofsky >= 60%) - Patients must have life expectancy of greater than 3 months - Leukocytes >= 3,000/uL - Absolute neutrophil count >= 1,500/uL - Platelets >= 100,000/uL - Total bilirubin =< 2 mg/dL - AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal - Creatinine less than or equal to 1.5 times the institutional upper limits of normal - Patients must be disease-free of prior invasive malignancies for >= 5 years with the exception of: curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix - Patients must have the ability to understand and the willingness to sign a written informed consent document - Patients who have had previous therapy with farnesyltransferase inhibitor Exclusion Criteria: - Patients who have had 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 who have had prior chemotherapy for metastatic disease are not eligible; prior adjuvant or neoadjuvant chemotherapy is allowed - Patients may not be receiving any other investigational agents - History of allergic reactions attributed to compounds of similar chemical or biologic composition to tipifarnib (R115777, Zarnestra™) or other agents used in the study (e.g., imidazoles, quinolones) - Presence of rapidly progressive, life-threatening metastases; this includes patients with extensive hepatic involvement (> 50% of the liver involved), symptomatic lymphangitic metastases, or brain or leptomeningeal involvement - Concomitant anticancer treatment with the following exceptions: (1) bisphosphonates for bone metastases, (2) a GnRH analog is permitted if the patient had progressive disease on a GnRH analog plus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be discontinued - Grade 2 or more peripheral neuropathy - 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 - HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with tipifarnib or other agents administered during the study.; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated | |
| 78 | NCT00140049 | completed | 1 | phase 4 | ['glaucoma, open angle', 'ocular hypertension'] | ["['H40.053', 'H40.051', 'H40.052', 'H40.059']"] | ['xalacom', 'cosopt'] | ['CC(C)OC(=O)CCCC=CCC1C(CC(C1CCC(CCC2=CC=CC=C2)O)O)O.CC(C)(C)NCC(COC1=NSN=C1N2CCOCC2)O', 'CCNC1CC(S(=O)(=O)C2=C1C=C(S2)S(=O)(=O)N)C.Cl'] | Inclusion Criteria: - Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening Exclusion Criteria: - Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma. - History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening | |
| 79 | NCT00521001 | completed | 0 | phase 2 | ['melanoma (skin)'] | ["['C43.51', 'C43.9', 'C43.52', 'D03.51', 'C43.8', 'Z85.820', 'D03.52']"] | ['everolimus', 'temozolomide'] | ['Status: 503', 'CN1C(=O)N2C=NC(=C2N=N1)C(=O)N'] | DISEASE CHARACTERISTICS: - Histologically confirmed melanoma with manifestations of metastatic disease. - Unresectable stage IV malignant melanoma with measurable disease - Measurable disease defined as at least one lesion with the longest diameter measured as ≥ 20 mm by CT scan or MRI scan OR ≥ 10 mm by spiral CT - No previously untreated or unstable active brain metastases within the past 3 months - No known standard therapy for this disease that is potentially curative or proven capable of extending life expectancy PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Life expectancy ≥ 12 weeks - ANC ≥ 1,500/μL - Platelet count ≥ 100,000/μL - Hemoglobin ≥ 9.0 g/dL - Alkaline phosphatase ≤ 3 times institutional upper limit of normal (ULN) - Creatinine ≤ 1.5 times ULN - AST ≤ 3 times ULN - INR ≤ 1.5 - Not pregnant or nursing - Negative pregnancy test - Fertile patients and their partners must use effective contraception during and for ≥ 8 weeks after completion of study treatment - Able to return to a NCCTG institution for follow-up - Able to forego foods high in fat content 2 hours prior to and 2 hours after administration of everolimus therapy - Able to provide blood samples for research purposes - No hypersensitivity to temozolomide, dacarbazine, or any analog of sirolimus - No history of malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only - No immunosuppression from any cause, including known HIV infection or chronic immunosuppressive therapy - No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome) - No serious medical condition that may make it unsafe for a patient to enroll in study, including any of the following: - Severely impaired lung function (FEV1 < 1 liter), unstable angina pectoris (ongoing symptoms), ongoing symptomatic congestive heart failure (i.e., NYHA class I-IV) refractory to appropriate therapy, or myocardial infarction within the past 6 months, or serious uncontrolled cardiac arrhythmia - Uncontrolled diabetes in spite of optimal therapy (i.e., a history of fasting serum glucose > 150 mg/dL) - Any active (acute or chronic) or uncontrolled infection/disorders - Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the study treatment - Liver disease (i.e., uncompensated cirrhosis or active hepatitis with elevated liver enzymes) - No bleeding diathesis - No concurrent severe condition that would make it undesirable for the patient to participate in this trial or that would jeopardize compliance with the trial PRIOR CONCURRENT THERAPY: - Must have recovered from effects of prior antineoplastic therapy - At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas) - At least 4 weeks since prior immunotherapy - At least 4 weeks since prior biologic therapy - At least 4 weeks since prior radiosurgery - At least 4 weeks since prior investigational therapy for melanoma - No prior small bowel resection that may significantly alter the absorption of everolimus - No prior sirolimus or its analogues - No prior radiotherapy to > 30% of bone marrow - No concurrent drugs that may induce CYP3A4 activity - No concurrent warfarin - No concurrent grapefruit or grapefruit juice - No concurrent use or planned use of vaccines containing live virus | |
| 80 | NCT00048230 | completed | 1 | phase 3 | ['multiple myeloma'] | ["['C90.01', 'C90.02', 'C90.00']"] | ['bortezomib'] | ['B(C(CC(C)C)NC(=O)C(CC1=CC=CC=C1)NC(=O)C2=NC=CN=C2)(O)O'] | Inclusion Criteria - Patient is of a legally consenting age, as defined by local regulations. - Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements. - Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. - Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. - Male patient agrees to use an acceptable method for contraception for the duration of the study. - Patient was previously diagnosed with multiple myeloma based on standard criteria and currently requires second-, third-, or fourth-line therapy because of PD, defined as a 25% increase in M-protein, development of new or worsening of existing lytic bone lesions or soft tissue plasmacytomas, or hypercalcemia (serum calcium >11.5 mg/dL), or relapse from CR. - Patient has measurable disease, defined as follows: - For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value (generally, but not exclusively, greater than 1 g/dL of IgG M-Protein and greater than 0.5g/dL IgA) and, where applicable, urine light-chain excretion of ≥200 mg/24 hours. - For oligo- or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan). In patients with oligosecretory multiple myeloma, the serum and/or urine M-protein measurements are very low and difficult to follow for response assessments. Therefore, other disease sites (bone marrow; extramedullary mass) must be assessed and followed. In patients with non-secretory multiple myeloma, there is no M-protein in serum or urine by immunofixation. - Patient has a Karnofsky performance status ≥60%. - Patient has a life-expectancy >3 months. - Patient has the following laboratory values at and within 14 days before Baseline (Day 1 of Cycle 1, before study drug administration): - Platelet count ≥50 x 10E+9/L without transfusion support within 7 days before the laboratory test. - Hemoglobin ≥7.5 g/dL, without transfusion support within 7 days before the laboratory test. - Absolute neutrophil count (ANC) ≥0.75 x 10E+9/L without the use of colony stimulating factors. - Corrected serum calcium <14 mg/dL (3.5 mmol/L). - Aspartate transaminase (AST): ≤2.5 x the upper limit of normal (ULN). - Alanine transaminase (ALT): ≤2.5 x the ULN. - Total bilirubin: ≤1.5 x the ULN. - Calculated or measured creatinine clearance: ≥20 mL/minute. Exclusion Criteria - Patient previously received treatment with VELCADE. - Patient previously was refractory to treatment with high-dose dexamethasone, as experiencing less than a partial response to or PD within 6 months after discontinuing dexamethasone, or discontinued dexamethasone because of ≥Grade 3 dexamethasone-related toxicity. - Previous high-dose dexamethasone therapy is defined as >500 mg dexamethasone or equivalent over a 10-week period, whether administered alone or as part of the VAD regimen. - Patient received nitrosoureas within 6 weeks or any other chemotherapy, including thalidomide or clarithromycin, or radiation therapy within 3 weeks before enrollment. - Patient received corticosteroids (>10 mg/day prednisone or equivalent) within 3 weeks before enrollment. - Patient received immunotherapy or antibody therapy within 8 weeks before enrollment. - Patient received plasmapheresis within 4 weeks before enrollment. - Patient had major surgery within 4 weeks before enrollment. (Kyphoplasty is not considered major surgery.) - Patient has a history of allergic reaction attributable to compounds containing boron or mannitol. - Patient has peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Toxicity Criteria (NCI CTC): - Grade 2: Objective sensory loss or paresthesia (including tingling), interfering with function, but not interfering with activities of daily living (ADLs). - Grade 3: Sensory loss or paresthesia interfering with ADLs. - Grade 4: Permanent sensory loss that interferes with function. - Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. - Patient was treated for a cancer other than multiple myeloma within 5 years before enrollment, with the exception of basal cell carcinoma or cervical cancer in situ. - Patient has cardiac amyloidosis. - Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol. - Patient is known to be human immunodeficiency virus (HIV)-positive. (Patients assessed by the investigator to be at risk for HIV infection should be tested in accordance with local regulations.) - Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection. - Patient has an active systemic infection requiring treatment. - Female patient is pregnant or breast-feeding. - Patient currently is enrolled in another clinical research study and/or is receiving an investigational agent for any reason. | |
| 81 | NCT00418093 | terminated | the study was terminated early due to a lack of accural | 0 | phase 2 | ['ovarian cancer', 'fallopian tube cancer', 'primary peritoneal cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['C57.00', 'C57.01', 'C57.02']", "['K65.1', 'K66.0', 'N99.4', 'N73.6', 'R88.0', 'Z49.32', 'Z49.02']"] | ['gemcitabine', 'oxaliplatin', 'bevacizumab'] | ['C1=CN(C(=O)N=C1N)C2C(C(C(O2)CO)O)(F)F', 'C1CCC(C(C1)[NH-])[NH-].C(=O)(C(=O)O)O.[Pt+2]'] | Inclusion Criteria: - Recurrent ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic or cytologic confirmation of the original primary tumor is required. - Must have measurable disease which is defined as at least one lesion that can be accurately measured in at least one dimension. Each lesion must be >20mm when measured by conventional techniques. - Must have at least one "target lesion" to be used to assess response. - Platinum-sensitive tumors, defined as a platinum free interval of at least 6 months, and may have had up to two prior treatment regimens. - Eastern Cooperative Oncology Group score of 0 or 1 - Life expectancy of 12 weeks or longer - 18 years of age or older - Adequate bone marrow, renal, neurologic and liver function - Normal blood coagulation parameters Exclusion Criteria: - Chemotherapy within last 3 weeks - Current, recent (within 4 weeks), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study. - Known bleeding disorder or coagulopathy, or history of stroke. - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study entry or the anticipation of need for major surgical procedure during the course of the study. - Minor surgical procedures within 14 days of study entry. - Significant cardiovascular disease, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, a history of deep vein thrombosis, or Grade II or greater, clinically significant peripheral vascular disease within 1 year of study entry. - Urine protein:creatinine ration greater than or equal to 1.0 - History or clinical evidence of central nervous system disease - Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who have evidence of disease within last three years. - More than 2 prior lines of chemotherapy - Previous treatment with a VEGF targeted inhibitor or antibody - Serious non-healing wound, ulcer or bone fracture - Prior radiation therapy to more than one-third of hematopoietic sites. - History of abdominal fistulas, gastrointestinal perforation, intra-abdominal abscess, or partial bowel obstruction within 6 months - Pregnant or lactating |
| 82 | NCT00070291 | terminated | slow accrual. | 0 | phase 2 | ['lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['cyclosporine'] | ['CCC1C(=O)N(CC(=O)N(C(C(=O)NC(C(=O)N(C(C(=O)NC(C(=O)NC(C(=O)N(C(C(=O)N(C(C(=O)N(C(C(=O)N(C(C(=O)N1)C(C(C)CC=CC)O)C)C(C)C)C)CC(C)C)C)CC(C)C)C)C)C)CC(C)C)C)C(C)C)CC(C)C)C)C'] | Inclusion Criteria: - Diagnosis of angioimmunoblastic T-cell lymphoma (recurrent or refractory) based on histologic examination. - At least one objective measurable or evaluable disease parameter. - Have failed at least one type of treatment: chemotherapy, auto-transplant, or steroid treatment. Patients may not receive concurrent chemotherapy. - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. - Adequate renal function as indicated by creatinine <= 1.5 the upper limit of normal (ULN). - Adequate liver function as indicated by alkaline phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) <= 2x the upper limit of normal. - Total bilirubin <= 2x the upper limit of normal. - Age 18 or older. Exclusion Criteria: - Prior cyclosporine or Tacrolimus (FK506). - Prior allogeneic transplant. - Evidence of active infection. - Congestive heart failure, kidney failure, liver failure, or other severe co-morbidities. - Evidence of active neurological impairment. - Previous history of hypersensitivity to cyclosporine and/or Cremorphor EL (polyoxyethylated oil). - History of other malignancies (other than cured carcinomas in situ of the cervix or basal cell carcinoma of the skin). - pregnant or breastfeeding women. - Human immunodeficiency virus (HIV) positive. |
| 83 | NCT00411385 | completed | 1 | phase 3 | ['chronic hepatitis c'] | ["['B18.2', 'B18.0', 'B18.1', 'B18.8', 'B18.9', 'K71.3', 'K71.4']"] | ['albumin interferon alfa-2b', 'peginterferon alfa-2a', 'ribavirin'] | ['C1=NC(=NN1C2C(C(C(O2)CO)O)O)C(=O)N'] | Key Inclusion Criteria: - Diagnosis of chronic hepatitis C. - Liver biopsy performed within 2 years of Day 0 or during screening. - Infected with hepatitis C virus genotype 2/3. - Interferon alfa treatment naïve (ie, have never been treated with an interferon product). - Subjects are eligible to enter the study if they (or their partners) are not pregnant or nursing, are sterile, or of non childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study and for 7 months after the last dose of ribavirin. - Have compensated liver disease. Key Exclusion Criteria: - Decompensated liver disease including those subjects with a past history or presence of ascites, bleeding varices or hepatic encephalopathy. - History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt. - Positive for human immunodeficiency virus (HIV-1) or hepatitis B surface antigen (HBsAG). - Clinical diagnosis of other causes of chronic liver disease including but not limited to hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, hemochromatosis, Wilson's Disease, or alpha 1-antitrypsin deficiency. - A history of immunologically mediated disease (eg, rheumatoid arthritis, inflammatory bowel disease, moderate/severe psoriasis, sarcoidosis, systemic lupus erythematosus). - Active seizure disorder within the last 2 years. - Organ transplant other than cornea and hair transplant. - Clinically significant hemoglobinopathy (eg, thalassemia, sickle cell anemia). - Cancer within the last 5 years(with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix). - Drug or alcohol addiction within the last 6 months. Subjects in a supervised methadone treatment program may be enrolled in the study. - Received any experimental agent within 28 days prior to Day 0. | |
| 84 | NCT01257334 | unknown status | 1 | phase 3 | ['type 2 diabetes'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['bi 10773'] | ['C1COCC1OC2=CC=C(C=C2)CC3=C(C=CC(=C3)C4C(C(C(C(O4)CO)O)O)O)Cl'] | Inclusion Criteria: - Diagnosis of type 2 diabetes mellitus prior to informed consent - Male and female patients on a diet and exercise regimen who are pre-treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses). The treatment regimen has to be unchanged for 12 weeks prior to randomisation. 1. Minimum dose for metformin: - ≥1500 mg/day or - maximum tolerated dose or - maximum dose according to local label 2. Minimum dose for sulfonylurea: - ≥half of the maximal recommended dose or - maximum tolerated dose or - maximum dose according to local label - HbA1c of ≥ 7.0% and ≤ 10% at Visit 1 (screening) in order to be eligible for randomized treatment. HbA1c of > 10% at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773) - Age ≥ 18 - BMI ≤ 45 kg/m2 (BodyMass Index) at Visit 1 (Screening) - Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation Exclusion Criteria: - Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day) - Any other antidiabetic drug within 12 weeks prior to randomisation except those mentioned in inclusion criterion 2 - Acute coronary syndrome including myocardial infarction, stroke or TIA within 3 months prior to informed consent - Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT),or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase - Impaired renal function, defined as eGFR<30 ml/min (severe renal impairment) as determined during screening and/or run-in phase - Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption - Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years - Contraindications to metformin and/or sulfonylurea according to the local label for those patients that enter the study with the respective background therapy - Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g.malaria, babesiosis, haemolytic anaemia) - Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight - Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2D - Pre-menopausal women (last menstruation ≤ 1 year prior to informed consent) who: - are nursing or pregnant or - are of child-bearing potential and are not practicing an acceptable method of birthcontrol, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner - Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake - Participation in another trial with an investigational drug within 30 days prior to informed consent - Any other clinical condition that would jeopardize patients safety while participating in this clinical trial | |
| 85 | NCT00535782 | completed | 1 | phase 3 | ['rheumatoid arthritis'] | ["['M06.9', 'M05.9', 'M06.08', 'M06.00', 'M06.011', 'M06.012', 'M06.019']"] | ['tocilizumab', 'placebo', 'methotrexate'] | ['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: - adult patients, 18-75 years of age - rheumatoid arthritis (RA) of >6 months duration - able to receive outpatient treatment - on methotrexate for at least 12 weeks before entering study, at a stable dose of 7.5-25 mg/week for the last 8 weeks - oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) permitted, if at a stable dose for 4 weeks before study start Exclusion Criteria - major surgery (including joint surgery) within 8 weeks prior to screening, or planned surgery within 6 months after entering study - history of, or current inflammatory joint disease or rheumatic autoimmune disease other than RA - inadequate response to anti-tumor necrosis factor (TNF) agent during the 6 months prior to baseline, or inadequate response to >2 anti-TNF agents - initiation of treatment with lipid lowering agents within 12 weeks prior to baseline | |
| 86 | NCT01230619 | completed | 0 | phase 2 | ['seasonal allergic rhinitis'] | ["['J30.2']"] | ['rv568', 'placebo'] | ['Status: 503'] | Inclusion Criteria: - Subject is healthy - History of seasonal allergic rhinitis - Male aged between 18 and 55 years - Body weight >/= 50 kg with BMI in range 19 - 29 kg/m2 (inclusive) - Exhibits a moderate response to 4 hour exposure to grass pollen in the challenge chamber with a total nasal symptom score (TNSS) of >/= 6 - Positive skin prick test (wheal >/= 4 mm) for grass pollen - Positive total IgE result (RAST class >/= 2) for grass pollen - Current non-smoker who has not used tobacco in the past 6 months with a pack history of </= 10 pack years - Baseline FEV1 >/= 80% and FEV1/FVC >/= 70% of predicted values - No conditions or factors that may preclude subjects ability to remain in the challenge chamber for a period of 6 hours - capable of giving informed consent and is compliant with protocol requirements - available to complete all study measurements Exclusion Criteria: - structural nasal abnormalities or nasal polyps, history of frequent nosebleeds, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection - history of drug allergy - participation in another clinical trial or has participated in a study using an NCE within the previous 3 months, or any clinical study within 1 month - taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins, macrolides, anti-fungal agents and herbal remedies. Paracetamol (</= 2g / day) and occasional short acting beta agonists are permitted - use of oral, injectable or dermal steroids within 5 weeks or intranasal and/or inhaled steroids within 1 week of the screening visit - past or present disease, which as judged by the investigator, may affect the outcome of the study - regular consumption of > 21 units alcohol per week - infected with Hepatitis B, Hepatitis C, or HIV virus - current or chronic history of liver disease, or known hepatic or biliary abnormalities - positive test for drugs of abuse or alcohol at screening - previously known allergy to any of the active or inactive ingredients in the study medication - mentally or legally incapacitated - any other reason that the investigator considers makes the subject unsuitable to participate | |
| 87 | NCT00068666 | terminated | 0 | phase 2 | ['melanoma (skin)', 'metastatic cancer'] | ["['C43.51', 'C43.9', 'C43.52', 'D03.51', 'C43.8', 'Z85.820', 'D03.52']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['temozolomide'] | ['CN1C(=O)N2C=NC(=C2N=N1)C(=O)N'] | DISEASE CHARACTERISTICS: - Histologically confirmed stage IV malignant melanoma with measurable and unresectable disease limited to the central nervous system (CNS) - Study entry within 14 days of diagnosis of brain metastases - Recursive partitioning analysis class I or II - Disease for which no known standard therapy exists that is potentially curative or proven capable of extending life expectancy - No meningeal carcinomatosis based on imaging studies or on positive results from CSF analysis - No evidence of metastatic disease outside of the CNS PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9.0 g/dL Hepatic - AST no greater than 3 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 3 times ULN Renal - Creatinine no greater than 1.5 times ULN Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No concurrent uncontrolled infection - No other malignancy within the past 5 years except basal cell or squamous cell skin cancer treated with local resection only - No prior allergy or intolerance to dacarbazine - No hypersensitivity to temozolomide or any of its components PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior biologic therapy - More than 4 weeks since prior immunotherapy Chemotherapy - No prior temozolomide - More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy - Concurrent steroids allowed if dose stable for at least 7 days prior to CNS imaging Radiotherapy - More than 4 weeks since prior radiotherapy - No prior radiotherapy to more than 15% of the bone marrow - No prior radiotherapy to the head and neck area - No prior radiosurgery | |
| 88 | NCT00551616 | completed | 1 | phase 3 | ['contraception'] | ["['Z92.0', 'Z30.012', 'Z30.09']"] | ['cdb-2914', 'levonorgestrel'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern Ireland (UK) and 18 years or more in Ireland and US - present within 120 hours of unprotected intercourse - regular menstrual cycles - No current use of hormonal contraception - Willing to not use hormonal methods of contraception until study completion - At least one complete menstrual cycle (2 menses) post miscarriage, delivery or abortion - For women who present more than 72 hours after intercourse, decline the insertion of an Intra Uterine Device for emergency contraception - Able to provide informed consent - Willing to abstain from further acts of unprotected intercourse until study completion Exclusion Criteria: - One or more acts of unprotected intercourse more than 120 hours - current or recent use of hormonal methods of contraception - currently pregnant or breastfeeding - tubal ligation or current use of IUD - Use of hormonal emergency contraception since last menstrual period - Current use of IUD - Tubal ligation - Partner with a vasectomy - Unsure about the date of the last menstrual period - Severe asthma insufficiently controlled by oral glucocorticoid - Hypersensitivity to the active substance levonorgestrel or any of the excipients of the drug products used in the study | |
| 89 | NCT00591578 | completed | 1 | phase 3 | ['hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['azilsartan medoxomil', 'azilsartan medoxomil', 'valsartan'] | ['CCOC1=NC2=CC=CC(=C2N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NOC(=O)N5)C(=O)OCC6=C(OC(=O)O6)C', 'CCOC1=NC2=CC=CC(=C2N1CC3=CC=C(C=C3)C4=CC=CC=C4C5=NOC(=O)N5)C(=O)OCC6=C(OC(=O)O6)C', 'CCCCC(=O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NNN=N3)C(C(C)C)C(=O)O'] | Inclusion Criteria 1. Essential hypertension (defined as sitting trough clinic systolic blood pressure between 150 and 180 mm Hg inclusive at Day minus 1 and 24-hour mean systolic blood pressure between 130 and 170 mm Hg inclusive at Day 1). 2. 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. 3. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator. 4. Willing to discontinue current antihypertensive medications at the Screening Day minus 21 visit. If the subject is on amlodipine prior to Screening, the subject is willing to discontinue this medication at Screening Day minus 28. Exclusion Criteria 1. Sitting trough clinic diastolic blood pressure greater than 114 mm Hg at Day minus 1. 2. The subject has a baseline 24-hour ambulatory blood pressure monitor reading of insufficient quality. 3. 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. 4. Hypersensitive to angiotensin II receptor blockers. 5. Recent history (within the last 6 months) of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack. 6. Clinically significant cardiac conduction defects (eg, 3rd degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation or flutter). 7. Hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease. 8. Secondary hypertension of any etiology. 9. Non-compliant (less than 70% or greater than 130%) with study medication during placebo run-in period. 10. Severe renal dysfunction or disease (based on calculated creatinine clearance less than 30 mL per min/1.73m2) at Screening. 11. Known or suspected unilateral or bilateral renal artery stenosis. 12. History of drug or alcohol abuse within the past 2 years. 13. Previous history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. (This criterion does not apply to those subjects with basal cell or Stage 1 squamous cell carcinoma of the skin). 14. Type 1 or poorly controlled type 2 diabetes mellitus (glycosylated hemoglobin greater than 8.0%) at Screening. 15. Hyperkalemia as defined by the central laboratory normal reference range at Screening. 16. Upper arm circumference less than 24 cm or greater than 42 cm. 17. Works night (3rd) shift (defined as 11PM to 7AM). 18. Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice at Screening. 19. Currently is participating in another investigational study or has participated in an investigational study within 30 days prior to randomization. 20. Any other serious disease or condition at Screening (or Randomization) that would compromise subject safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol. 21. Randomized in a previous azilsartan medoxomil study. | |
| 90 | NCT00428714 | completed | 0 | phase 2 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['enzastaurin'] | ['CN1C=C(C2=CC=CC=C21)C3=C(C(=O)NC3=O)C4=CN(C5=CC=CC=C54)C6CCN(CC6)CC7=CC=CC=N7'] | Inclusion Criteria: - You are expected to be alive in the 12 weeks. - You are at least 18 years old. - You live close enough to the doctor's office to attend all of your required visits. - You have not been treated with chemotherapy for your prostate cancer (cohort 1). - Must have evidence of androgen-independent PSA-progressive disease without a history of or current (as judged by the investigator) clinical or radiographic evidence of metastatic disease with castrate levels of testosterone (<50 ng/dL) maintained by luteinizing hormone-releasing hormone (LHRH) agonist or bilateral orchiectomy following standard anti-androgen withdrawal. NOTE: PSA progression is defined as have rising PSA values of <=5 ng/mL (at least 3 measurements 1 week apart) with castrate levels of testosterone <50 ng/dL following appropriate antiandrogen withdrawal, without evidence of metastases. (cohort 1) - No prior systemic chemotherapy for prostate cancer. No prior chemotherapy for any other indication within 2 years of study entry. NOTE: Participants previously treated with chemotherapy in the adjuvant/neoadjuvant setting were not be eligible. (cohort 1) - You have had one prior docetaxel-based chemotherapy regimen (cohort 2). - You have evidence of metastatic prostate cancer with bone or soft tissue disease (cohort 2). - Must have evidence of docetaxel-resistant, androgen-independent metastatic prostate cancer with bone or soft tissue disease (PSA only participants are not eligible) defined as either: clinical, PSA or radiographic disease progression while receiving docetaxel-based therapy or PSA and/or radiographic progression at any time after completion of a docetaxel-containing regimen with PSA progression defined as a 25% increase in PSA from the post docetaxel value or interval progression in known metastatic sites of disease or development of new sites of disease on bone scan or computed tomography (CT) imaging. Note: Participants who discontinued a docetaxel-containing regimen due to toxicity or any other reasons not related to disease progression while on treatment, and were not able to complete at least 2 cycles, were not be eligible. (cohort 2) - Your organs must be functioning properly. Exclusion Criteria: - You are unable to swallow pills. - You have another illness besides your prostate cancer. - You have taken another experimental drug within the last 30 days. - You have a serious heart condition. - You are receiving another anti-cancer therapy. | |
| 91 | NCT01644474 | completed | 1 | phase 3 | ['hypercholesterolemia'] | ["['E78.01', 'E78.00', 'Z83.42']"] | ['alirocumab', 'ezetimibe', 'placebo (for alirocumab)', 'placebo (for ezetimibe)'] | ['Status: 503', 'Status: 503', 'Status: 503', 'Status: 503'] | Inclusion criteria: - Participants with hypercholesterolemia Exclusion criteria: - Age < 18 or legal age of adulthood, whichever was greater - LDL-C < 100 mg/dL (< 2.59 mmol/L) or > 190 mg/dL (> 4.9 mmol/L) - Fasting serum triglycerides (TG) > 400 mg/dL (> 4.52 mmol/L) - Known history of homozygous or heterozygous familial hypercholesterolemia The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. | |
| 92 | NCT01436110 | completed | 1 | phase 3 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['fluticasone furoate 50mcg', 'fluticasone propionate 100mcg', 'placebo'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - Signed informed consent - Outpatient at least 12 years of age with a diagnosis of asthma at least 12 weeks prior to first visit - Both genders; females of child bearing potential must be willing to use appropriate contraception during the study - Pre-bronchodilator FEV1 of at least 60% predicted - FEV1 reversibility of at least 12% and 200ml - Current asthma therapy that includes a non-corticosteroid controller and/or short acting beta-agonist Exclusion Criteria: - History of life-threatening asthma exacerbation with the past 10 years - Asthma exacerbation requiring oral corticosteroids within the past 3 months or overnight hospital stay within the past 6 months - Current or recent respiratory infection or current oral candida infection - Presence of a significant respiratory disease or other medical condition that is uncontrolled or that could affect subject safety or study outcome - Known or suspected allergy to study medication or materials - Taking another investigational medication or prohibited medication during the study - Current smokers or former smokers with significant tobacco exposure - Previous treatment with fluticasone furoate in a phase II or III study - Children in Care | |
| 93 | NCT00096486 | completed | 0 | phase 1/phase 2 | ['lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['everolimus', 'gefitinib'] | ['CC1CCC2CC(C(=CC=CC=CC(CC(C(=O)C(C(C(=CC(C(=O)CC(OC(=O)C3CCCCN3C(=O)C(=O)C1(O2)O)C(C)CC4CCC(C(C4)OC)OCCO)C)C)O)OC)C)C)C)OC', 'COC1=C(C=C2C(=C1)N=CN=C2NC3=CC(=C(C=C3)F)Cl)OCCCN4CCOCC4'] | DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following stage criteria: - Stage IIIB (unresectable, with malignant pleural or pericardial effusion) - Stage IV disease - Recurrent disease - Measurable or evaluable indicator lesions - Progressive disease after receiving ≥ 1 prior chemotherapy regimen that included cisplatin or carboplatin and docetaxel - No uncontrolled brain or leptomeningeal metastases - Must not require concurrent glucocorticoids for control of metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% OR - ECOG 0-2 Life expectancy - Not specified Hematopoietic - WBC ≥ 3,000/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9.0 g/dL Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST ≤ 2.5 times ULN Renal - Creatinine ≤ 1.5 times ULN OR - Creatinine clearance ≥ 60 mL/min Cardiovascular - No congestive heart failure - No New York Heart Association class III or IV heart disease - No unstable angina Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No severe infection - No severe malnutrition - No other serious medical illness - No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent biologic therapy - No concurrent immunotherapy Chemotherapy - See Disease Characteristics - No prior conventional chemotherapy for metastatic or recurrent NSCLC (phase II only) - At least 4 weeks since prior chemotherapy - No other concurrent chemotherapy Endocrine therapy - See Disease Characteristics - No concurrent oral steroids for management of skin toxicity Radiotherapy - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - At least 4 weeks since prior major surgery - No concurrent surgery for an identifiable lesion Other - Recovered from all prior therapy - No prior gefitinib, erlotinib, or other epidermal growth factor tyrosine kinase inhibitor - No concurrent cytotoxic therapy (e.g., methotrexate for rheumatoid arthritis) - No other concurrent oncolytic agents | |
| 94 | NCT00003625 | completed | 0 | phase 1 | ['brain tumors', 'central nervous system tumors'] | ["['C71.7', 'C71.9', 'C79.31', 'D33.0', 'D33.1', 'D33.2', 'D49.6']", "['C72.9', 'D33.9', 'D43.9', 'D33.7', 'D43.8']"] | ['cyclosporine', 'etoposide', 'vincristine sulfate'] | ['Status: 503', 'Status: 503', 'Status: 503'] | DISEASE CHARACTERISTICS: Newly diagnosed diffuse intrinsic brain stem glioma by MRI Biopsy is neither necessary nor encouraged A least two-thirds of the tumor is in the pons Origin of the tumor is clearly in the pons Must be registered within 28 days of diagnosis Clinical history less than 6 months duration (cranial nerve deficit, long tract signs, or ataxia) No diffuse leptomeningeal disease PATIENT CHARACTERISTICS: Age: 3 to 21 Performance status: Karnofsky or Lansky 50-100% Life expectancy: At least 6 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 75,000/mm3 Hepatic: SGPT less than 2 times normal Renal: Creatinine normal for age OR Creatinine clearance greater than 70 mL/min PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Prior steroids at stable or decreasing doses allowed Radiotherapy: No prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents | |
| 95 | NCT00036842 | completed | 0 | phase 2 | ['extragonadal germ cell tumor', 'testicular germ cell tumor'] | ["['E29.0', 'E29.1', 'E29.8', 'E29.9', 'E89.5', 'N50.811', 'N50.812']"] | ['arsenic trioxide'] | ['[O-2].[O-2].[O-2].[As+3].[As+3]'] | DISEASE CHARACTERISTICS: - Histologically confirmed testicular or extragonadal germ cell cancer - Refractory disease, defined by at least 1 of the following criteria: - Disease progression during or within 4 weeks of cisplatin-containing regimen - Progression is defined as the appearance of new or progression of known locally advanced or metastatic disease or a rise in tumor markers (beta-human chorionic gonadotropin (beta-HCG) or alpha fetoprotein (AFP)) by at least 50% relative to the nadir - When the only evidence of germ cell progression or recurrence before study entry is the appearance of a new lesion in the absence of tumor marker elevation, a biopsy is required to confirm the diagnosis - Disease recurrence after at least 2 chemotherapy regimens, one of which includes high-dose therapy (chemotherapy with stem cell support) - Disease recurrence after at least 2 chemotherapy regimens and not eligible for high-dose therapy - At least 1 of the following: - Unidimensionally measurable disease - Soft tissue, irradiated within the past 2 months, is not considered measurable - Elevated beta-HCG (more than 20 mIU/mL) - AFP greater than 2 times upper limit of normal PATIENT CHARACTERISTICS: Age: - 16 and over Sex: - Male Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - WBC at least 3,000/mm^3 Hepatic: - Bilirubin less than 2.5 times upper limit of normal (ULN) - SGOT less than 5 times ULN - Alkaline phosphatase less than 5 times ULN Renal: - Creatinine no greater than 2.5 times ULN OR - Creatinine clearance at least 40 mL/min - Potassium normal - Magnesium normal - No renal dialysis Cardiovascular: - No prior torsades de pointes-type ventricular arrhythmia - No prolonged QT interval (greater than 450 msec) on ECG in presence of normal potassium and magnesium Other: - Fertile patients must use effective contraception - No active serious infection not controlled by antibiotics - No known hypersensitivity to arsenic - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II disease in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics - More than 28 days since prior cytotoxic agents Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 28 days since prior radiotherapy and recovered Surgery: - Not specified Other: - More than 28 days since prior experimental agents - No concurrent or planned drugs known to prolong the QT interval | |
| 96 | NCT01387204 | completed | 0 | phase 1 | ['cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['gsk1120212'] | ['CC1=C2C(=C(N(C1=O)C)NC3=C(C=C(C=C3)I)F)C(=O)N(C(=O)N2C4=CC=CC(=C4)NC(=O)C)C5CC5'] | Inclusion Criteria: 1. Male 18 years old or older. 2. Written informed consent provided 3. Body weight greater than or equal to 45 kg and a BMI greater than or equal to 19 kg/m2 and less than or equal to 35 kg/m2 (inclusive). 4. Able to swallow and retain oral medication. 5. Histologically or cytologically confirmed diagnosis of a solid tumor. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 7. Agree to use one of the contraception methods listed in the protocol from the time of the first dose of study medication until sixteen weeks after the last dose of study medication. 8. A history of regular bowel movements (approximately once per day). 9. Adequate baseline organ function as listed in the protocol. Exclusion Criteria: 1. Currently receiving cancer therapy as specified in the protocol. 2. Serious and/or unstable pre-existing medical psychiatric disorder, or other conditions. 3. Any major surgery within the last four weeks. 4. Unresolved toxicity equal to or greater than Grade 2 from previous anti-cancer therapy except alopecia. 5. An occupation within the past 12 months which requires monitoring for radiation exposure, nuclear medicine procedures or excessive x-rays. 6. Radiation exposure from the previous three year period over 10 mSv if exposed to ionizing radiation above background as a result of work with radiation as category A (classified) workers or as a result of research studies. 7. History of interstitial lung disease or pneumonitis. 8. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to dimethyl sulfoxide (DMSO). 9. Current use of a prohibited medications described in the protocol. • Use of anticoagulants such as warfarin is permitted. 10. History RVO or CSR. - Predisposing factors to RVO or CSR. - Visible retinal pathology that is considered a risk factor for RVO or CSR such as: - Evidence of new optic disc cupping - Intraocular pressure greater than 21 mm Hg as measured by tonography. 11.1. Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. (Previously treated and have had stable CNS disease for greater than 3 months, asymptomatic and off corticosteroids, or on stable dose of corticosteroids for at least 1 month prior to study Day 1 are permitted). 11.2. Receiving enzyme inducing anti-epileptic drugs (EIAEDs). 12. History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within the past 6 months. 13. QTcB greater than or equal to 480 msec. 14. History or evidence of current clinically significant uncontrolled arrhythmias. 15. History or evidence of current greater than or equal to Class II congestive heart failure. 16. Active gastrointestinal disease or other condition (e.g., gastrectomy, bariatric surgery, small bowel or large bowel resection, or cholecystectomy). 17. A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus, or Hepatitis C Virus. 18. Alcohol or drug abuse within six months prior to screening. 19. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drugs or excipients. 20. Participated in a clinical trial and has received an investigational product within 30 days or five half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) before the 1st dose. 21. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. 22. Mentally or legally incapacitated. | |
| 97 | NCT01327703 | completed | 1 | phase 4 | ['exocrine pancreatic insufficiency', 'cystic fibrosis'] | ["['K86.81']", "['E84.9', 'Z14.1', 'E84.0', 'E84.11', 'E84.8', 'E84.19', 'P09.4']"] | ['panzytrat® 25,000', 'kreon® 25,000'] | ['Status: 503', 'Status: 503'] | Inclusion Criteria: - Participant or his/her legal representative signed informed consent form (ICF) prior to starting any study procedures - Participant with clinical diagnosis of CF based on one or more typical clinical features of CF phenotype, in addition to one of the following: a genotype that documents the presence of 2 CF-causing mutation, or a sweat chloride test greater than or equal to 60 millimole per liter (mmol/L) by quantitative pilocarpine iontophoresis on two separate occasions - Participant with severe EPI confirmed by enzyme-linked immunosorbent assay (ELISA) measurement of fecal elastase-1 (FE-1) - Male or female participant aged 7 years or older - Participant currently receiving and has received a stable dose of lipase with either Panzytrat® 25,000 or Kreon® 25,000 for at least 30 days prior to ICF signature - Participant generally in good health, except for the underlying symptoms associated with CF and EPI, and is clinically stable (no change in the last 30 days of physical examination) as evidenced by medical and medication histories, physical examination including vital signs during screening and laboratory tests - Participant able to maintain a CF standardized diet with a lipid content customized to his/her needs during the study according to the qualification phase diary - Women of childbearing potential must have a negative pregnancy test at study entry and must use a medically acceptable contraceptive method for the duration of the study Exclusion Criteria: - Participant with known contraindication, sensitivity or hypersensitivity to Panzytrat® 25,000 or Kreon® 25,000, or to any porcine protein - Participant who recently received treatment of an emergent acute infection with oral or intravenous (IV) antibiotics that was not stopped at least 14 days prior to randomization - Participant with chronic use of narcotics that were not stopped at least 7 days prior to the qualification visit - Participant using of any prohibited medications or products listed in the prohibited medication section of the protocol - Participant with acute pancreatitis or exacerbation of chronic pancreatic disease - Participant with history of significant bowel resection that could impair fat absorption - Participant with any condition known to increase fecal fat loss including but not limited to: celiac disease, Crohn's disease, tropical sprue, bacterial bowel infection, liver disease, lactose intolerance, pseudomembranous colitis, biliary and pancreatic cancer, radiation enteritis, Whipple's disease, Whipple's procedure, etc - Participant with any significant gastrointestinal dysmotility disorders - Participant with chronic abdominal pain or severe abdominal pain at study entry - Participant using enteral tube feeding over day and night - Participant with history or presence of clinically significant portal hypertension - Participant with history or presence of complete distal intestinal obstruction syndrome (DIOS) in the past 6 months, or 2 or more episodes of DIOS in the past year - Participant with poorly controlled diabetes as per the investigator's opinion - Female participants who are pregnant or breastfeeding - Participant with any condition or history of any illness, or pre-study laboratory abnormality which, in the opinion of the investigator or sponsor, might put the participant at risk, prevent the participant from completing the study, or otherwise affect the outcome of the study - Participant using any investigational drug within 30 days prior to the date of signature of the ICF | |
| 98 | NCT00436839 | completed | 1 | phase 3 | ['prostatic neoplasms'] | ["['B38.81', 'N42.31', 'Z87.430', 'N40.0', 'N40.1']"] | ['docetaxel', 'mitoxantrone', 'prednisone'] | ['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', 'C1=CC(=C2C(=C1NCCNCCO)C(=O)C3=C(C=CC(=C3C2=O)O)O)NCCNCCO', 'CC12CC(=O)C3C(C1CCC2(C(=O)CO)O)CCC4=CC(=O)C=CC34C'] | Inclusion Criteria: - Histologically or cytologically proven prostate adenocarcinoma - Androgen independent prostate Cancer S/P orchiectomy and/or LHRH agonist Testosterone < 50 ng/dl (ie 1.735 nmol/l) - Documented progressive disease - Patients should have achieved stable analgesia for 7 days - Karnofsky Performance Status ≥ 70 - No prior treatment with cytotoxic agent (except estramustine) - Normal cardiac function must be confirmed by Left ventricular ejection fraction - Adequate organ function: 1. Hematology: - Neutrophils > 1.5 x 10^9/L - Hemoglobin > 10 g/dl. Erythropoietin use is allowed, but red blood cell transfusion to upgrade the hemoglobin level is not allowed - Platelets > 100 x 10^9/L 2. Hepatic function: - Total bilirubin < the upper-normal limit of the institution. - Alanine aminotransferase and Aspartate transaminase < 1.5 times the upper-normal limit of the institution. 3. Renal function: - Creatinine < 1.5 times the upper normal limit (ie National Cancer Institution grade < 1) - No brain or leptomeningeal metastases Exclusion Criteria: - Prior radiotherapy to >25% of bone marrow (whole pelvic irradiation is not allowed) - prior cytotoxic chemotherapy, except monotherapy with estramustine - prior isotope therapy - history of another cancer within the preceding five year - symptomatic peripheral neuropathy grade ≥ 2 - other serious illness or medical condition: 1. Congestive heart failure even if controlled. Previous history of myocardial infarction or angina pectoris within 1 year from study entry, uncontrolled hypertension or uncontrolled arrhythmias. 2. Active uncontrolled infection 3. Peptic ulcer, unstable diabetes mellitus or other contraindications for the use of corticosteroids. 4. Auto-immune disease (lupus, sclerodermia, rheumatoid polyarthritis) - treatment with any other anti-cancer therapy - treatment with bisphosphonates The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. | |
| 99 | NCT00672646 | completed | 0 | phase 2 | ['pain'] | ["['N50.82', 'R07.2', 'R07.82', 'R10.13', 'R10.33', 'R14.1', 'R52']"] | ['azd1386', 'naproxen', 'placebo'] | ['CC1=CC(=CC2=C1N(C(=O)C23C(=O)NC(=O)N3)CC4=CC(=CC=C4)C(F)(F)F)Cl', 'CC(C1=CC2=C(C=C1)C=C(C=C2)OC)C(=O)O'] | Inclusion Criteria: - Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar. - Provision of signed informed consent. Exclusion Criteria: - History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator. - Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator. - A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives - Patients with a body temperature >37.5°C at Visit 2, before start of surgical procedures | |
| 100 | NCT00515086 | terminated | early termination due to slow enrollment and protocol-defined stopping rule. | 0 | phase 2 | ['glioblastoma multiforme'] | ["['L51.0', 'L51.8', 'L51.9']"] | ['everolimus'] | ['Status: 503'] | Inclusion Criteria: - Age 18 years of age or older - Histologically confirmed Glioblastoma Multiforme (GBM) - Radiographic evidence of disease progression - Patients must have evaluable contrast enhancing tumor - Availability of paraffin blocks or unstained pathology slides for biomarker studies - Karnofsky Performance Status of greater than or equal to 60% Exclusion Criteria: - Prior treatment with Mammalian target of rapamycin (mTOR) inhibitor - History of another malignancy within 3 years - Cardiac pacemaker - Ferromagnetic metal implants other than those approves as safe for use in Magnetic resonance imaging (MRI) scanners - Claustrophobia - Obesity - Unstable systemic diseases - Elevated cholesterol or triglycerides - Radiation therapy or cytotoxic chemotherapy <=4 weeks prior to study enrollment. Patient must have recovered from the toxic effects of a prior chemotherapy. - Patients must be off all enzyme inducing anticonvulsants for at least 2 week before study enrollment can occur - Need for increasing dose of steroids. Patients on a stable or tapering dose of steroids >=7 days were permitted. |