Downloads: 1
| # | nctid | status | why_stop | label | phase | diseases | icdcodes | drugs | smiless | criteria |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00174785 | completed | 1 | phase 3 | ['atrial fibrillation', 'atrial flutter'] | ["['I48.0', 'I48.21', 'I48.91', 'I48.11', 'I48.19', 'I48.20']", "['I48.3', 'I48.4', 'I48.92']"] | ['dronedarone (sr33589)', 'placebo'] | ['CCCCN(CCCC)CCCOC1=CC=C(C=C1)C(=O)C1=C(CCCC)OC2=C1C=C(NS(C)(=O)=O)C=C2', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - 1. Patients aged 75 years or older (70 years before protocol amendment 1), or patients aged at least 70 years (any age before protocol amendment 1) with one or more of the following risk factors at baseline: - Hypertension (taking antihypertensive drugs of at least two different classes) - Diabetes - Prior cerebrovascular accident (stroke or transient ischemic attack) or systemic embolism - Left atrium diameter greater than or equal to 50 mm by echocardiography - Left ventricular ejection fraction less than 0.40 by 2D-echocardiography (two-dimensional echocardiography) - 2. Availability of one electrocardiogram (ECG) within the last 6 months, showing that the patient was or is in AF/AFL - 3. Availability of one ECG within the last 6 months, showing that the patient was or is in sinus rhythm Exclusion Criteria: General criteria: - 1. Refusal or inability to give informed consent to participate in the study - 2. Any non cardiovascular illness or disorder that could preclude participation or severely limit survival including cancer with metastasis and organ transplantation requiring immune suppression - 3. Pregnant women (pregnancy test must be negative) or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intra-uterine device (IUD)] or sterile can be randomized. - 4. Breastfeeding women - 5. Previous (2 preceding months) or current participation in another clinical trial with an investigational drug (under development) or with an investigational device - 6. Previous participation in this trial Criteria Related to a cardiac condition: - 7. Patients in permanent atrial fibrillation - 8. Patients in unstable hemodynamic condition such as acute pulmonary edema within 12 hours prior to start of study medication; cardiogenic shock; treatment with intra-venous pressor agents; patients on respirator; congestive heart failure of stage NYHA IV (New York Heart Association classification) within the last 4 weeks; uncorrected, hemodynamically significant primary obstructive valvular disease; hemodynamically significant obstructive cardiomyopathy; a cardiac operation or revascularization procedure within 4 weeks preceding randomization - 9. Planned major non-cardiac or cardiac surgery or procedures including surgery for valvular heart disease, coronary artery bypass graft (CABG) , percutaneous coronary intervention (PCI) , or on urgent cardiac transplantation list - 10. Acute myocarditis or constrictive pericarditis - 11. Bradycardia < 50 bpm and/or PR-interval > 0.28 sec on the last 12-lead ECG - 12. Significant sinus node disease (documented pause of 3 seconds or more) or 2nd or 3rd degree atrioventricular block (AV-block) unless treated with a pacemaker Criteria Related to Concomitant Medications: - 13. Need of a concomitant medication that is prohibited in this trial, including the requirement for Vaughan Williams Class I and III anti-arrhythmic drugs, that would preclude the use of study drug during the planned study period Criteria Related to Laboratory Abnormalities: - 14. Plasma potassium < 3.5 mmol/l (as anti-arrhythmic drugs can be arrhythmogenic in patients with hypokalemia, this must be corrected prior to randomization) - 15. A calculated Glomerular Filtration Rate (GFR) at baseline <10 ml/min using the Cockroft Gault formula | |
| 2 | NCT00086346 | terminated | 0 | phase 3 | ['liver transplantation'] | ["['Z52.6', 'K71.8', 'K71.7', 'A06.4', 'C22.0', 'C22.3', 'K70.0']"] | ['sirolimus (rapamune)', 'cyclosporine or tacrolimus'] | ['[H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](O)[C@@H](C1)OC', 'CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\\C=C\\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C'] | Inclusion Criteria: - Age greater than 13 years (age greater than 18 years as required by some local regulations). - Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/- corticosteroids +/- antimetabolite. - 6 to 144 months after orthotopic liver transplantation. - Cockcroft-Gault GFR values ≥40 mL/min and ≤90mL/min at screening Exclusion Criteria: - History of nonhepatic transplantation - Evidence of systemic infection (sepsis, bacteremia, pneumonia etc). - Known or suspected malignancy < 5 years before random assignment. | |
| 3 | NCT00428389 | completed | 0 | phase 3 | ["alzheimer's disease"] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['rivastigmine 5 cm^2 transdermal patch', 'rivastigmine 10 cm^2 transdermal patch'] | ['CCN(C)C(=O)OC1=CC=CC(=C1)[C@H](C)N(C)C', 'CCN(C)C(=O)OC1=CC=CC(=C1)[C@H](C)N(C)C'] | Inclusion Criteria: - Be at least 50 years of age; - Have a diagnosis of probable Alzheimer's Disease; - Have an MMSE score of > or = 10 and < or = 24; - Must have a caregiver who is able to attend all study visits; - Have received continuous treatment with donepezil for at least 6 months prior to screening, and received a stable dose of 5 mg/day or 10 mg/day for at least the last 3 of these 6 months. Exclusion Criteria: - Have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk; - Have a history of malignancy of any organ system, treated or untreated, within the past 5 years; - Have a history within the past year or current diagnosis of cerebrovascular disease; - Have a current diagnosis of severe or unstable cardiovascular disease; Have a history of myocardial infarction (MI) in the last six months; - Severe or unstable respiratory conditions (e.g., severe asthma , severe pulmonary (lung) disease); - Digestive problems related to peptic ulcer; - Urinary obstruction or current severe urinary tract infection; - Abnormal thyroid function tests; - Low folate or Vitamin B12; - Have a disability that may prevent the patient from completing all study requirements; - Have a current diagnosis of an active skin lesion/disorder that would prevent adhesion of a patch; Other protocol-defined inclusion/exclusion criteria may apply | |
| 4 | NCT00280566 | completed | 1 | phase 3 | ['bipolar mania', 'bipolar disorder'] | ["['F31.81', 'F31.89', 'F31.9', 'F25.0', 'F31.0', 'F31.31', 'F31.32']"] | ['placebo', 'ziprasidone oral capsule'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'ClC1=C(CCN2CCN(CC2)C2=NSC3=CC=CC=C23)C=C2CC(=O)NC2=C1'] | Inclusion Criteria: Adults meeting DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for Bipolar I Disorder (currently with manic or mixed symptoms) Exclusion Criteria: Ultra rapid cyclers and subjects with significant cardiovascular disease including history of QT prolongation and/or congenital long QT syndrome | |
| 5 | NCT00696631 | terminated | terminated as the active treatment was associated with an increased hazard | 0 | phase 3 | ['congestive heart failure'] | ["['I50.20', 'I50.21', 'I50.22', 'I50.30', 'I50.31', 'I50.32', 'I50.40']"] | ['dronedarone (sr33589)', 'placebo'] | ['CCCCN(CCCC)CCCOC1=CC=C(C=C1)C(=O)C1=C(CCCC)OC2=C1C=C(NS(C)(=O)=O)C=C2', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Patients hospitalized with symptomatic CHF, current New York Heart Association (NYHA) class II-IV requiring treatment with a diuretic, who had had within the last month at least 1 episode of dyspnea or fatigue at rest, or on slight exertion corresponding to NYHA class III or IV - Wall motion index (WMI) ≤1.2 determined by a blinded central evaluation of a recorded standard echocardiography, equivalent to a left ventricular ejection fraction (LVEF) ≤35%. Exclusion Criteria: - acute pulmonary edema within 12 hours prior to start of study medication - various heart conditions (cardiogenic shock, obstructive valvular disease, obstructive cardiomyopathy; acute myocardial infarction, cardiac surgery, acute myocarditis or constrictive pericarditis, history of torsades de pointes, bradycardia <50 bpm and/or PR-interval ≥280 ms, QTc-interval >500 ms, significant sinus node disease) - any illness or disorder other than CHF (cancer with metastasis, organ transplantation) - current participation in another clinical study or currently taking an investigational drug including dronedarone or concomitant prohibited medication or treatment with other class I or III anti-arrhythmic drugs - pregnant and/or breastfeeding women or women of child-bearing potential without adequate birth control - serum potassium <3.5 mmol/L. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
| 6 | NCT00317642 | completed | 0 | phase 3 | ['acute myelogenous leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['clofarabine (iv formulation)', 'placebo', 'cytarabine'] | ['[H][C@]1(F)[C@H](O)[C@@H](CO)O[C@H]1N1C=NC2=C(N)N=C(Cl)N=C12', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'ClCCN(CCCl)P1(=O)NCCCO1'] | Inclusion Criteria: - Have a diagnosis of Acute Myelogenous Leukemia (AML) according to World Health Organization (WHO) classification - Relapsed after receiving up to 2 prior induction regimens (i.e. first or second relapse)or are refractory to not more than one prior combination chemotherapy induction regimen - Be ≥ 55 years of age - Have an Eastern Cooperative Oncology Group (ECOG) score of 0-2 - Be able to comply with study procedures and follow-up examinations - Be nonfertile or agree to use birth control during the study through the end of treatment visit and for at least 90 days after the last dose of study drug - Have adequate liver and renal function as indicated by certain laboratory values Exclusion Criteria: - Received previous treatment with clofarabine - Received bolus, intermediate or high-dose cytarabine as induction therapy unless certain remission criteria are met - Have received a hematopoietic stem cell transplant (HSCT) within the previous 3 months - Have moderate or severe graft versus host disease (GVHD), whether acute or chronic - Are receiving any other chemotherapy or investigational therapy. Patients must have been off prior AML therapy for at least 2-6 weeks prior to entering study. - Have a psychiatric disorder that would interfere with consent, study participation, or follow-up - Have an active, uncontrolled infection - Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system - Have been diagnosed with another malignancy, unless disease-free for at least 5 years; patients with treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed. - Have clinical evidence suggestive of central nervous system (CNS) involvement with leukemia unless lumbar puncture confirms absence of leukemic blasts in the cerebrospinal fluid(CSF) - Known HIV positivity - Are pregnant or lactating | |
| 7 | NCT00133224 | terminated | accrual and treatment with cg1940/cg8711 stopped due to idmc recommendation. | 0 | phase 3 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['chemotherapy (docetaxel and prednisone)'] | ['[H][C@@]12C[C@H](O)[C@@]3(C)C(=O)[C@H](O)C4=C(C)[C@H](C[C@@](O)([C@@H](OC(=O)C5=CC=CC=C5)[C@]3([H])[C@@]1(CO2)OC(C)=O)C4(C)C)OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C1=CC=CC=C1'] | Inclusion Criteria: - Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate - Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy - Detectable metastases - ECOG performance status ≤2 (Performance status of 3 if due to bone pain) - Any Gleason score - Only one prior treatment with systemic chemotherapy - No prior treatment with gene therapy - No prior immunotherapy for prostate cancer - Taxane naïve - Experiencing cancer-related pain |
| 8 | NCT01169779 | completed | 1 | phase 3 | ['type 2 diabetes mellitus'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['lixisenatide (ave0010)', 'placebo', 'metformin', 'sulfonylurea'] | ['[V].[H][C@](C)(O)[C@]([H])(N=C(O)CN=C(O)[C@]([H])(CCC(O)=O)N=C(O)CN=C(O)[C@@]([H])(N)CC1=CN=CN1)C(O)=N[C@@]([H])(CC1=CC=CC=C1)C(O)=N[C@]([H])(C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CC(O)=O)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCC(O)=N)C(O)=N[C@@]([H])(CCSC)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(C)C(O)=N[C@@]([H])(C(C)C)C(O)=N[C@@]([H])(CCCNC(N)=N)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CC1=CC=CC=C1)C(O)=N[C@]([H])(C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CC1=CNC2=CC=CC=C12)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CC(O)=N)C(O)=NCC(O)=NCC(=O)N1CCC[C@@]1([H])C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CO)C(O)=NCC(O)=N[C@@]([H])(C)C(=O)N1CCC[C@@]1([H])C(=O)N1CCC[C@@]1([H])C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N)[C@@]([H])(C)CC)[C@@]([H])(C)O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CSCC[C@H](N)C(O)=O', '[H][C@]1(C)CC[C@@]([H])(CC1)N=C(O)NS(=O)(=O)C1=CC=C(CCN=C(O)N2CC(C)=C(CC)C2=O)C=C1'] | Inclusion criteria: - Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with metformin alone or metformin with sulfonylurea at the time of the screening visit Exclusion criteria: - HbA1c <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 metformin not at a stable dose of at least 1.0 gram per day or more than 1.5 gram per day for at least 3 months prior to screening visit - In case of treatment with sulfonylurea, if the sulfonylurea dosage is less than the maximum effective dose (that is, half of the maximum recommended dose according to local labeling), or is not at a stable (unchanged) dose for at least 3 months prior to screening - FPG at screening >250 milligram per deciliter (mg/dL) (>13.9 millimole per liter [mmol/L]) - History of hypoglycemia unawareness - Body mass index <=20 kilogram per square meter (kg/m^2) - Weight change of >5 kg during the 3 months preceding the screening visit - History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, or inflammatory bowel disease or patients considered by the investigator at high risk for acute pancreatitis (for example, with known history of biliary gallstone[s], or with very high triglyceride level [>=5.65 mmol/L]) at the time of screening - Personal or family history of medullary thyroid cancer or genetic conditions that predispose to medullary thyroid cancer (for example, multiple endocrine neoplasia syndromes); - 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 (SBP) or diastolic blood pressure (DBP) >180 millimeter of mercury (mmHg) or >95 mmHg, respectively - Laboratory findings at the time of screening: amylase and/or lipase: >3 times upper limit of normal (ULN); hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3) and/or platelets <100 000/mm^3; calcitonin >20 picogram per milliliter (5.9 picomole per liter) ; and positive test for Hepatitis B surface antigen and/or Hepatitis C antibody - 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 oral or injectable antidiabetic or hypoglycemic agents other than metformin and sulfonylurea (for example, alpha-glucosidase inhibitor, thiazolidinedione, glucagon-like peptide -1 [GLP-1], receptor agonist, 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 screening; - Participation in a previous study with lixisenatide - Renal impairment defined with creatinine >1.4 mg/dL in women and 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, unstable (that is, worsening) and not controlled (that is, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening - Allergic reaction to any GLP-1 agonist in the past (for example, exenatide, liraglutide) or to metacresol - Additional exclusion criteria at the end of the run-in phase: informed consent withdrawal; lack of compliance during the single-blind placebo run-in phase (>2 injections missed); and patient with any adverse event which precludes the inclusion in the study, as assessed by the investigator | |
| 9 | NCT02728622 | completed | 1 | phase 3 | ['ovarian cancer', 'peritoneal cancer', 'cancer of the fallopian tube'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['K65.1', 'K66.0', 'N99.4', 'N73.6', 'R88.0', 'Z49.32', 'Z49.02']"] | ['tamoxifen', 'chemotherapy'] | ['OC1=CC=C(C=C1)C1=C(C(=O)C2=CC=C(OCCN3CCCCC3)C=C2)C2=C(S1)C=C(O)C=C2', '[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC'] | Inclusion Criteria: - Patients with invasive epithelial ovarian, fallopian tube or peritoneal cancer, being resistant to treatment with platinum and a taxane, either given in combination or sequentially. - Patients with clinical progression during or within 6 months after end of treatment for primary disease or relapse. - Patients with stable disease after 6 courses of chemotherapy for primary disease or relapse if further treatment is indicated. - Patients with doubling of s-CA 125 to at least 70 IU/Ml within 3 months after end of treatment for primary disease or relapse. - Age must be at least 18 years. - Performance status must be 0-2 (WHO/ECOG, appendix 1). - Informed consent given according to ICH/EU GCP guidelines and local or national laws Exclusion Criteria: - Patients with symptomatic brain metastasis - Bilirubin greater than 2 x UNL (upper normal limits), white blood cell count below 3.0 x 109/L, neutrophil count below 1.5 x 109/L, platelets count below 100 x 109/L. - Active infection or other serious underlying medical condition which might prevent the patient from receiving treatment or to be followed. - Pregnant, lactating, or child bearing potential patients without adequate contraception - Previous treatment with Tamoxifen. | |
| 10 | NCT01378533 | unknown status | 1 | phase 3 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['epirubicin, cyclophosphamide, paclitaxel, carboplatin, g-csf'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O'] | Inclusion Criteria: 1. Patient must accept the modified radical mastectomy 2. Patients with histologically confirmed ER(-) PR(-) and HER-2(-) 3. Positive axillary lymph nodes;negative axillary lymph node with age< 35 years or Ⅲ grade or intravascular cancer embolus. 4. Age between 18 years to 65 years 5. Able to give informed consent 6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1. 7. Not pregnant, and on appropriate birth control if of child-bearing potential. 8. Adequate bone marrow reserve with ANC > 1000 and platelets > 100,000. 9. Adequate renal function with serum creatinine < 2.0. 10. Adequate hepatic reserve with serum bilirubin < 2.0, AST/ALT < 2X the upper limit of normal, and alkaline phosphatase < 5X the upper limit of normal. Serum bilirubin > 2.0 is acceptable in the setting of known Gilbert's syndrome. 11. No active major medical or psychosocial problems that could be complicated by study participation. Exclusion Criteria: 1. received neo-adjuvant therapy 2. Cardiac dysfunction documented by an ejection fraction less than the lower limit of the facility normal by multi-gated acquisition (MUGA) scan, or 45% by echocardiogram. -The rate of Disease recurrence 3. Uncontrolled medical problems. 4. Evidence of active acute or chronic infection. 5. Pregnant or breast feeding. 6. Hepatic, renal, or bone marrow dysfunction as detailed above. | |
| 11 | NCT00738881 | terminated | slow accrual | 0 | phase 3 | ['recurrent non-small cell lung carcinoma', 'stage iiia non-small cell lung cancer', 'stage iiib non-small cell lung cancer', 'stage iv non-small cell lung cancer'] | ["['D02.20', 'D02.21', 'D02.22']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['erlotinib hydrochloride', 'pemetrexed disodium'] | ['COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2', '[H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O'] | Inclusion Criteria: - Documented recurrence or disease progression of NSCLC - NSCLC must be confirmed by pathologic examination, either on initial diagnosis or disease recurrence/progression; mixed histology allowed if all components consistent with NSCLC - Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as >= 2.0 cm by conventional techniques or as >= 1.0 cm by spiral computed tomography (CT); if spiral CT is used, it must be used for both pre- and post- treatment tumor assessments - Prior radiation therapy is permitted as long as: - Recovered from the toxic effects of radiation treatment before study entry, except for alopecia - =< 25% of bone marrow radiated - Presence of measurable disease whether in-field disease progression/recurrence or disease outside the treatment fields of radiation port - Absolute neutrophil count (ANC) >= 1,500 uL - Platelet (PLT) >= 100,000 uL - Hemoglobin (Hgb) >= 10 g/dL - Total bilirubin: within normal institutional limits (WNL) OR direct bilirubin =< upper limit of normal (ULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN - International normalized ratio (INR) =< 1.5 - Calculated creatinine clearance >= 45 mL/min using the Cockcroft-Gault formula - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 - Negative pregnancy test done =< 7 days prior to pre-registration, for women of childbearing potential only - Ability to provide informed consent - Life expectancy >= 12 weeks - Tissue available and willing to submit tissue for central pathology review and EGFR evaluation; performed on original diagnostic/recurrent tissue (preferably paraffin-embedded tissue blocks); if institution unable to release tissue blocks, willing to submit 25 unstained slides (15 sections cut at 5 microns mounted on charged slides and 10 sections cut at 10 microns mounted on uncharged slides) - Must be previously treated for advanced disease with only 1 chemotherapy regimen which must contain cytotoxic agent(s); adjuvant/neoadjuvant treatment with cytotoxic agent(s) administered < 12 months (from date chemotherapy was started) prior to pre-registration will be considered as one prior treatment; NOTE: adjuvant/neoadjuvant treatment administered >= 12 months, use of targeted agents such as monoclonal antibodies prior to pre-registration will NOT be counted as one prior treatment; patient could have had adjuvant/neoadjuvant chemotherapy >= 12 months and 1 systemic chemotherapy regimen for metastatic or recurrent disease - Able to take folic acid, vitamin B12 supplementation, and dexamethasone - Able to permanently discontinue aspirin dose of >= 1.3 grams/day >= 10 days before and after pemetrexed treatment - Fertile patients must use effective contraception - Able to take folic acid, vitamin B_12 supplementation, and dexamethasone - Stable brain metastasis that have been treated with either whole brain radiation therapy or gamma knife surgery and are off steroid treatment for > 14 days prior to pre-registration, if applicable - Willingness to return to enrolling institution for treatment and follow-up Exclusion Criteria: - Any of the following: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception - Any clinically significant infection, at the treating physician's discretion - Known human immunodeficiency virus (HIV) positive patients - Impairment of gastrointestinal (GI) function, inability to swallow pills in the absence of a feeding tube, or GI disease that may significantly alter absorption of oral medications (e.g. ulcerative disease, uncontrolled nausea and vomiting, malabsorption syndromes, bowel obstruction, etc) - Serious condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study or increase the risk for serious adverse events - Any of the following prior therapies: - Prior radiation to > 25% of bone marrow - EGFR tyrosine kinase inhibitors - Pemetrexed - Chemotherapy =< 3 weeks prior to pre-registration - Mitomycin C/nitrosoureas =< 6 weeks prior to pre-registration - Immunotherapy =< 2 weeks prior to pre-registration - Biologic therapy =< 2 weeks prior to pre-registration - Gene therapy =< 2 weeks prior to pre-registration - Full field radiation therapy =< 4 weeks prior to pre-registration - Limited field radiation therapy =< 2 weeks prior to pre-registration - Major surgery (i.e., laparotomy), open biopsy, or significant traumatic injury =< 4 weeks prior to pre-registration or anticipation of need for major surgical procedure during the course of the study; minor surgery =< 2 weeks prior to pre-registration; insertion of a vascular access device is not considered major or minor surgery in this regard - Other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation) =< 4 weeks prior to pre-registration - Steroid therapy for brain metastasis =< 14 days prior to pre-registration - Symptomatic serosal effusion (>= Common Terminology Criteria for Adverse Events [CTCAE] v3.0 grade 2 dyspnea) that is not amenable to drainage prior to pre-registration - Other invasive solid or hematologic malignancy; exceptions: prior malignancy was diagnosed and definitively treated >= 5 years previously with no subsequent evidence of recurrence; patients with a history of low-grade (Gleason score =< 6) localized prostate cancer will be eligible even if diagnosed < 3 years prior to pre-registration; these patients may continue on medications concomitantly to maintain their disease remission as necessary; patients with carcinoma in situ, regardless of organ involvement, or non-melanoma cutaneous carcinomas are eligible if these were definitively treated >= 3 years previously with no subsequent evidence of recurrence; Note: patients with breast cancer that was definitively treated > 5 years earlier but continue to receive aromatase inhibitors are NOT eligible - Only non-measurable disease, defined as all other lesions, including small lesions whose longest diameter measures < 2 cm with conventional techniques or < 1.0 cm with spiral CT, and truly non-measurable lesions, which include the following as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria dated June 1999: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Inflammatory breast disease - Lymphangitis cutis/pulmonis - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - Single disease site in prior radiation field - Any of the following concurrent severe and/or uncontrolled medical conditions: - Angina pectoris - History of congestive heart failure =< 3 months prior to pre-registration, unless ejection fraction > 40% - Myocardial infarction =< 6 months prior to pre-registration - Cardiac arrhythmia - Diabetes mellitus - Hypertension - Any other severe underlying diseases which are, in the judgment of the investigator, inappropriate for entry into this study - Respiratory symptoms > CTCAE grade 1 |
| 12 | NCT01829243 | completed | 0 | phase 3 | ['fibromyalgia', 'neurocognition'] | ["['M79.7']"] | ['milnacipran', 'placebo'] | ['CCN(CC)C(=O)C1(CC1CN)C1=CC=CC=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Age 18 to 65 years. - Specific diagnosis of FM by the participant's rheumatologist or physician, including written confirmation, from a physician, of the FM diagnosis. - Confirmation of the FM diagnosis by American College of Rheumatology Criteria and a physical tender point examination. - Ability to give informed consent. - If female, nonpregnant/nonlactating. - If a sexually active female of reproductive potential, must be using adequate contraception (i.e., oral contraceptives, barrier protection, or prior tubal ligation) during the trial. Exclusion Criteria: - Bipolar disorders, any psychotic disorder. - the existence of concomitant rheumatological disorders, including rheumatoid arthritis, systemic lupus erythematosus, Hashimoto's disease, Sjogren's syndrome or scleroderma. - Substance dependence (except nicotine dependence) in the previous 3 months. - Currently suicidal or high suicide risk. - Serious or unstable medical disorders. - Any psychotropic drug treatment in the previous 2 weeks before screening. - A positive urine pregnancy test. - Screening laboratory values three times the limits of normal or judged clinically significant by the investigator. - History of hypersensitivity to milnacipran. - Seizure disorder, traumatic brain injury, any CNS disorder that affects cognitive status. - Concomitant meds: A minimum of 30 days on stable dose of analgesics and a minimum of 4 week washout from antidepressants and fibromyalgia specific medication ( e.g. pregabalin, neurontin) and supplements ( St John's wort, SAM-E). - Narrow angle glaucoma. | |
| 13 | NCT00151424 | completed | 0 | phase 3 | ['schizophrenia'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['asenapine', 'placebo', 'olanzapine'] | ['OC(=O)\\C=C/C(O)=O.CN1CC2C(C1)C1=C(OC3=CC=CC=C23)C=CC(Cl)=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CNCCC(OC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1'] | Inclusion Criteria: - Currently suffering from an acute exacerbation of schizophrenia. Exclusion Criteria: - Have an uncontrolled, unstable medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis. | |
| 14 | NCT01440569 | completed | 1 | phase 3 | ['acquired immunodeficiency syndrome', 'hiv infections'] | ["['D84.9', 'D81.9', 'D83.9', 'D84.821', 'B20', 'D82.2', 'D84.822']", "['Z21']"] | ['cobi', 'drv', 'nrtis'] | ['CC(C)C1=NC(CN(C)C(=O)N[C@@H](CCN2CCOCC2)C(=O)N[C@H](CC[C@H](CC2=CC=CC=C2)NC(=O)OCC2=CN=CS2)CC2=CC=CC=C2)=CS1', '[H][C@@]12CCO[C@]1([H])OC[C@@H]2OC(=O)N[C@@H](CC1=CC=CC=C1)[C@H](O)CN(CC(C)C)S(=O)(=O)C1=CC=C(N)C=C1'] | Inclusion Criteria: - Adult ≥ 18 years males or non-pregnant females - Ability to understand and sign a written informed consent form - General medical condition that does not interfere with the assessments and the completion of the trial - Treatment Naive: No prior use of any approved or investigational antiretroviral drug for any length of time OR - Treatment Experienced: Stable antiretroviral regimen for at least 12 weeks prior to screening - Plasma HIV-1 RNA levels ≥ 1000 copies/mL at Screening - Screening genotype report shows full sensitivity to two nucleoside analogue reverse transcriptase inhibitors (NRTIs) and no darunavir resistance-associated mutations - Normal electrocardiogram (ECG) - Hepatic transaminases ≤ 2.5 × upper limit of normal (ULN) - Total bilirubin ≤ 1.5 mg/dL - Adequate hematologic function - Serum amylase ≤ 2 × ULN and serum lipase ≤ 3 × ULN - Adequate renal function: Estimated glomerular filtration rate ≥ 80 mL/min - Females of childbearing potential must agree to utilize protocol-recommended methods of contraception, or be nonheterosexually active, practice sexual abstinence or have a vasectomized partner from Screening throughout the duration of the study period and for 30 days following the last dose of study drug. - Male subjects must agree to utilize protocol-recommended methods of contraception during heterosexual intercourse from the Screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product or be nonheterosexually active, practice sexual abstinence, or be vasectomized. Exclusion Criteria: - Previous or current use of darunavir - A new AIDS-defining condition diagnosed within the 30 days prior to Screening - Females who are breastfeeding - Positive serum pregnancy test (if female of childbearing potential) - Proven or suspected acute hepatitis in the 30 days prior to study entry - Subjects receiving drug treatment for hepatitis C virus (HCV), or subjects who are anticipated to receive treatment for HCV during the course of the study - Have a history of ongoing active liver disease or experiencing decompensated cirrhosis irrespective of liver enzyme levels - Have an implanted defibrillator or pacemaker - Current alcohol or substance use that may interfere with subject study compliance - A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma - Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline - Participation in any other clinical trial - Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements. - Subjects receiving ongoing therapy with any of the medications, including drugs not to be used with cobicistat, darunavir, or investigator selected NRTIs; or subjects with any known allergies to cobicistat tablets, darunavir tablets or contraindications for the 2 NRTIs as part of the regimen. | |
| 15 | NCT01244815 | completed | 1 | phase 3 | ['bipolar disorder, pediatric'] | ["['R63.31', 'R63.32', 'G47.33', 'Z68.51', 'Z68.54', 'Z68.52', 'Z68.53']"] | ['asenapine', 'placebo to match asenapine', 'rescue medication'] | ['OC(=O)\\C=C/C(O)=O.CN1CC2C(C1)C1=C(OC3=CC=CC=C23)C=CC(Cl)=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion criteria: - Participants who (or whose parent/legal representative) are able to give written informed consent. - Participants must be 10 years of age or older and 17 years of age or younger at the time of treatment assignment (randomization). - Participants must have a diagnosis of bipolar I disorder, confirmed by structured interview at screening. - Participants must not be pregnant or lactating, and those who are sexually active or become sexually active during the trial, and of child-bearing potential, must be using a medically accepted form of birth control. - Participants will be required to have stopped taking certain psycho-active medications prior to baseline. - Participants must have a caregiver, or other responsible person living with them who agrees to provide support to the participant to ensure study and procedure compliance. Exclusion criteria: - Diagnosis of bipolar II disorder, or other form of bipolar or psychotic disorder. - Known or suspected mental retardation. - Substance abuse, or dependence, within the past 6 months. - There is risk of self-harm or harm to others. - There is a history of tardive dyskinesia or dystonia. - Pregnancy or lactation during the study. - History of seizure disorder. - Participation in any other clinical trial at the same time. - A family member who is part of the study staff or is directly involved with the study. - Other medical conditions determined by the study staff to possibly interfere with the study safety and efficacy evaluations. | |
| 16 | NCT00649025 | completed | 1 | phase 3 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['flutiform 250/10', 'skp-fluticasone', 'flovent fluticasone hfa'] | ['[H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C'] | Main Inclusion Criteria: - ≥ Age 12 years at the Screening Visit. - History of asthma for 12 months prior to the Screening Visit. - Documented use of an inhaled corticosteroid for at least 4 weeks prior to the Screening Visit. - Steroid-requiring patient - patients must demonstrate (1) an FEV1 of 40% to 80% (inclusive) of predicted normal values at both the Screening and Baseline Visits and (2) documented reversibility within 12 months of the Screening Visit, defined as a ≥ 15% Main Exclusion Criteria: - Life-threatening asthma within the past year or during the Run-In Period. - History of systemic (oral or injectable) corticosteroid medication within 3 months before the Screening Visit. - An upper or lower respiratory infection within 4 weeks prior to the Screening Visit or during the Run-In Period. - Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease [COPD], cystic fibrosis, bronchiectasis). - A smoking history equivalent to "10 pack years" (i.e., at least 1 pack of 20 cigarettes /day for 10 years or 10 packs/day for 1 year, etc.). - Current smoking history within 12 months prior to the Screening Visit. - Previous exposure to FlutiForm | |
| 17 | NCT01134393 | completed | 1 | phase 3 | ['hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['telmisartan/amlodipine'] | ['CCCC1=NC2=C(C=C(C=C2C)C2=NC3=CC=CC=C3N2C)N1CC1=CC=C(C=C1)C1=CC=CC=C1C(O)=O'] | Inclusion criteria: 1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation 2. Age 18 years or older 3. Patients with uncontrolled hypertension as defined SBP > 140 mmHg and SBP > 130 mmHg in patients with diabetes or renal impairment or DBP > 90 mmHg and DBP >80 mmHg in patients with diabetes or renal impairment after at least an 6 weeks of stable treatment with antihypertensive medication defined as treatment with the clinically recommended dose of a single RAAS blocking agent (Angiotensin Converting Enzym inhibition, AII Receptor Blocker and Direct Renin Inhibitor) at entering the trial. Renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min Exclusion criteria: 1. Pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. 2. Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma). 3. Mean in-clinic seated cuff Systolic BP >180 mmHg and SBP >160 mmHg in patients with diabetes or renal impairment or Diastolic BP >110 mmHg and DBP >100 mmHg in patients with diabetes or renal impairment. Renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min. 4. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dl (or >265 ¿mol/L) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment. 5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney. 6. Clinically relevant hypokalaemia or hyperkalaemia (i.e., <3.5 or >5.5 mEq/L). 7. Uncorrected sodium or volume depletion. 8. Primary aldosteronism. 9. Hereditary fructose intolerance. 10. Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.1). 11. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator. 12. Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency (defined as elevated levels of >2x bilirubin or >2x transaminases values). (Refer to Appendix 10.3) 13. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists. 14. History of drug or alcohol dependency within six months prior to signing the informed consent form. 15. Any investigational drug therapy within one month of signing the informed consent. 16. Known hypersensitivity to any component of the trial drugs (telmisartan or amlodipine). 17. History of non-compliance or inability to comply with prescribed medications or protocol procedures. 18. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication. | |
| 18 | NCT00300755 | completed | 1 | phase 3 | ['gastroesophageal reflux'] | ["['K21.9', 'K21.00', 'K21.01']"] | ['pantoprazole sodium enteric-coated spheroid'] | ['COC1=C(OC)C(CS(=O)C2=NC3=C(N2)C=C(OC(F)F)C=C3)=NC=C1'] | Inclusion Criteria: - Ability to undergo endoscopy with required biopsy - Ages 1 through 5 years - Endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis or positive histologic evidence of esophagitis consistent with GERD Other inclusions apply. Exclusion Criteria: - History or presence of upper gastrointestinal anatomic or motor disorders - Known current or active cow's milk allergy - Malignancy - Other exclusions apply. | |
| 19 | NCT00598806 | completed | 0 | phase 3 | ['bladder cancer'] | ["['D30.3', 'C67.5', 'C67.9', 'C79.11', 'C67.0', 'C67.1', 'D41.4']"] | ['apaziquone', 'placebo'] | ['CN1C(\\C=C\\CO)=C(CO)C2=C1C(=O)C=C(N1CC1)C2=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: All of the following questions must be answered "Yes" in order for the patient to participate in the study. 1. Has the patient given written informed consent? 2. Is the patient at least 18 years old? 3. Does the patient have transitional cell carcinoma of the bladder with clinically apparent tumor Ta, grade G1-G2? 4. If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception? 5. If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days? 6. Is the patient willing and able to abide by the protocol? Exclusion Criteria: All of the following questions must be answered "No" in order for the patient to participate in the study. 1. Does the patient have more than 5 bladder tumors? 2. Does any single bladder tumor exceed 3.5 cm in diameter? 3. Does the patient have a single, primary bladder tumor <0.5 cm and has no previous diagnosis of bladder cancer? 4. Has the patient ever received EOquin(r)? 5. Does the patient have, or has the patient ever had, any bladder tumor known to be other than tumor Ta or grade G1 or G2 (low grade [WHO/ISUP classification])? 6. Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma? 7. Does the patient have, or has the patient ever had, carcinoma in situ (CIS)? 8. Does the patient have an active urinary tract infection? 9. Does the patient have a bleeding disorder or a screening platelet count < 100 x 109/L? 10. Does the patient have any unstable medical condition that would make it unsafe for him/her to undergo TURBT under general or spinal anesthesia? 11. Does the patient have screening hemoglobin < 10 mg/dL, a screening absolute neutrophil count < 1.5 x 109/L? 12. Does the patient have a known immunodeficiency disorder? 13. Has the patient received any investigational treatment within the past 30 days? 14. Is the patient breast feeding? 15. Does the patient have a history of interstitial cystitis? 16. Does the patient have a history of allergy to red color food dye? 17. Has the patient had transitional cell carcinoma of the bladder within the past 4 months? | |
| 20 | NCT00216476 | completed | 1 | phase 3 | ['schizophrenia', 'psychotic disorders'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']", "['F23', 'F24', 'F12.159', 'F12.259', 'F12.150', 'F12.151', 'F12.250']"] | ['aripiprazole', 'risperidone long acting injectable (lai)', 'quetiapine'] | ['ClC1=CC=CC(N2CCN(CCCCOC3=CC4=C(CCC(=O)N4)C=C3)CC2)=C1Cl', 'OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12', 'OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12'] | Inclusion Criteria: - Diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) - Patients currently treated with oral risperidone, olanzapine or a conventional neuroleptic monotherapy at doses not exceeding 6 mg risperdal, 20 mg olanzapine, or a conversion dose of 10 mg haloperidol for oral conventional agents - Patients who are stable (judged clinically stable by the investigator and on a stable dose of medication for 4 weeks or longer) but not optimally treated (non-satisfactory treatment regarding symptoms or adverse events) Exclusion Criteria: - Diagnosis other than schizophrenia or schizoaffective disorder by DSM-IV Axis I criteria - Patients being treated with antipsychotic agents other than oral risperidone, olanzapine or conventional oral neuroleptic agents - Patients with known hypersensitivity to oral risperidone, quetiapine, aripiprazole, or who are known non-responders to oral risperidone, quetiapine, aripiprazole or to previous treatment with at least 2 antipsychotic agents - Patients treated with mood stabilizers or antidepressants who are not on stable dose for at least 3 months before study initiation - Pregnant or nursing females, or those lacking adequate contraception | |
| 21 | NCT00345618 | completed | 1 | phase 3 | ['embolism', 'thrombosis'] | ["['I27.82', 'I76', 'O88.02', 'O88.82', 'T79.0XXS', 'T79.1XXS', 'O03.2']", "['I81', 'K64.5', 'I51.3', 'I67.6', 'I74.11', 'I74.5', 'I74.8']"] | ['idrabiotaparinux sodium', 'warfarin', 'placebo (for idrabiotaparinux sodium)', 'avidin', 'placebo (for warfarin)', 'enoxaparin'] | ['S1SSSSSSS1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', '[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]'] | Inclusion Criteria: - Symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis Exclusion Criteria: - End stage renal failure, hepatic failure, uncontrolled hypertension; - Active bleeding or high risk for bleeding; - Pregnancy or childbearing potential without proper contraceptive measures, threatened abortion. - Breastfeeding. - Known allergy to idraparinux or idrabiotaparinux, avidin or egg proteins; - hypersensitivity to warfarin, enoxaparin, heparin or pork product; or any other contraindication listed in the labelling of warfarin or enoxaparin; - Indication of prolonged anticoagulation therapy for other reason than PE; - Life expectancy < 6 months; | |
| 22 | NCT00391222 | completed | 1 | phase 3 | ['bipolar disorder'] | ["['F31.81', 'F31.89', 'F31.9', 'F25.0', 'F31.0', 'F31.31', 'F31.32']"] | ['olanzapine', 'placebo', 'risperidone long acting injectable (lai)'] | ['CNCCC(OC1=CC=C(C=C1)C(F)(F)F)C1=CC=CC=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12'] | Inclusion Criteria: - Diagnosis of bipolar I disorder as defined by DSM-IV-TR criteria. All diagnoses will be confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.). Patients who present with additional signs or symptoms compatible with Axis I diagnoses of social anxiety disorder or generalized anxiety disorder are acceptable. All other comorbid or active Axis I diagnoses are excluded. Personality disorders as defined by DSM IV TR criteria are acceptable, with the exception of antisocial and borderline personality disorders - Must be currently experiencing a manic or mixed episode (acute - YMRS >20 and CGI-S =>4 [moderate]) or must be between mood episodes (non-acute - YMRS <12 and CGI-S=<3 [mild]) - Must have had at least 2 bipolar mood (manic, mixed manic, or depressed) episodes, exclusive of the current episode (if applicable), during the last year. For non-acute subjects (YMRS <12 and CGI-S=<3 [mild]), one manic episode must have occurred within 4 months of enrollment - Patients who are non-acute (YMRS <12 and CGI-S =<3 [mild]) and are currently receiving an antipsychotic other than risperidone or a mood stabilizer must have received this other medication at the same dosage for a minimum of 4 weeks and must be either experiencing problems of safety or tolerability with the antipsychotic or mood stabilizer or request a change of medication Exclusion Criteria: - No history of more than 4 mood episodes each year (rapid cycling) during the last 2 years prior to screening - No history of ADHD, anxiety disorder, or panic disorder as the primary diagnosis - Not meeting DSM-IV-TR criteria for a hypomanic or depressive episode - Not meeting DSM-IV-TR criteria for any comorbid or active Axis I disorder other than those specifically allowed in the Inclusion Criteria - Not meeting DSM-IV-TR criteria for antisocial or borderline personality disorder - Not having a chronic or serious general medical illness, including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic (including seizure disorder), or hematologic disease as determined by the clinical judgment of the investigator | |
| 23 | NCT01419197 | completed | 1 | phase 3 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['trastuzumab emtansine', "treatment of physician's choice"] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'COC1=CC=CC=C1OC1=C(NS(=O)(=O)C2=CC=C(C=C2)C(C)(C)C)N=C(N=C1OCCO)C1=NC=CC=N1'] | Inclusion Criteria: - Adult participants ≥ 18 years of age. - Histologically or cytologically documented breast cancer. - Metastatic or unresectable locally advanced/recurrent breast cancer. - HER2-positive disease by prospective laboratory confirmation. - Disease progression on the last regimen received as defined by the investigator. - Prior treatment with an trastuzumab, a taxane, and lapatinib. - Disease progression after at least two regimens of HER2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting. - Adequate organ function, as evidenced by laboratory results. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. - Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or multi gated acquisition scan. Exclusion Criteria: - Chemotherapy ≤ 21 days before first study treatment. - Trastuzumab ≤ 21 days before first study treatment. - Lapatinib ≤ 14 days before first study treatment. - Prior enrollment in a trastuzumab emtansine containing study, regardless whether the patient received prior trastuzumab emtansine. - Brain metastases that are untreated or symptomatic, or require any radiation, surgery or corticosteroid therapy to control symptoms within 1 month of randomization. | |
| 24 | NCT01947855 | completed | 1 | phase 3 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['placebo', 'empagliflozin', 'placebo', 'placebo', 'empagliflozin', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CN(C)C(=N)NC(N)=N', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CN(C)C(=N)NC(N)=N', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion criteria: - Diagnosis of type 2 diabetes mellitus prior to informed consent - Male and female patients on diet and exercise regimen for 12 weeks prior to informed consent who are: - drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or, - pre-treated with one oral antidiabetic drug (except sulfonylurea and thiazolidinedione); the present antidiabetic therapy has to be unchanged for at least 12 weeks prior to the informed consent. (Sulfonylurea is permitted as pre-treatment drug only if the dose is equal or less than a half of daily maximum approval dose.) - Glycosylated haemoglobin (HbA1c) at Visit 1 (screening) - for patients without antidiabetic therapy : HbA1c >=7.0 to =<10.0% - for patients with one oral antidiabetic drug : HbA1c >=7.0 to =<9.5% Exclusion criteria: - Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L) - Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 (moderate and severe renal impairment, modification of diet in renal disease (MDRD) formula) - Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent - Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN) | |
| 25 | NCT00768300 | terminated | lack of efficacy | 0 | phase 3 | ['idiopathic pulmonary fibrosis'] | ["['J84.112']"] | ['ambrisentan', 'placebo'] | ['COC([C@H](OC1=NC(C)=CC(C)=N1)C(O)=O)(C1=CC=CC=C1)C1=CC=CC=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Male or females from 40 to 80 years of age - Diagnosis of IPF - Honeycombing (fibrosis in the lung) on high-resolution computerised tomography (HRCT) scan of less than or equal to 5% - Willing and able to have 2 right heart catheterizations performed - Willing to have monthly lab tests to monitor liver function - Able to perform the 6 minute walk test (indicated adequate physical function) - Must have meet lung function requirements - Normal liver function tests - Negative serum pregnancy test - Willing to use at least 2 reliable methods of contraception - Able to understand and willing to sign informed consent form Exclusion Criteria: - No restrictive lung disease (other than usual interstitial pneumonia or IPF) - No obstructive lung disease - No recent or active respiratory exacerbations - No recent hospitalization for an IPF exacerbation - No recent history of alcohol abuse - Chronic sildenafil (or same drug class) use for pulmonary hypertension - Chronic treatment with certain medications for IPF within 30 days of randomization - No other serious medical conditions |
| 26 | NCT00090051 | completed | 1 | phase 3 | ['chronic lymphocytic leukemia'] | ["['C91.11', 'C91.12', 'C91.10']"] | ['rituximab', 'fludarabine phosphate', 'cyclophosphamide'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'NC1=NC(F)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O', 'ClCCN(CCCl)P1(=O)NCCCO1'] | Inclusion Criteria: - Age ≥18 years - Established diagnosis of B-cell CLL by NCI Working Group criteria - ≤1 previous line of chemotherapy - Expected survival >6 months - Acceptable hematologic status, liver function, renal function, and pulmonary function - Negative serum pregnancy test for both pre-menopausal women and for women who are < 2 years after the onset of menopause - Written informed consent Exclusion Criteria: - Prior treatment with interferon, rituximab or other monoclonal antibody - Prior allogeneic bone marrow transplant (BMT) or autologous BMT or peripheral stem cell transplant (PBSCT) or patients who are considered to be candidates for allogeneic or autologous BMT or PSCT as assessed by their treating physician - Fertile men or women of childbearing potential not using adequate contraception - Severe Grade 3 or 4 non-hematological toxicity or prolonged (> 2 weeks) Grade 3 or 4 cytopenia on prior fludarabine or nucleoside analogue regimen - History of fludarabine-induced or clinically significant autoimmune cytopenia - History of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low-grade early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent. - Medical conditions requiring long term use (> 1 month) of systemic corticosteroids - Active bacterial, viral, or fungal infection requiring systemic therapy - Severe cardiac disease - Seizure disorders requiring anticonvulsant therapy - Severe chronic obstructive pulmonary disease with hypoxemia - Uncontrolled diabetes mellitus or hypertension - Transformation to aggressive B-cell malignancy. - Known infection with HIV, HCV, or hepatitis B - Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study - Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins - Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent | |
| 27 | NCT00603291 | completed | 1 | phase 3 | ['obesity'] | ["['E66.8', 'E66.9', 'E66.1', 'O99.214', 'O99.215', 'O99.210', 'O99.211']"] | ['lorcaserin 10 mg once daily (qd)', 'lorcaserin 10 mg twice a day (bid)', 'matching placebo'] | ['COC1=CC=CC=C1OCC(O)CO', 'COC1=CC=CC=C1OCC(O)CO', 'CC1=CC(O)=CC(C)=C1Cl'] | Inclusion Criteria: - Overweight/obese men and women with type 2 diabetes mellitus that is managed with oral anti-hyperglycemic agent(s). - Body mass index (BMI) 27 to 45 kg/m2, inclusive. - Ability to complete a 1 year study Exclusion Criteria: - Pregnancy - Use of insulin in any form, exenatide (Byetta) or pramlintide (Symlin) within 3 months prior to screening - History of symptomatic heart valve disease - Serious or unstable current or past medical conditions | |
| 28 | NCT01064687 | completed | 1 | phase 3 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['ly2189265', 'exenatide', 'placebo', 'metformin', 'pioglitazone'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CSCC[C@H](N)C(O)=O', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | Inclusion Criteria: - Type 2 Diabetes (T2D) not well controlled on 1, 2, or 3 oral antidiabetic medications 1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication 2. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications - Able to tolerate minimum dose of 1500 milligrams (mg) metformin a day and 30 mg pioglitazone per day. - Willing to inject subcutaneous (SC) medication up to 2 times per day - Stable weight for 3 months prior to screening - Body mass index (BMI) between 23 and 45 kilograms per meter squared (kg/m^2) - Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug. Exclusion Criteria: - Type 1 Diabetes - HbA1c equal to or less than 6.5 before randomization or at randomization - Chronic insulin use - Taking drugs to promote weight loss by prescription or over the counter - Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled - History of fluid retention or edema - History of Heart Failure New York Heart Classification II, III, or IV or acute myocardial infarction or stroke within 2 months of screening - Gastrointestinal (GI; stomach) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility - Hepatitis or liver disease or alanine transaminase (ALT) greater than 2.5 times the upper limit of normal - Acute or chronic pancreatitis of any form - Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatine clearance of less than 60 milliliters per minute (mL/min) - History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer - A serum calcitonin greater than or equal to 20 picograms per milliliter (pg/mL) at screening - Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis - History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years - Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing - Organ transplant except cornea - Have enrolled in another clinical trial within the last 30 days - Have previously signed an informed consent or participated in a LY2189265 (dulaglutide) study - Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening | |
| 29 | NCT00264550 | completed | 1 | phase 3 | ['rheumatoid arthritis'] | ["['M06.9', 'M05.9', 'M06.08', 'M06.00', 'M06.011', 'M06.012', 'M06.019']"] | ['golimumab 100 mg', 'golimumab 50 mg', 'methotrexate', 'placebo injection', 'placebo capsules'] | ['CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O', '[Na+].[Cl-]', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ACR) for at least 3 months prior to screening - Must have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg/week for at least 3 months prior to screening, and have a MTX dose of >=15 mg/week and <=25 mg/week and stable for at least 4 weeks prior to screening - Have active RA as defined by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and baseline, and at least 2 of the following 4 criteria: a)C-reactive protein (CRP) >=1.5 mg/dL at screening or erythrocyte sedimentation rate (ESR) by Westergren method of >= 28 mm in the first hour at screening or baseline, b)Morning stiffness of >= 30 minutes at screening and baseline, c)Bone erosion by x-ray and/or magnetic resonance imaging (MRI) prior to first administration of study agent, d)Anti-cyclic citrullinated peptide (anti-CCP) antibody-positive or rheumatoid factor (RF) positive at screening - If using oral corticosteroids, must be on a stable dose equivalent to <= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent - Are considered eligible according to specified tuberculosis (TB) screening criteria Exclusion Criteria: - Have inflammatory diseases other than RA that might confound the evaluation of the benefit of golimumab therapy - Have had treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives other than MTX, during the 4 weeks prior to the first administration of study agent - Have had prior treatment with biologic anti-tumor necrosis factor (TNF) drugs (infliximab, etanercept, adalimumab) - Have had history of, or ongoing, chronic or recurrent infectious disease. - Have serious infection within 2 months prior to first administration of study agent - Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening | |
| 30 | NCT00128531 | completed | 1 | phase 3 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['leuprolide acetate'] | ['CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O'] | Inclusion Criteria: - Males >/= 18 years of age, with histologically proven carcinoma of the prostate, who might benefit from medical androgen deprivation therapy - Life expectancy of at least 1 year - World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1, or 2 - Adequate renal function at screening as defined by serum creatinine </= 1.6 times the ULN (upper limit of normal) for the clinical laboratory - Adequate and stable hepatic function as defined by bilirubin </= 1.5 times the ULN and transaminases (i.e. SGOT, SGPT) </= 2.5 times the ULN for the clinical laboratory at screening - Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study - Signed written informed consent prior to inclusion in the study Exclusion Criteria: - Evidence of brain metastases, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms - Evidence of spinal cord compression, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms - Evidence of severe urinary tract obstruction with threatening urinary retention, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms - Excruciating, severe pain from extensive osseous deposits, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms - Testosterone levels < 1.5 ng/mL at screening, locally determined at the laboratory of each clinical site - Previous cancer systemic therapy such as chemotherapy, immunotherapy (e.g. antibody therapies, tumor-vaccines), biological response modifiers (e.g. cytokines) within 3 months of baseline - Previous hormonal therapy for treatment of prostate cancer, such as luteinising hormone-releasing hormone (LHRH) analogues (e.g. Lupron®, Zoladex®, etc.) [no wash-out allowed] - Previous treatment with androgen receptor (AR) blockers, such as Casodex®, Fugerel®, Megace®, Androcur® (no wash-out allowed) - Previous orchiectomy, adrenalectomy or hypophysectomy - Previous prostatic surgery (e.g. radical prostatectomy, transurethral resection of the prostate [TUR-P]) within 2 weeks of baseline - Previous local therapy to the primary tumor with a curative attempt other than surgery (external beam radiotherapy, brachytherapy, thermotherapy, cryotherapy) within 2 weeks of baseline - Any investigational drug within 5 half-lives of its physiological action or 3 months (whichever is longer) before baseline - Administration of 5-alpha-reductase inhibitors (Proscar®, Avodart®, Propecia®) within 3 months before baseline - Over-the-counter (OTC) or alternative medical therapies which have an estrogenic or anti-androgenic effect (i.e., PC-SPES, saw palmetto, Glycyrrhiza®, Urinozinc®, dehydroepiandrosterone [DHEA]) within the 3 months before baseline - Hematological parameters (RBC, total and differential WBC count, platelet count, hemoglobin, hematocrit) outside 20% of the upper or lower limits of normal (ULN, LLN) for the clinical laboratory at screening - Co-existent malignancy, according to the Investigator's opinion - Uncontrolled congestive heart failure, myocardial infarction or a coronary vascular procedure (e.g. balloon angioplasty, coronary artery bypass graft) or significant symptomatic cardiovascular disease(s) within 6 months before baseline; resting uncontrolled hypertension: (>/= 160/100 mmHg) or symptomatic hypotension within 3 months before baseline - Venous thrombosis within 6 months of baseline - Insulin-dependent diabetes mellitus - History of drug and/or alcohol abuse within 6 months of baseline - Serious concomitant illness(es) or disease(s) [e.g., hematological, renal, hepatic, respiratory, endocrine, psychiatric] that may interfere with, or put patients at additional risk for, their ability to receive the treatment outlined in the protocol - Patients receiving anticoagulants who have prothrombin and partial thromboplastin times outside of the normal range for the laboratory assays; patients who are on anticoagulation or antiplatelet medications (e.g. dipyridamole, ticlopidine, warfarin derivatives) who are not receiving a stable dose for 3 months before baseline; patients who are receiving warfarin-derivative anticoagulants who do not have an International Normalized Ratio (INR) in the therapeutic range for the clinical indication for which the anticoagulant has been prescribed. - Blood donations/losses within 2 months of baseline, apart from previous prostatic surgery patients (see earlier exclusion [9]; please note that these patients should not be included in the pharmacokinetic [PK] group) - Known hypersensitivity to GnRH, GnRH agonist, including any LHRH analogues, or any excipients of the study formulation - History of the following prior to the study: - immunization (within 4 weeks of baseline); - flu shots (within 2 weeks of baseline); - anaphylaxis; - skin disease which would interfere with injection site evaluation; - dermatographism will be documented at screening and followed up while on treatment. | |
| 31 | NCT00724048 | completed | 0 | phase 2/phase 3 | ['huntington disease'] | ["['G10']"] | ['acr16 10 mg', 'acr16 22.5 mg', 'acr16 45 mg'] | ['CCCN1CCC(CC1)C1=CC=CC(=C1)S(C)(=O)=O', 'CCCN1CCC(CC1)C1=CC=CC(=C1)S(C)(=O)=O', 'CCCN1CCC(CC1)C1=CC=CC(=C1)S(C)(=O)=O'] | Inclusion Criteria: - Able to provide written Informed Consent prior to any study related procedure, including consent to genotyping of the CYP2D6 gene. - Clinical features of HD, and a positive family history and/or the presence of ≥ 36 CAG repeats in the Huntington gene. - Male or female age ≥ 30 years. - Willing and able to take oral medication and to comply with the study specific procedures. - Ambulatory, being able to travel to the assessment center, and judged by the Investigator as likely to be able to continue to travel for the duration of the study. - Availability of a caregiver or family member to accompany the subject to two visits. - A sum of ≥ 10 points on the mMS at the screening visit. - For subjects taking allowed antidepressants or other psychotropic medication , the dosing of medication must have been kept constant for at least 6 weeks before enrollment. Exclusion Criteria: - Treatment with any antipsychotic medication (neuroleptics) within 8 weeks of enrollment, or at any time point during the study period. - Use of tetrabenazine within 12 weeks of enrollment, or at any time during the study period. - Treatment with any investigational product within 4 weeks of enrollment. - Use of tricyclic antidepressants or class I antiarrhythmics within 6 weeks of enrollment, or at any time during the study period. - Use of concomitant medication that may lower the seizure threshold within 6 weeks of enrollment, or at any time during the study period . - Use of metoclopramide within 12 weeks of enrollment, or at any time during the study period. - Subjects currently receiving deep brain stimulation (DBS). - Subjects with a history of surgical procedures aiming to improve the symptoms of Huntington disease, such as neural transplantations, lesions of the central nervous system, infusions of neurotrophic agents or previous attempts of deep brain stimulation. - Subjects previously randomized into this study. - A prolonged QTc interval at Screening Visit (defined as a QTc interval of > 450 msec for males or > 470 msec for females), or other clinically significant heart conditions as judged by the investigator. - Creatinine clearance <40mL/min as measured at the screening visit. - Any clinically significant, abnormal, baseline laboratory result which in the opinion of the Investigator, affects the subjects' suitability for the study or puts the subject at risk if he/she enters the study. - Clinically significant hepatic or renal impairment. - Subjects with a known history of epilepsy or a history of febrile seizure(s) or seizure(s) of unknown cause. - Severe intercurrent illness, which, in the opinion of the Investigator, may put the subject at risk when participating in the trial or may influence the results of the trial or affect the subjects' ability to take part in the trial. - Alcohol and/or drug abuse as defined by DSM IV-TR criteria for Substance Abuse - this includes the illicit use of cannabis within the last 12 months prior to Screening Visit - Subjects with suicidal ideation as defined as a positive score on criteria for major depressive episode, item A9 on the DSM -IV-TR criteria for a Major Depressive Episode - Females who are pregnant or lactating or who intend to become pregnant during the study period. - Females who are of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. (Females of child bearing potential taking acceptable contraceptive precautions can be included) - Known allergy to any ingredients of the trial medication or placebo - Any previous participation in a clinical study with ACR16. | |
| 32 | NCT00670501 | completed | 0 | phase 3 | ['osteoporosis, postmenopausal'] | ["['N95.0', 'N95.2']"] | ['teriparatide', 'teriparatide', 'placebo', 'calcium supplement', 'vitamin d supplement'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', '[Ca++].[Ca++].[Ca++].OC(CC([O-])=O)(CC([O-])=O)C([O-])=O.OC(CC([O-])=O)(CC([O-])=O)C([O-])=O'] | Inclusion Criteria: - Ambulatory, postmenopausal women. - A minimum of either one moderate or two mild atraumatic vertebral fractures, and a minimum of seven evaluable nonfractured vertebrae. - Hip BMD or lumbar spine BMD measurement at least 1.0 standard deviation (SD) below the average bone mass for young, healthy women (T-score) only in patients with fewer than two moderate fractures or in patients previously treated with therapeutic doses of bisphosphonates or fluorides - Normal or clinically nonsignificant abnormal laboratory values (serum calcium, PTH(1-84), & urine calcium must be within normal limits at baseline; 25-hydroxyvitamin D must be between the lower limit of normal & 3 times the upper limit of normal at baseline). Exclusion Criteria: - Fractures in areas of bone affected by diseases other than osteoporosis (for example, cancer or Paget's disease). - Satisfactory baseline thoracic and lumbar spinal x-ray views cannot be obtained as determined by the centralized x-ray quality assurance center (for example, severe scoliosis or kyphosis). - Current or recent (within 1 year prior to randomization) metabolic bone disorders other than postmenopausal osteoporosis, such as Paget's disease, renal osteodystrophy, osteomalacia, or any secondary causes of osteoporosis - Current or recent (within 1 year prior to randomization) disease which affects bone metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism. - Currently suspected carcinoma or history of carcinoma in the 5 years prior to randomization. - Nephrolithiasis or urolithiasis in the 2 years prior to randomization. - Current or recent (within 1 year prior to randomization) sprue, inflammatory bowel disease, or malabsorption syndrome, or any indication of poor intestinal absorption of calcium, such as the combination of a low urinary calcium excretion and an elevated serum intact parathyroid hormone level. - Poor medical or psychiatric risk for treatment with an investigational drug, in the opinion of the investigator. - Treatment with androgens or other anabolic steroids in the 6 months prior to randomization. - Treatment with calcitonins in the 2 months prior to randomization. - Treatment with estrogen - Treatment with progestins in the 3 calendar months prior to randomization, or for more than 2 months in the 12 calendar months prior to randomization. - Treatment with corticosteroids. - Treatment with fluorides in the 6 months prior to randomization or for more than 60 days in the 24 months prior to randomization. - Treatment with oral bisphosphonates in the 3 months prior to randomization or for more than 60 days in the 24 months prior to randomization; treatment with intravenous bisphosphonates in the 24 months prior to randomization. - Treatment with vitamin D >50,000 IU/week, or with any dose of calcitriol, analogs, or agonists in the 6 months prior to randomization. The 25-hydroxyvitamin D laboratory value at randomization must be between the lower limit of normal and three times the upper limit of normal. - Treatment with coumarins and indandione derivatives in the 3 months prior to randomization; treatment with heparins >10,000 U/day for more than 30 days in the 6 months prior to randomization. - Treatment with calcium- or aluminum-containing antacids - Treatment with any other drug known to affect bone metabolism in the 6 months prior to randomization. - Treatment with any investigational drug during the month prior to the calcium and vitamin D run-in phase. Treatment with investigational drugs in certain therapeutic classes during the month prior to the calcium & vitamin D run-in phase. | |
| 33 | NCT00251719 | completed | 1 | phase 3 | ['esophagitis, reflux', 'esophagitis, peptic'] | ["['K21.9', 'K21.00', 'K21.01']", "['B37.81', 'K20.0', 'K20.80', 'K20.81', 'K20.90', 'K20.91', 'K21.9']"] | ['dexlansoprazole mr', 'dexlansoprazole mr', 'lansoprazole'] | ['CC1=C(OCC(F)(F)F)C=CN=C1C[S@@](=O)C1=NC2=CC=CC=C2N1', 'CC1=C(OCC(F)(F)F)C=CN=C1C[S@@](=O)C1=NC2=CC=CC=C2N1', 'CC1=C(OCC(F)(F)F)C=CN=C1CS(=O)C1=NC2=CC=CC=C2N1'] | Inclusion Criteria: - Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D). Exclusion Criteria: - Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori. - Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics - Use of antacids [except for study supplied Gelusil®] - Need for continuous anticoagulant therapy (Blood Thinners) - Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus - History of dilatation of esophageal strictures, other than Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter) - Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition - History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer - Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy | |
| 34 | NCT00490919 | completed | 1 | phase 3 | ['low back pain'] | ["['M54.50', 'M54.51', 'M54.59']"] | ['buprenorphine transdermal system', 'placebo'] | ['CO[C@]12CC[C@@]3(C[C@@H]1[C@](C)(O)C(C)(C)C)[C@H]1CC4=C5C(O[C@@H]2[C@@]35CCN1CC1CC1)=C(O)C=C4', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Subjects with moderate to severe chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to screening, - Subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of <5 mg oxycodone (or equivalent) per day, - Subjects whose low back pain is not adequately controlled with non-opioid analgesic medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy Exclusion Criteria: - Subjects who had a surgical procedure directed towards the source of back pain within 6 months of screening or planned during the study conduct period, - Subjects who are allergic to buprenorphine or who had a history of allergies to other opioids, - Subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives. Other protocol-specific inclusion/exclusion criteria may apply. | |
| 35 | NCT00362206 | completed | 1 | phase 3 | ['hyperlipidemia'] | ["['E78.2', 'E78.49', 'E78.5']"] | ['fenofibrate/simvastatin', 'fenofibrate/simvastatin', 'pravastatin'] | ['CC(C)OC(=O)C(C)(C)OC1=CC=C(C=C1)C(=O)C1=CC=C(Cl)C=C1', 'CC(C)OC(=O)C(C)(C)OC1=CC=C(C=C1)C(=O)C1=CC=C(Cl)C=C1', 'CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1'] | Inclusion Criteria: - Mixed dyslipidemia Exclusion Criteria: - Known hypersensitivity to fenofibrates or simvastatin or pravastatin - Pregnant or lactating women - Contra-indication to fenofibrate or simvastatin or pravastatin - Unstable or severe cardiac disease | |
| 36 | NCT00427362 | completed | 1 | phase 3 | ['psoriatic arthritis'] | ["['L40.52']"] | ['adalimumab'] | ['O'] | Inclusion Criteria: - Active psoriatic arthritis defined by >= 3 tender or painful joints and >= 3 swollen joints despite standard psoriatic arthritis therapy - Has had an unsatisfactory response or intolerance to at least two prior or ongoing DMARDs (one of which has to be methotrexate) Exclusion Criteria: - Has a history of cancer or other than certain skin or cervical cancers - Has a history of, or current acute inflammatory joint disease of origin other than PsA, e.g., systemic lupus erythematosus etc. - Has other, unstable diseases, including congestive heart failure, inflammatory bowel disease, recent stroke, leg ulcers or other condition which would put the subject at risk - History of active tuberculosis, history of histoplasmosis or listeriosis - Latent TB or risk factors for the activation of latent TB, e.g. previous exposure to TB, and has not initiated TB prophylaxis prior to the first adalimumab treatment | |
| 37 | NCT01104779 | completed | 1 | phase 3 | ['schizophrenia'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['cariprazine', 'placebo'] | ['CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(CC2)C2=C(Cl)C(Cl)=CC=C2)CC1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | 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) - Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120 - Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 - Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG) Exclusion Criteria: - Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder - Patients in their first episode of psychosis - Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study - Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders - Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study - Substance abuse or dependence within the prior 3 months | |
| 38 | NCT00098124 | completed | 1 | phase 3 | ['fibromyalgia'] | ["['M79.7']"] | ['milnacipran hydrochloride'] | ['CCN(CC)C(=O)C1(CC1CN)C1=CC=CC=C1'] | Inclusion Criteria: - Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria Exclusion Criteria: - Psychiatric illness - Depression - Suicidal risk - Substance abuse - Pulmonary dysfunction - Renal impairment - Active cardiac disease - Liver disease - Autoimmune disease - Cancer - Sleep apnea - Inflammatory bowel disease | |
| 39 | NCT00361504 | completed | 1 | phase 3 | ['osteoarthritis, hip', 'osteoarthritis, knee', 'lower back pain', 'pain'] | ["['M16.9', 'M16.0', 'M16.10', 'M16.11', 'M16.12', 'M16.30', 'M16.31']", "['M17.9', 'M17.0', 'M17.10', 'M17.11', 'M17.12', 'M17.2', 'M17.30']", "['N50.82', 'R07.2', 'R07.82', 'R10.13', 'R10.33', 'R14.1', 'R52']"] | ['oxycodone cr', 'tapentadol (cg5503) er'] | ['[H][C@@]12OC3=C(OC)C=CC4=C3[C@@]11CCN(C)[C@]([H])(C4)[C@]1(O)CCC2=O', 'CC[C@H]([C@@H](C)CN(C)C)C1=CC(O)=CC=C1'] | Inclusion Criteria: - Clinical diagnosis of knee or hip osteoarthritis with history of pain at the reference joint for at least 3 months or clinical diagnosis of low back pain of benign origin for at least 3 months - Must be dissatisfied with their current analgesic therapy (e.g. Non-steroidal anti-inflammatory drugs NSAIDS, COX-2 inhibitors, opioids, paracetamol/acetaminophen - Have a pain intensity >4 on Numerical Rating Scale Exclusion Criteria: - Life-long history of seizure disorder or epilepsy - Any of the following within one year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, and brain neoplasm - Severe traumatic brain injury within 15 years (consisting of more than one of the following: brain contusion (injuries resulting in hemorrhage), intracranial hematoma, unconsciousness or post traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness - History of malignancy within past 2 years, with exception of a successfully treated basal cell carcinoma - Presence of significant pain associated with conditions other than osteoarthritis or low back pain that could confound the assessment or self-evaluation of pain | |
| 40 | NCT00628862 | completed | 1 | phase 3 | ['chronic obstructive pulmonary disease'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['formoterol turbuhaler® 4.5mg', 'formoterol turbuhaler® 9 mg', 'turbuhaler® placebo'] | ['COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1', 'COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms - Current or previous smoker with a smoking history of 10 or more pack years - Lung function parameters: FEV1/FVC < 70%, post-bronchodilator and post-bronchodilator FEV1 < 80% of predicted normal value Exclusion Criteria: - History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis - Use of inhaled glucocorticosteroids within 4 weeks prior to Visit 2 - Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD. | |
| 41 | NCT00413764 | completed | 1 | phase 3 | ['sexual dysfunction'] | ["['R37', 'N53.8', 'N53.9', 'F10.181', 'F10.281', 'F11.181', 'F11.281']"] | ['tibolone', 'estradiol-norethisterone'] | ['[H][C@@]12CC[C@@](O)(C#C)[C@@]1(C)CC[C@]1([H])C3=C(CC(=O)CC3)C[C@@]([H])(C)[C@@]21[H]', '[H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=C(CC[C@@]21[H])C=C(O)C=C3'] | Inclusion Criteria: - Physically and mentally healthy postmenopausal women, >=48 and <=68 years of age, with an intact uterus. - Women were to suffer from decreased satisfactory sexual activity compared to younger age and sexual problems were not to be considered caused by relationship/partner problems. The decreased sexual functioning was to result in sexually related personal distress as confirmed by the FSDS (score =15). - An affirmative answer was to be given to the following questions: (a) In previous years did you find sexual activity satisfying? (b) Has there been a decline in your satisfaction with sexual activity? (c) Are you satisfied with your partner as a friend? - All subjects were to have an established sexual relationship of at least 6 months duration prior to screening. - Women were to be sexually active. - Normal mammography within 6 months prior to randomization. - Body mass index >18 and <=32 kg/m2. - Voluntary written informed consent Exclusion Criteria: - Any unexplained abnormal uterine bleeding - Double layer endometrial thickness >4 mm - Tibolone or transdermal E2/NETA use within 3 months prior to screening - Progestogen implants or injections and estrogen/progestogen injectable therapy within 6 months prior to screening - Use of intra-uterine progestogen - Unsuccessful previous treatment with androgens or compounds known to enhance androgenic activity - Current successful treatment with androgens, without applying the applicable washout period of 3 months prior to screening - Any previous or current unopposed estrogen administration, prior use of estrogen pellets or tamoxifen citrate (previous low dose vaginal estrogen-only applications are allowed) - Use of anti -androgens within the preceding 5 years prior to screening. - Women with significant organic disorder of sexual dysfunction or a partner with sexual dysfunction - Women who had early onset sexual dysfunction (>15 years prior to menopause) - Women suffering from androgenic alopecia, acne or hirsutism - Women suffering from illnesses influencing sexuality - Women using medication influencing sexuality - Moderate to severe depression - Current or prior use of antidepressant within 8 weeks prior to screening - Major gynecological surgery in the preceding 3 months - Any serious disease or disorder; or any endocrine disorder with systemic disease which would have impaired overall health and well being (controlled hypo/hyperthyroidism and diabetes mellitus Type II was allowed) - History or presence of severe psychiatric illness and/or any addictions to drugs, medication or alcohol in the past 3 years - Diseases for which exogenous hormonal steroids were contraindicated. - History or presence of any malignancy, except successfully treated non-melanoma skin cancers - History or presence of cardiovascular or cerebrovascular conditions, thrombosis or thromboembolic disorders - History or presence of liver, gallbladder or renal disease, epilepsy or classical migraine headaches - Uncontrolled hypertension - Women with abnormal cervical smear results - History or presence of breast cancer, suspicious breast lump or mammographic abnormality - Known hypersensitivity to any of the ingredients of the trial medication. - Non-compliance with the screening diary - Current use of raloxifene, clonidine, veralipride, phytoestrogen extracts - Drugs known to interfere with the pharmacokinetics of the steroids - Use of investigational drugs within the past 60 days - Any disease or condition that was clinically relevant and which, in the opinion of the investigator, would have jeopardized the subject's well being during the course of the trial | |
| 42 | NCT00254891 | terminated | see termination reason in detailed description | 0 | phase 3 | ['carcinoma, non-small-cell lung'] | ["['D02.20', 'D02.21', 'D02.22']"] | ['pf-3512676 + paclitaxel + carboplatin', 'paclitaxel + carboplatin'] | ['[H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H]', '[H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H]'] | Inclusion Criteria: - Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV - No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs - Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1 Exclusion Criteria: - Small cell or carcinoid lung cancer - Known Central Nervous System (CNS) metastasis - Pre-existing auto-immune or antibody mediated diseases |
| 43 | NCT00365352 | completed | 1 | phase 3 | ['restless legs syndrome'] | ["['G25.81']"] | ['xp13512 600mg', 'xp13512 1200mg', 'placebo'] | ['CC(C)C(=O)OC(C)OC(=O)NCC1(CC(O)=O)CCCCC1', 'CC(C)C(=O)OC(C)OC(=O)NCC1(CC(O)=O)CCCCC1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Patients with primary RLS, based on the International RLS Study Diagnostic Criteria. Exclusion Criteria: - A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS; - Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias, and dystonias); - Abnormal laboratory results, electrocardiogram (ECG) or physical findings; - Pregnant or lactating women; - Women of childbearing potential who are not practicing an acceptable method of birth control. | |
| 44 | NCT00605280 | completed | 1 | phase 2/phase 3 | ['macular edema associated with diabetes mellitus'] | ["['J95.851', 'D76.2', 'E87.71', 'J65', 'M04.2', 'A80.0', 'G44.82']"] | ['standard of care', 'macugen'] | ['OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12'] | Inclusion Criteria: - macular edema associated with diabetes - visual acuity between 20/50 and 20/200 Exclusion Criteria: - recent laser therapy in the eye - recent signs of uncontrolled diabetes - blood pressure worse than 160/100 - severe cardiac disease | |
| 45 | NCT01355367 | completed | 1 | phase 3 | ['hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['nifedipine (adalat, baya1040)'] | ['COC(=O)C1=C(C)NC(C)=C(C1C1=CC=CC=C1[N+]([O-])=O)C(=O)OC'] | Inclusion Criteria: - Patients who complete the 8 week double blind treatment phase of Study 13176 and for whom the test drug is tolerable Exclusion Criteria: - Patients with expected difficulties for the continuous 1 year follow up | |
| 46 | NCT00415246 | terminated | the preliminary data do not support the expected sustainable blood levels of triptorelin for a duration of 4 months in all patients. | 0 | phase 3 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['triptorelin (decapeptyl®) - treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)'] | ['CC(C)C[C@H](NC(=O)[C@@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=C1C=CC=C2)NC(=O)[C@H](CC1=CNC=N1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1CCC[C@H]1C(=O)NCC(N)=O'] | Inclusion Criteria: - Patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient - Patient must be 18 years old or over - Patient must have a histologically-confirmed diagnosis of locally advanced or metastatic prostate cancer or presenting a relapse after curative treatment which is amenable to androgen deprivation therapy - Patient must have an estimated survival time of greater than 8 months according to the investigator's assessment Exclusion Criteria: - Patient at risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or with significant obstructive uropathy) - Patient who underwent a previous surgical castration - Prostate cancer therapy within 2 months of baseline visit - Patient with testosterone level below 150 ng/dL at screening |
| 47 | NCT00451412 | completed | 1 | phase 3 | ['thromboembolism'] | ["['O88.22', 'O88.23', 'O88.211', 'O88.212', 'O88.213', 'O88.219']"] | ['certoparin', 'unfractionated heparin'] | ['O.O.[Al+3].[Cl-].[Zr+4].NCC([O-])=O'] | Inclusion Criteria: 1. Hospitalized medical patients 70 years of age or older 2. Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances) 3. written informed consent Exclusion Criteria: 1. immobilization longer than 3 days prior to randomization 2. prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system 3. expected major surgical or invasive procedure within the next 3 weeks after randomization 4. LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization 5. immobilization due to cast or fracture 6. indication for anticoagulatory or thrombolytic therapy 7. acute symptomatic DVT / PE 8. known hypersensitivity to any of the study drugs or drugs with similar chemical structures 9. Acute or history of heparin induced thrombocytopenia type II (HIT II) Other protocol-defined inclusion/exclusion criteria may apply | |
| 48 | NCT00289978 | completed | 1 | phase 3 | ['relapsing-remitting multiple sclerosis'] | ["['G35', 'G93.81', 'K74.1', 'Q85.1', 'G12.21', 'G12.23', 'M34.0']"] | ['fingolimod 1.25 mg', 'fingolimod 0.5 mg', 'placebo'] | ['CCCCCCCCC1=CC=C(CCC(N)(CO)CO)C=C1', 'CCCCCCCCC1=CC=C(CCC(N)(CO)CO)C=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis - Patients with a relapsing-remitting disease course - Patients with EDSS score of 0-5.5 Exclusion Criteria: - Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc. - Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria applied to this study. | |
| 49 | NCT00402987 | completed | 1 | phase 3 | ['pharyngitis'] | ["['A54.5', 'J02.0', 'J31.2', 'B08.5', 'J02.9', 'A50.03', 'J02.8']"] | ['celecoxib', 'celecoxib', 'celecoxib', 'placebo'] | ['COC1=CC=C(C=C1)C(=O)CC(=O)C1=CC=C(C=C1)C(C)(C)C', 'COC1=CC=C(C=C1)C(=O)CC(=O)C1=CC=C(C=C1)C(C)(C)C', 'COC1=CC=C(C=C1)C(=O)CC(=O)C1=CC=C(C=C1)C(C)(C)C', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - The patient must have a diagnosis of pharyngitis with objective findings of tonsillo-pharyngitis. - The patient is willing to take "nothing by mouth" including inhaled treatments except trial medication during the two hours while at the site and following trial drug administration (e.g. not smoking, food, drink, candy, lozenges, chewing gum). The patient will be allowed food and drink between hours 2 and 24, but no other oral or inhaled treatments such as smoking, lozenges, chewing gum. After the two hour assessment, the patients will be allowed food and drink within one half-hour following any hourly evaluations sore throat. Exclusion Criteria: - The patient has used any analgesic/antipyretic within 1 dosing interval preceding administration of the first dose of trial medication. - The patient anticipates using any inhaled therapy including beta-agonists (e.g., ventolin) during the 24 hour trial period and, if used, has only used inhaled therapy on an intermittent basis in the week prior to the screening visit. | |
| 50 | NCT01358526 | completed | 1 | phase 3 | ['low back pain'] | ["['M54.50', 'M54.51', 'M54.59']"] | ['oxycodone/naloxone controlled-release', 'placebo'] | ['OC1=CC=C2C[C@H]3N(CC=C)CC[C@@]45[C@@H](OC1=C24)C(=O)CC[C@@]35O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria include: - Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period; - The back pain must be related to nonmalignant and nonneuropathic conditions and without radiation or with only proximal radiation (above the knee); - Subjects must be on opioid analgesic therapy for low back pain which: - Has been ongoing for at least 4 weeks prior to the screening visit and, - Consists of a stable opioid regimen at a total average daily dose equivalent to 20 to 160 mg (inclusive) of morphine for the last 2 weeks prior to the screening visit. Subjects taking tramadol ≥ 100 mg daily on a stable regimen for the last 2 weeks prior to the screening visit will also meet this criterion; - Subjects must require continuation of opioid analgesic treatment in the range of 40 to 160 mg (inclusive) of morphine or its equivalent daily and be likely to benefit from chronic around-the-clock opioid therapy for the duration of the study; - Subjects must have an average pain over the last 14 days score ≥ 5 (on an 11-point numerical rating scale [NRS]) at the screening visit, on their current opioid analgesic medication and, if applicable, nonopioid medication; - Subjects must have an average pain over the last 24 hours score ≥ 5 (on an 11-point NRS) at the screening visit, on their current opioid analgesic medication and, if applicable, nonopioid medication; - Subjects must be willing and able to be compliant with the protocol, capable of subjective evaluation, able to read and understand questionnaires, willing and able to use a diary per protocol, and read, understand, and sign the written informed consent in English. Exclusion Criteria include: - Female subjects who are pregnant (positive serum beta human chorionic gonadotropin [β hCG] test) or lactating; - Subjects with any contraindication or any history of hypersensitivity to oxycodone, naloxone, or other opioids. This does not include subjects who have experienced common opioid side effects (e.g., nausea, constipation); - Subjects with acute spinal cord compression, acute compression fracture, seronegative spondyloarthropathy, acute nerve root compression, cauda equina compression, fibromyalgia, reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), diabetic amyotrophy, meningitis, discitis, or back pain due to secondary infection, tumor, or postherpetic neuralgia; - Subjects with gout, unless controlled on stable suppressive treatment with colchicine or uric-acid-lowering therapy without any attacks for ≥ 2 years and the subject has not been using nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors on a regular basis; - Subjects with pseudogout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or other inflammatory arthritis, or neuropathic pain conditions; - Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study; - Subjects with a history of opioid, alcohol, medication, or illicit drug abuse or addiction; - Subjects who have received any investigational medication within 30 days of first dose of study drug; - Subjects currently taking, or who have taken naloxone, naltrexone, methylnaltrexone, or alvimopan within 10 days before the screening visit; - Subjects who have received study drug in a clinical study of oxycodone/naloxone controlled-release (OXN or ONU). Other protocol specific inclusion/exclusion criteria may apply. | |
| 51 | NCT01412944 | completed | 0 | phase 3 | ['plaque-type psoriasis'] | ["['L40.0', 'L40.4', 'L40.8', 'L40.9', 'L40.1', 'L40.50']"] | ['secukinumab 150mg', 'secukinumab 10mg/kg i.v. regimen'] | ['CCO'] | Inclusion criteria: - Written Informed Consent must be obtained before any assessment is performed, - Subject must be able to understand and communicate with the investigator and comply with the requirements of the study. - Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations. A partial response is defined as having achieved ≥ PASI 50 but < 75 response. Exclusion criteria - Pregnant women or lactating women - Forms of psoriasis other than chronic plaque -type - Ongoing use of prohibited psoriasis treatments - Ongoing use of other non-psoriasis prohibited treatments - Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304 - Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy - UV therapy or excessive exposure to sunlight | |
| 52 | NCT00367237 | completed | 1 | phase 3 | ['arthritis, psoriatic'] | ["['L40.52']"] | ['infliximab + methotrexate (ifx + mtx)', 'methotrexate (mtx)'] | ['CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O', 'CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O'] | Inclusion Criteria: - The subject must meet ALL of the criteria listed below for entry into the study: - Subject must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. - Subject aged 18 years or more, of either sex and any race - Diagnosis of Psoriatic Arthritis with peripheral polyarticular involvement. Patients will have at least one of the following: - Distal Interphalangeal Joints (DIP) involvement - polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis - arthritis mutilans - asymmetric peripheral arthritis - Negative rheumatoid factor - The disease should have been diagnosed at least 3 months prior to screening. - Active disease at the time of screening and prior to receiving the baseline study medication(s) as defined by: - 5 or more swollen joints and - 5 or more tender joints - and one out of the following three categories: - Erythrocyte Sedimentation Rate (ESR) >= 28 mm/h - C-reactive protein (CRP) >= 15 mg/l - Morning stiffness >= 45 min - Subjects must confirm that they are practicing adequate contraception: Female subjects of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptive, and surgical sterilization (e.g., hysterectomy or tubal ligation). - Female subjects of childbearing potential must have a negative pregnancy test at Screening. - Subjects must be eligible for anti-tumor necrosis factor (TNF) treatment according to applicable local guidelines. For all patients chest X-ray and skin test results must be available at baseline. - If using Nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids other than i.v., i.m. or i.a., the patient must be on a stable dose for four weeks prior screening (maximum dose up to 10mg/day of prednisone or its oral equivalent). - The screening laboratory tests must beet the following criteria: - Hemoglobin >= 10 g/dl providing the low hemoglobin level is not due to other diseases than anemia of chronic inflammation. - white blood cell (WBC) >= 3500 / μl - Neutrophils >= 1500 / μl - Platelets >= 100 000/ μl - Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and gamma-glutamyltransferase <= 1.5 x upper limit of normal - Total bilirubin <= 1 x upper limit of normal - Serum creatinine <= 1.5 mg/dl - Patient must be able to adhere to the study visit schedule and other protocol requirements and must have given informed consent prior to any screening procedures. Exclusion Criteria: - The subject will be excluded from entry into the study if ANY of the criteria listed below are met: - Subject is a female who is pregnant, intends to become pregnant during the study (or within 6 months after study completion), or nursing. - Patients with other inflammatory diseases that might interfere with the evaluation of the psoriatic arthritis. - Previous treatment with Infliximab. - Subjects who have previously received MTX or have not discontinued their other DMARD therapy (i.e., sulfasalazine, hydroxychloroquine, leflunomide). - Patients with fibromyalgia syndrome. - Use of cyclosporine or tacrolimus within 4 weeks prior to screening. Use of IM, IV, or IA corticosteroids within 4 weeks prior to screening. - Treatment with any investigational drug within 3 months prior to screening. - Previous treatment with a monoclonal antibody or a fusion protein. - A history of known allergy to murine proteins. - History of infected joint prosthesis within the previous 5 years. - Chronic infections. - History of active tuberculosis requiring treatment within previous 3 years or history of opportunistic infections within 2 months, uncontrolled active infection or documented HIV infection. Also excluded are patients with evidence of latent tuberculosis and patients with old tuberculosis without documented adequate therapy, if they will not be treated according to local tuberculosis (TB) guidelines. - Subject has any clinically significant deviation from normal in the physical examination, chest X-ray, or electrocardiogram (ECG) that, in the investigator's judgment, may interfere with the study evaluation or affect subject safety. - Current signs or symptoms of other severe uncontrolled diseases, which in the investigators opinion would put the patient at an unacceptable risk. - History of lymphoproliferative disease, any current malignancies or history of malignancy within 5 years other than successfully treated basal cell carcinoma or squamous cell carcinoma of the skin. - Subject is part of the staff or a family member of the staff personnel directly involved with this study. - History of drug abuse. - Subjects who are participating in any other clinical study. | |
| 53 | NCT00326053 | completed | 0 | phase 3 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['budesonide/formoterol'] | ['COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1'] | Inclusion Criteria: - 18 - 65 years of age - Presenting at a study emergency department with an asthma exacerbation Exclusion Criteria: - Admission to hospital - Patients receiving more than 2000 µg/day of beclomethasone equivalent inhaled corticosteroids (1000 µg/day fluticasone or 1600 µg/day budesonide) | |
| 54 | NCT00384189 | completed | 1 | phase 3 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['ciclesonide', 'placebo', 'salbutamol'] | ['[H][C@@]12C[C@@]3([H])[C@]4([H])CCC5=CC(=O)C=C[C@]5(C)[C@@]4([H])[C@@H](O)C[C@]3(C)[C@@]1(O[C@@H](O2)C1CCCCC1)C(=O)COC(=O)C(C)C', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CC(C)(C)NCC(O)C1=CC(CO)=C(O)C=C1'] | Main Inclusion Criteria: - History of asthma for at least 6 months - Ability to show optimal use of MDI, including inhalation technique - Lung function and reversibility within specified limits Main Exclusion Criteria: - Concomitant severe diseases - Diseases which are contraindications for the use of inhaled steroids - Two or more inpatient hospitalizations for asthma within the last year - Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study - Use of systemic steroids within the last 30 days prior to inclusion (depot steroids 6 weeks) - Beginning of or change in immunotherapy within the last 6 months prior to inclusion - Inability to follow the procedures of the study | |
| 55 | NCT00311363 | completed | 1 | phase 3 | ['restless legs syndrome'] | ["['G25.81']"] | ['gen (xp13512)', 'gen (xp13512)', 'placebo'] | ['CC(C)C(=O)OC(C)OC(=O)NCC1(CC(O)=O)CCCCC1', 'CC(C)C(=O)OC(C)OC(=O)NCC1(CC(O)=O)CCCCC1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Patients with primary RLS, based on the International RLS Study Group Diagnostic Criteria. Exclusion Criteria: - A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS; - Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's disease, Multiple Sclerosis, dyskinesias, and dystonias); - Abnormal laboratory results, electrocardiogram (ECG) or physical findings; - Pregnant or lactating women; - Women of childbearing potential who are not practicing an acceptable method of birth control. | |
| 56 | NCT01630135 | completed | 1 | phase 3 | ['rhinitis, allergic, perennial'] | ["['J30.0', 'J31.0', 'J30.89', 'J30.9', 'A50.05', 'J30.2', 'J30.1']"] | ['fluticasone furoate', 'placebo'] | ['[H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Informed Consent - 6 to <15 years of age, male or eligible female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control), outpatient - Diagnosis of perennial allergic rhinitis: A positive test response to house dust and/or dust mites on serum antigen-specific IgE antibody test at Visit 1. One year or more clinical history of perennial allergic rhinitis. A positive test result on nasal eosinophil count at Visit 1/1A. - Either subject's parent/guardian who signed ICF or subject is able to complete assessments on the patient diary through the study. - ALT < 2xULN; alkaline phosphatase and bilirubin <= 1.5xULN - Average of 3TNSS is >= 4.0 in the last consecutive 4 days prior to Visit 2. - Completion of the patient diary on >= 3 days of the last consecutive 4 days prior to Visit 2 Exclusion Criteria: - Has a seasonal pollen as an allergen - A nose disorder that could affect the assessment of the study medication or eye or nose surgery (within 3 months prior to Visit 1) - Bacterial or viral infection of upper respiratory tract or eye - Concurrent disease/abnormalities: Clinically significant uncontrolled disease - Known hypersensitivity to corticosteroids or any excipients in the investigational product - Has recent participation in a study and/or exposure to an investigational study drug within 3 months prior to Visit 1 - Use of the following medication and/or its combination drug within the specified time: Anti-IgE (Within 6 months prior to Visit 1), Immunosuppressive medications or Systemic corticosteroids (Within 8 weeks prior to Visit 1), Topical corticosteroids (Within 4 weeks prior to Visit 1), Immunotherapy or nonspecific allassotherapy which was initiated, discontinued or changed its dose within 4 weeks prior to Visit 1 - Affiliation with Investigator's Site: Relative or employee - History of alcohol or drug abuse, children in care or in the opinion of the investigator (sub-investigator), inappropriate to be enrolled in the study. - Average of 3TNSS is >= 8.0 in the last consecutive 4 days prior to Visit 2. - Bacterial or viral infection of upper respiratory tract or eye during the screening period. | |
| 57 | NCT01277523 | completed | 1 | phase 3 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['tiotropium high dose', 'placebo', 'tiotropium low dose'] | ['[H][C@]12O[C@@]1([H])[C@]1([H])C[C@@]([H])(C[C@@]2([H])[N+]1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', '[H][C@]12O[C@@]1([H])[C@]1([H])C[C@@]([H])(C[C@@]2([H])[N+]1(C)C)OC(=O)C(O)(C1=CC=CS1)C1=CC=CS1'] | Inclusion criteria: 1. All patients and their parent(s) (or legally accepted representative) must sign and date respectively an informed assent and an informed consent consistent with International Conference on Harmonisation - Harmonised Tripartite Guideline for Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to the patient's participation in the trial. A separate informed consent/assent is required for pharmacogenomic sampling. 2. Male or female patients between 12 and 17 years of age (at date of informed consent/assent). 3. All patients must have at least a 3-month history of asthma at the time of enrolment into the trial. 4. All patients must have been on maintenance treatment with an inhaled corticosteroid either at stable high dose in combination with another controller medication, OR at stable medium dose in combination with two other controller medications, for at least 4 weeks before Visit 1. 5. All patients must be symptomatic at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of = 1.5. 6. All patients must have a pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) = 60% and = 90% of predicted normal at Visit 1. 7. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator, considered as 100%) as compared to Visit 2 (pre-dose) must be within ± 30%. 8. All patients must confirm the diagnosis of asthma by bronchodilator reversibility at Visit 1, resulting in an increase in FEV1 of = 12% and = 200 mL 15 to 30 minutes after 400 µg salbutamol (albuterol). If patients in the lower age range (e.g. 12 to 14 year old patients) exhibit a very small total lung volume, positive reversibility testing might be based solely on the relative (=12%) post-bronchodilator response. 9. All patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment. 10. Patients must be able to use the Respimat® inhaler correctly. 11. Patients must be able to perform all trial related procedures including technically acceptable spirometric manoeuvres according to American Thoracic Society/ European Respiratory Society (ATS/ERS) standards and use of the electronic diary/peak flow meter (diary compliance of at least 80% is required). Exclusion criteria: 1. Significant disease other than asthma. 2. Abnormal haematology or blood chemistry. 3. History of heart disease, and/or hospitalised for cardiac syncope or failure. 4. Any unstable or life-threatening or requiring intervention or cardiac arrhythmia. 5. Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy. 6. Active tuberculosis. 7. Alcohol or drug abuse. 8. Thoracotomy with pulmonary resection. 9. Pulmonary rehabilitation program. 10. Hypersensitivity to anticholinergic drugs, or any components of the study medication delivery system. 11. Pregnant or nursing adolescent female patients. 12. Female patients of child-bearing potential not using a highly effective method of birth control. 13. Investigational drug within four weeks or six half lives prior to Visit 1. 14. Long-acting anticholinergics within four weeks prior to Visit 1. 15. Systemic corticosteroids at a high dose or at a not stable low dose within four weeks prior to Visit 1. 16. Leukotriene modifiers if not stabilised for at least four weeks prior to Visit 1. 17. Long-acting theophylline preparations if not stabilised for at least two weeks prior to Visit 1. 18. Anti Immunoglobulin E (Anti-IgE) treatment if not stabilised for at least six months prior to Visit 1. 19. Cromones if not stabilised within four weeks prior to Visit 1. 20. Oral beta-blocker medication within four weeks prior to Visit 1. 21. Systemic oral or i.v. or s.c. beta-adrenergics within four weeks prior to Visit 1. 22. Other non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1. 23. Any acute asthma exacerbation or respiratory tract infection in the four weeks prior to Visit 1and/or in the four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed. 24. Randomised in this trial or currently participating in another trial. 25. Narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated. 26. Moderate to severe renal impairment. 27. Patients requiring 10 or more puffs of rescue medication per day on more than 2 consecutive days in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed. | |
| 58 | NCT00395603 | terminated | this study was terminated early due to poor recruitment. | 0 | phase 3 | ['cardiovascular diseases', 'diabetes mellitus'] | ["['A52.00', 'A52.09', 'A50.54', 'Z01.810', 'Q87.418', 'Z13.6', 'R94.30']", "['P70.2', 'O24.92', 'Z83.3', 'E10.65', 'E10.9', 'E11.65', 'E11.9']"] | ['mk0653a, ezetimibe (+) simvastatin / duration of treatment: 6 weeks', 'comparator: atorvastatin / duration of treatment: 6 weeks'] | ['CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1', 'CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1'] | Inclusion Criteria: - Greater than 18 years of age - Treated for at least the last 3 months with a daily dose of atorvastatin 40 mg - Existing coronary heart disease and cholesterol > 4.0 mmol/l Exclusion Criteria: - Uncontrolled diabetes - Elevated liver function tests - Elevated creatine kinase (ck) - Triglycerides (tg) > 4.5 mmol/l - Drug or alcohol dependency within 6 months prior to visit 1 - Woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study - Woman of childbearing potential not using an acceptable method of birth control - Women who are pregnant or breast feeding |
| 59 | NCT00250679 | completed | 1 | phase 3 | ['chronic obstructive pulmonary disease', 'bronchitis', 'emphysema'] | ["['J44.9', 'J44.1', 'J44.0']", "['J20.9', 'J41.0', 'J41.1', 'J42', 'J20.2', 'J20.3', 'J20.6']", "['J43.1', 'J43.2', 'J43.8', 'J43.9', 'J98.2', 'J98.3', 'T79.7XXS']"] | ['arformoterol tartrate inhalation solution', 'arformoterol 25 ųg bid', 'formoterol 12 ųg bid', 'placebo'] | ['COC1=CC=C(C[C@@H](C)NC[C@H](O)C2=CC(NC=O)=C(O)C=C2)C=C1', 'COC1=CC=C(C[C@@H](C)NC[C@H](O)C2=CC(NC=O)=C(O)C=C2)C=C1', 'COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Key Inclusion Criteria: - Male and female subjects must be at least 35 years old at the time of consent - Subjects must have a pre-established, documented primary clinical diagnosis of non-asthmatic COPD or are referred for diagnosis of non-asthmatic COPD - Subjects must have a >=15 pack-year smoking history and a baseline breathlessness severity grade of >=2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Visits 1 and 2 - Female subjects <=65 years of age must have a negative serum pregnancy test, females of childbearing potential must be using an acceptable method of birth control - Subjects must be in general good health. Key Exclusion criteria: - Subjects with a history of asthma, with the exception of asthma diagnosed in childhood - Subjects with a blood eosinophil count >5% of total white blood cell count - Subjects have had a febrile illness within 72 hours (3 days) before Screening Visit 1 - Subjects with a chest x-ray that suggests a diagnosis other than COPD (e.g., diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions) | |
| 60 | NCT00114777 | completed | 1 | phase 3 | ['renal transplantation'] | ["['N25.0', 'Q61.4', 'N23', 'N26.9', 'P96.0', 'Q60.0', 'Q60.1']"] | ['cyclosporin a', 'belatacept less intensive regimen (li)', 'belatacept more intensive regimen (mi)'] | ['CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\\C=C\\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C', 'CCO', 'CCO'] | Inclusion Criteria: - Subject is a first-time recipient of a kidney transplant from a deceased donor. - Specific donor criteria Exclusion Criteria: - Donor age <10 years - Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.) - Subjects with a positive T-cell lymphocytotoxic crossmatch. - Subjects who are positive for Hepatitis B or C, or HIV - Active tuberculosis - History of cancer in the last 5 years - History of substance abuse - Specific laboratory results are exclusionary - Mammography suspicious for cancer - Allergy to iodine - For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156) | |
| 61 | NCT00064623 | completed | 1 | phase 3 | ['hiv infections', 'peripheral nervous system diseases', 'pain'] | ["['Z21']", "['G64', 'M35.06', 'P14.9', 'P14.8', 'C47.9', 'D36.10', 'R94.138']", "['N50.82', 'R07.2', 'R07.82', 'R10.13', 'R10.33', 'R14.1', 'R52']"] | ['capsaicin dermal patch'] | ['COC1=C(O)C=CC(CNC(=O)CCCC\\C=C\\C(C)C)=C1'] | Inclusion Criteria: - At least 18 years of age - Documented evidence of HIV-1 infection - Documented diagnosis of painful HIV-associated distal symmetrical polyneuropathy established by a neurologist resulting from HIV disease and/or antiretroviral drug exposure, with primary symptoms of pain, burning or dysesthetic discomfort in both feet for at least 2 months prior to Screening Visit, and absent or diminished ankle reflexes, and at least one of the following: distal diminution of vibration sensation or pain or temperature sensation in the legs - Either no neurotoxic antiretroviral (didanosine, zalcitabine or stavudine) exposure for at least 8 weeks prior to Screening Visit, or currently on stable dose(s) of any neurotoxic antiretroviral(s) for at least 8 weeks prior to Screening Visit - Screening Pain Sum Score of 12 to 36 - Karnofsky Performance Score of greater than or equal to 60 - Intact, unbroken skin over the painful area(s) to be treated - If taking chronic pain medications, be on a stable (not PRN) regimen for at least 21 days prior to Treatment Visit and willing to maintain these medications at the same stable dose(s) and schedule throughout the study - Female subjects with child-bearing potential: negative serum pregnancy test performed at Screening Visit - Willing to use effective methods of birth control and/or refrain from participating in a conception process during study and for 30 days following experimental drug exposure - Willing and able to comply with protocol requirements for duration of study Exclusion Criteria: - Concomitant opioid medication, unless orally or transdermally administered and not exceeding a total daily dose of morphine 60 mg/day, or equivalent. Parenteral opioid use is excluded, regardless of dose - Unavailability of an effective rescue medication strategy for the subject, such as unwillingness to use opioid analgesics during treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with Roxicodone® or Vicodin®, as judged by the Investigator - Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse judged likely to recur during the study period by the investigator - Recent use (within 21 days preceding the Treatment Visit of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including Lidoderm®), steroids or capsaicin products on the painful areas - Current use of any investigational agent or Class 1 anti-arrhythmic drugs - Significant pain of an etiology other than painful HIV-associated neuropathy; significant ongoing pain from other cause(s) that may interfere with judging HIV-associated neuropathy pain - Evidence of another contributing cause for peripheral neuropathy, e.g., diabetes mellitus requiring medication control (i.e., oral hypoglycemics, insulin); hereditary neuropathy; vitamin B12 deficiency (B12 level ≤ 200 pg/mL) or less than 3 months of B12 supplementation prior to Screening Visit; or treatment within 90 days prior to Screening Visit with any drug that may have contributed to the sensory neuropathy - Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain - Treatment for acute opportunistic infections within 14 days before Treatment Visit - Presence of acute, active opportunistic infection, except oral thrush; oral, genital, or rectal herpes; and Mycobacterium avium bacteremia within 2 weeks prior to Screening Visit - Currently have active malignant disease - Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events - Hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics, Roxicodone®, Vicodin®, or adhesives | |
| 62 | NCT00294541 | terminated | lack of efficacy demonstrated in study ica-17043-10 | 0 | phase 3 | ['sickle cell disease', 'sickle cell anemia'] | ["['D57.1', 'D57.20', 'D57.212', 'D57.219', 'D57.211', 'D57.213', 'D57.218']"] | ['ica-17043'] | ['NC(=O)C(C1=CC=CC=C1)(C1=CC=C(F)C=C1)C1=CC=C(F)C=C1'] | Inclusion Criteria: - Successfully completed Study ICA-17043-10 - Discontinued Study 10 or 12 following the DMC recommendations because he/she was not on HU, and has since been on a stable dose of HU for at least 3 months prior to Day 1 - Male, or female not capable of becoming pregnant or using appropriate birth control - Has willingly given written informed consent to participate in this study Exclusion Criteria: - The subject, if female, has a positive urine pregnancy test on Day 1 (before entering study) - The subject is presently unsuitable for participation in this long-term study |
| 63 | NCT01114737 | completed | 1 | phase 3 | ['phenylketonuria'] | ["['E70.0']"] | ['sapropterin dihydrochloride', 'placebo'] | ['[H][C@@]1(CNC2=C(N1)C(=O)NC(N)=N2)[C@@H](O)[C@H](C)O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - ≥ 8 years of age - Confirmed diagnosis of PKU - Willing to continue current diet (typical diet for the 3 months prior to study entry) unchanged while participating in the study - Willing and able to provide written, signed informed consent or in the case of subjects under the age of 18, provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures - Sexually active subjects must be willing to use an acceptable method of contraception while participating in the study and for at least 30 days following the last dose of sapropterin dihydrochloride - Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study. Females considered not of childbearing potential include those who have been in menopause at least 2 years, or had tubal ligation at least 1 year prior to screening, or have had total hysterectomy. - Willing and able to comply with all study procedure Exclusion Criteria: - Has known hypersensitivity to sapropterin dihydrochloride or its excipients - Subject breastfeeding at screening or planning to become pregnant (subject or partner) at any time during the study - Use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to the completion of all scheduled study assessments - Received sapropterin dihydrochloride within 16 weeks of randomization - Have initiated or adjusted medication for treatment of ADHD, depression, or anxiety ≤ 8 weeks prior to randomization - Taking medication known to inhibit folate synthesis (eg, methotrexate) - Any condition requiring treatment with levodopa or any PDE-5 inhibitor - Concurrent disease or condition that would interfere with study participation, compliance or safety as determined by the Investigator - Any condition that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study | |
| 64 | NCT00004031 | completed | 1 | phase 3 | ['lymphoma'] | ["['S33.110S', 'S33.111S', 'S33.120S', 'S33.121S', 'S33.130S', 'S33.131S', 'S33.140S']"] | ['chop regimen', 'carmustine', 'cyclophosphamide', 'doxorubicin hydrochloride', 'etoposide', 'prednisone', 'vincristine sulfate'] | ['CCO', 'ClCCNC(=O)N(CCCl)N=O', 'ClCCN(CCCl)P1(=O)NCCCO1', 'COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1', '[H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C', 'CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1'] | DISEASE CHARACTERISTICS: - Histologically proven intermediate- or high-grade non-Hodgkin's lymphoma - Ann Arbor classification of "bulky" stage II, III, or IV - Must be classified as high-intermediate or high-risk according to International Age Adjusted Index - Bidimensionally measurable disease - No lymphoblastic, transformed, or mantle cell lymphomas - No CNS involvement by lymphoma - CD20 status confirmed by immunocytochemistry or flow cytometry - Must have either bilateral or unilateral bone marrow aspiration and biopsy ≥ 42 days before first course of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy (or CHOP plus rituximab [CHOP-R] for CD20+ disease) OR within 42 days prior to registration if CHOP/CHOP-R therapy has not begun - Must have bilateral bone marrow aspiration and biopsy within 28 days of randomization - Bone marrow involvement with lymphoma is allowed, provided there is an improvement of at least 50% if used as an evaluable site of disease - No prior lymphoma, Hodgkin's lymphoma, myelodysplastic syndromes, or leukemia NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: - 15 to 65 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - No nonlymphoma-related hepatic dysfunction Renal: - Creatinine no greater than 2 times ULN - Creatinine clearance at least 60 mL/min - No nonlymphoma-related renal dysfunction - No history of grade 3 hemorrhagic cystitis due to cyclophosphamide Cardiovascular: - No coronary artery disease, cardiomyopathy, congestive heart failure, or dysrhythmia requiring therapy - MUGA scan or 2-D echocardiogram required if patient's history is questionable - Ejection fraction normal Pulmonary: - DLCO or FEV_1 at least 60% of predicted Other: - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative - No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No allergy to etoposide - No active bacterial, fungal, or viral infection PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior monoclonal antibody therapy for lymphoma except if included in a single course of CHOP/CHOP-R Chemotherapy: - No prior chemotherapy for lymphoma except for a single course of CHOP/CHOP-R* NOTE: *Prednisone or other corticosteroids not considered prior chemotherapy Endocrine therapy: - See Chemotherapy - Prior corticosteroids allowed Radiotherapy: - No prior radiotherapy for lymphoma - No prior thoracic radiotherapy or radiotherapy greater than 2,000 cGy to any other site Surgery: - Not specified | |
| 65 | NCT00387348 | terminated | dsmb stopped study because placebo arm had more adverse events | 0 | phase 3 | ['colorectal cancer', 'depression', 'esophageal cancer', 'extrahepatic bile duct cancer', 'fatigue', 'gallbladder cancer', 'gastric cancer', 'liver cancer', 'lung cancer', 'pancreatic cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['F32.A', 'F53.0', 'P91.4', 'Z13.31', 'Z13.32']", "['K22.2', 'K22.81', 'Q39.4', 'P78.83', 'I85.00', 'I85.01', 'I85.10']", "['C24.0', 'D13.5']", "['R53.83', 'G93.3', 'R53.82', 'R53.0', 'T67.6XXS', 'T67.6XXA', 'T67.6XXD']", "['C23', 'D37.6']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']", "['D13.4', 'Z85.05', 'C22.8', 'C78.7', 'C22.9', 'D37.6']", "['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']", "['C25.3']"] | ['escitalopram oxalate', 'placebo'] | ['CN(C)CCC[C@]1(OCC2=C1C=CC(=C2)C#N)C1=CC=C(F)C=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | DISEASE CHARACTERISTICS: - Diagnosis of any of the following for at least 4 weeks: - Stage IIIB (with effusions) or stage IV non-small cell lung cancer - Extensive stage small cell lung cancer - Stage III or IV pancreatic cancer - Stage IV liver cancer - Stage III or IV gallbladder cancer - Stage III or IV bile duct cancer - Stage IV esophageal cancer - Stage IV gastric cancer - Second line stage IV colorectal cancer - Meets diagnostic and Statistical Manual of Mental Disorders-4th Edition and Endicott criteria for major depressive disorder - Duration of depressive symptoms ≥ 4 weeks - Hamilton Depression D 17 (HAM-D 17) Scale ≥ 14 - No active suicidality requiring immediate care or psychiatric hospitalization PATIENT CHARACTERISTICS: - Able to swallow pills - No active substance abuse disorder (including alcohol abuse within the past 6 months), psychotic disorder or active psychotic symptoms, organic mental disorders, or bipolar disorder - No clinical or laboratory evidence of hypothyroidism - No hypercalcemia - No severe anemia, defined as hemoglobin < 10 g/dL - No history of multiple adverse drug reactions or allergy to study drugs - Not pregnant - No history of head trauma - No history of epilepsy PRIOR CONCURRENT THERAPY: - No other concurrent antidepressant medications or psychostimulants |
| 66 | NCT00585208 | terminated | sponsor terminated study | 0 | phase 3 | ['insomnia', 'bipolar disorder'] | ["['F51.01', 'F51.02', 'F51.03', 'F51.04', 'G47.00', 'G47.09', 'A81.83']", "['F31.81', 'F31.89', 'F31.9', 'F25.0', 'F31.0', 'F31.31', 'F31.32']"] | ['ramelteon', 'placebo'] | ['CCC(=O)NCC[C@@H]1CCC2=C1C1=C(OCC1)C=C2', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: 1. Subjects must be 18 to 65 years of age, inclusive. 2. Subjects must have lifetime bipolar I disorder as defined by DSM-IV-TR criteria. 3. Subjects' manic symptoms must be mild to moderate in severity, defined as an YMRS score between 10 and 25. 4. Subjects must be currently experiencing a clinically significant sleep disturbance, defined as a PSQI total score > 5. 5. Subjects must be receiving at least 1 mood stabilizing medication, which may include an atypical antipsychotic (e.g., aripiprazole, clozapine, olanzapine, quetiapine, risperidone, ziprasidone) and/or mood stabilizer/anticonvulsant (e.g, lithium, carbamazepine, valproate/divalproex, lamotrigine, oxcarbazepine) medication for > 1 week prior to baseline. Continued administration of benzodiazepines or sedative-hypnotics will be allowed only if the subject has been receiving the medication for > 2 weeks prior to baseline. 6. Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained. 7. If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least 1 month prior to study entry and throughout the study. Exclusion Criteria: 1. Subjects who are experiencing clinically significant suicidal or homicidal ideation. 2. Subjects who are currently experiencing psychotic symptoms. 3. Subjects with a current DSM-IV-TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV-TR diagnosis of a substance dependence disorder within the past 6 months; or, a lifetime DSM-IV-TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder). 4. Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the investigator. 5. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement for > 3 months. 6. Subjects with a clinically significant abnormality in their pre-study physical exam, vital signs, EKG, or laboratory studies. 7. Subjects who are allergic to or who have demonstrated hypersensitivity to ramelteon. 8. Subjects who are taking medications that interact with ramelteon (e.g., ketoconazole, fluconazole, fluvoxamine, rifampin). 9. Females who are pregnant or nursing. 10. Subjects who have received an experimental drug or used an experimental device within 30 days. |
| 67 | NCT01670032 | completed | 0 | phase 2/phase 3 | ['impetigo'] | ["['L01.00', 'L01.02', 'L01.03', 'L01.09', 'L01.01']"] | ['experimental: cd07223 1.5 % topical gel bid', 'experimental: cd07223 1.5% topical gel tid', 'placebo comparator: cd07223 vehicle gel bid', 'placebo comparator: cd07223 vehicle gel tid'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Male or female 2 years of age or older - Clinical diagnosis of primary impetigo (bullous or non bullous) - Minimum diameter of Target Lesion to be one centimeter measured either as length or width. - Presence of at least one and no more than ten lesions per subject at the time of screening - The infected lesions' total area (as determined by the Investigator) must be less than 100 cm2 in total area for subjects 18 years of age or older, or up to a maximum of 2% total body surface area for subjects younger than 18 years of age. - Skin Infection Rating Scale (SIRS) total score of the Target Lesion of at least 4 Exclusion Criteria: - Presence of other active skin diseases at or near the Target Lesion area to be treated - A subject whose disease is so widespread or severe that, in the opinion of the investigator, oral antibiotic treatment is needed - Signs and symptoms of another current infection requiring antibiotic treatment - Tympanic temperature at Screening/Baseline exceeding 38 degrees Celsius (100.4 degrees Fahrenheit) in a pediatric subject or 37.8 degrees Celsius (100 degrees Fahrenheit) in an adult subject - History of Hepatitis B or C, HIV/ AIDS, or other immunodeficiency disease - Concurrent or recent scabies infection or lice infestation (pediculosis) of the scalp - Use of systemic antibiotics or systemic steroids within 14 days prior to study entry. A history of three or more courses of systemic antibiotics within the 3 month period immediately prior to screening will also be considered exclusionary - Use of topical antibiotics, topical antibacterials, topical antifungals or topical steroids within 14 days prior to study entry on any skin lesion (as deemed significant by the Investigator by virtue of the lesion's nature and/or position to impact on the effectiveness of the study drug) - Participation in any other clinical study or use of any investigational drugs or investigational device within 30 days prior to enrollment - Presence of secondarily infected traumatic lesions (e.g. surgical wounds, animal/insect bites, burns, lacerations and abrasions). - Another family member in same household currently enrolled in this study or another family member in the same household with active impetigo | |
| 68 | NCT00621842 | completed | 1 | phase 3 | ['bipolar disorder', 'depression, bipolar'] | ["['F31.81', 'F31.89', 'F31.9', 'F25.0', 'F31.0', 'F31.31', 'F31.32']", "['F32.A', 'F53.0', 'P91.4', 'Z13.31', 'Z13.32']"] | ['lamotrigine regular tablet formulation', 'lamotrigine novel formulation'] | ['NC1=NC(N)=C(N=N1)C1=C(Cl)C(Cl)=CC=C1', 'NC1=NC(N)=C(N=N1)C1=C(Cl)C(Cl)=CC=C1'] | Inclusion Criteria: - Age 60 Years or older - BP Disorder-I or II: Depressive episode (DSM -IV-TR; SCID-I/P) - HAM-D score > 18 (GRID-HAM-D 24-item version) - Availability of an Informant is encouraged but not required for study participation Exclusion Criteria: - Chronic psychotic conditions, ie. schizophrenia, schizoaffective disorder, delusional disorder - Contraindication to lamotrigine (Physician interview, medical assessment) - Documented history of intolerance to lamotrigine - Patients who have previously failed to respond to at least 12 weeks of treatment with lamotrigine - Active substance dependence (SCID-I/P) or substance-related safety issues or PI concerns - Mood Disorder Due to a General Medical Condition or Treatment (Physician interview) - Rapid cycling (Physician interview): As defined in DSM-IV: At least 4 episodes of mood disturbance in the previous 12 months that meet criteria for a Major Depressive, Manic, Mixed or Hypomanic Episode. Episodes are distinguished either by partial or full remission for at least 2 months or by a switch to an episode of opposite polarity - Dementia (by DSM-IV or brain degenerative diseases; Physician interview); - Inability to communicate in English (i.e., interview cannot be conducted without an interpreter; subject largely unable to understand questions and cannot respond in English) - Clinically significant sensory impairment (i.e., cannot see well enough to read consent or visually-presented material; cannot hear well enough to cooperate with interview; Physician interview) - Recent history of cardiovascular, peripheral vascular events or stroke - High risk for suicide (e.g., active SI or current intent or plan) - Inpatient status | |
| 69 | NCT00397631 | completed | 1 | phase 3 | ['type 2 diabetes mellitus'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['sitagliptin 100 mg q.d./pioglitazone 30 mg q.d', 'comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.'] | ['N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | General Inclusion Criteria: - Patients ≥18 years old with Type 2 Diabetes Mellitus (a specific type of diabetes) General Exclusion Criteria: - Patient has a history of type 1 diabetes mellitus or history of ketoacidosis - Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 4 months - Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 2 years | |
| 70 | NCT00427219 | completed | 0 | phase 2/phase 3 | ['benign prostatic hypertrophy'] | ["['J35.3', 'J35.1', 'J35.2', 'N28.81', 'N62', 'N85.2', 'J34.3']"] | ['ozarelix/placebo', 'placebo'] | ['CCCC[C@H](NC(=O)[C@@H](CCCCNC(N)=O)NC(=O)[C@H](CC1=CC=C(O)C=C1)N(C)C(=O)[C@H](CO)NC(=O)[C@@H](CC1=CC=CN=C1)NC(=O)[C@@H](CC1=CC=C(Cl)C=C1)NC(=O)[C@@H](CC1=CC=C2C=CC=CC2=C1)NC(C)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - All of the following questions must be answered "Yes" at Visit 1 in order for the patient to participate in the study. - Is the patient at least 50 years old? - Does the patient have clinical signs and symptoms consistent with BPH? - Does the patient have an IPSS ³13 at screening (prior to placebo run in)? - Does the patient have a peak urinary flow rate (Qmax) of 4-15 mL/sec established on a voided volume of at least 125 mL? - Is the patient willing to agree not to use any other approved or experimental pharmacologic BPH treatments including alpha blockers, 5-alpha reductase inhibitors, anti-cholinergic preparations or herbal preparations at any time during the study? Exclusion Criteria: All of the following questions must be answered "No" at Visit 1 in order for the patient to participate in the study. - Does the patient have a history of prostate cancer or a serum PSA >10 ng/mL? - Has the patient had prior prostate or bladder surgery, pelvic surgery (excluding hernia repair), pelvic radiation or lower urinary tract malignancy? - Does the patient have a prevoid total bladder volume assessed by ultrasound > 550 mL? - Does the patient have a residual urine volume > 350 mL by ultrasound? - Has the patient taken or is currently taking any of the following: | |
| 71 | NCT01075282 | completed | 1 | phase 3 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['insulin glargine', 'ly2189265', 'metformin', 'glimepiride'] | ['[Na+].[Na+].[O-]P([O-])(F)=O', 'CSCC[C@H](N)C(O)=O', '[H][C@]1(C)CC[C@@]([H])(CC1)N=C(O)NS(=O)(=O)C1=CC=C(CCN=C(O)N2CC(C)=C(CC)C2=O)C=C1'] | Inclusion Criteria: - Type 2 Diabetes not well controlled on 1, 2, or 3 oral antidiabetic medications (at least one of them must be metformin and/or a sulfonylurea) 1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication 2. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications - Accept treatment with metformin and glimepiride throughout the study, as per protocol - Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for Insulin Glargine. - Stable weight for 3 months prior to screening - Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2) - Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug Exclusion Criteria: - Type 1 Diabetes - HbA1c equal to or less than 6.5 at randomization - Chronic insulin use - Taking drugs to promote weight loss by prescription or over the counter - Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled - History of Heart Failure New York Heart Classification III or IV, or acute myocardial infarction, or stroke within 2 months of screening - Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility - Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper normal limit - Acute or chronic pancreatitis of any form - Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatinine clearance of less than 60 milliliters per minute (ml/min) - History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer - A serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/ml) at screening - Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis - History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years - Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing - Organ transplant except cornea - Have enrolled in another clinical trial within the last 30 days - Have previously signed an informed consent or participated in a LY2189265 study - Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening | |
| 72 | 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)'] | ['CC1=CC(O)=CC(C)=C1Cl'] | 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. | |
| 73 | NCT00334282 | completed | 1 | phase 3 | ['carcinoma, renal cell'] | ["['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']"] | ['pazopanib', 'placebo'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: A patient will be considered for inclusion in this study only if all of the following criteria apply: - Signed written informed consent. - Diagnosis of clear cell RCC that is predominantly clear cell histology. Note: cytology cannot be the only pathologic criteria to confirm clear cell RCC. Patients with tumor types that are interpreted as non-clear cell, e.g. papillary, are excluded. - Locally advanced RCC (defined as disease not amenable to curative surgery or radiation therapy) or metastatic RCC (equivalent to Stage IV RCC according to American Joint Committee on Cancer (AJCC) staging. - Note: If the metastatic disease is restricted to a solitary lesion, its neoplastic nature must be confirmed by histology or cytology. Cytology cannot be the only pathologic criteria to confirm clear cell RCC, but can be used in a patient with histologically confirmed clear cell RCC to confirm that metastatic disease is neoplastic in nature. - Must have measurable disease, i.e. presenting with at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST). A measurable lesion is defined as a lesion that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques, or ≥ 10 mm with spiral CT scan. - Note: Patient should be excluded if all baseline measurable lesions are within previously irradiated areas. - Note: A patient must complete all the baseline disease assessments in order to be eligible. Baseline head, chest, abdominal and pelvic CT or MRI scans must be performed within 2 weeks prior to the first dose of study medication; baseline bone scan must be performed within 3 weeks of the first dose of study medication. - Patients who have received only one prior systemic treatment for locally advanced or metastatic RCC with documented disease progression or documented treatment discontinuation due to unacceptable toxicity. This first-line systemic treatment must be cytokine based. - Note: The first-line cytokine-based treatment can be interleukin-2 (IL-2) or interferon-α (INFα) monotherapy, IL-2 in combination with INF-α, IL-2 and/or INF-α in combination with chemotherapy, hormonal or other therapies excluding agents targeting angiogenesis pathways. Agents in a combination regimen can be given sequentially if the treatment sequence is pre-determined and the patient does not fail one agent prior to starting another. - Note: Prior adjuvant or neo-adjuvant therapies are permitted excluding any agents that target vascular endothelial growth factor (VEGF) or VEGF receptors. The adjuvant/neo-adjuvant therapies should not be considered as first-line systemic treatment for advanced RCC. Or, - Patients who have received no prior systemic therapy for advanced/metastatic RCC can be enrolled if under any of the following circumstances: - Patients who live in countries or regions where there is no established standard first-line therapy for advanced/metastatic RCC or where there are barriers to the access of established therapies such as sunitinib, sorafenib, IFNα or IL-2. - Patients who live in countries or regions where IL-2 or INF-α has been approved for the treatment of advanced/metastatic RCC, however, these agents are generally not recognized by the local clinical community as a standard treatment for advanced/metastatic RCC, or where the physician and the patient have determined that the available cytokine therapies are not an acceptable therapeutic option. - Patients who have recurred following prior adjuvant or neo-adjuvant cytokine therapy for RCC are eligible to participate without receiving a first-line systemic treatment for locally advanced or metastatic RCC. These patients should be stratified as the first-line population. - Male or female ≥ 18 years of age. - A woman is eligible to participate in the study if she is of: - Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who: - Has had a hysterectomy, - Has had a bilateral oophorectomy (ovariectomy), - Has had a bilateral tubal ligation, - Is post-menopausal (total cessation of menses for ≥1 year). - Childbearing potential, has a negative serum pregnancy test within 2 weeks of the first dose of study medication, and agrees to use adequate contraception. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows: - An intrauterine device with a documented failure rate of less than 1% per year. - Vasectomized partner who is sterile prior to the female patient's entry and is the sole sexual partner for that female. - Complete abstinence from sexual intercourse for 14 days before exposure to investigation product, through the clinical trial, and for at least 21 days after the last dose of investigational product. - Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide). - Oral contraceptives are not reliable due to the potential for drug-drug interactions. - A man with a female partner of childbearing potential is eligible to enter and participate in the study if he is abstinent or uses a barrier method of contraception during the study. - Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1 - Adequate baseline organ function defined as: - Hematologic function: Absolute Neutrophil Count (ANC) ≥1 x 10^9/L Hemoglobin ≥ 9 g/dL Platelet ≥75 x 10^9/L - Hepatic function: Total bilirubin ≥ 1.5 x Upper Limit of Normal (ULN) Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≥ 2 x ULN - Renal function: Calculated creatinine clearance≥30 mL/min [See Section 14.6 Appendix 6] and ≥Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram determined by 24-hour urine protein analysis. - Note: A patient should first be screened with dipstick urinalysis. If urine protein is ≥2+, then a 24-hour urine protein must be assessed and patient will be excluded if 24-hour urine protein is≥ 1.0 gram. - Corrected serum calcium level within normal range per local clinical laboratory standard. Note: Patients with hypercalcemia should be treated until the corrected serum calcium level reaches the normal range. - At least 4 weeks must have elapsed since the last surgery and 2 weeks must have elapsed since radiotherapy or the last systemic cytokine therapy. - Complete recovery from prior surgery, and/or reduction of all AEs to Grade 1 from prior systemic therapy or radiotherapy. - Note: In patients with prior radiotherapy, the steroid doses should be stable or decreasing for at least 2 weeks. Exclusion Criteria: A patient will not be eligible for inclusion in this study if any of the following criteria apply: - Pregnant or lactating female. - History of another malignancy. - Note: Patients who have had another malignancy and have been disease-free for 5 years, or patients with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible. - History or presence of central nervous system (CNS) metastasis or leptomeningeal tumors as documented by CT or MRI scan, analysis of cerebrospinal fluid or neurological exam. Note: A baseline brain CT or MRI scan must be obtained in all patients within 2 weeks of the first dose of study medication. - Malabsorption syndrome or disease that significantly affects gastrointestinal function, or major resection of the stomach or small bowel that could affect the absorption of pazopanib. - Unable to swallow and retain orally administered medication. - Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning study treatment. - History of human immunodeficiency virus infection. - Presence of uncontrolled infection. - Corrected QT interval (QTc) prolongation defined as QTc interval > 470 msecs. - History of Class III or IV congestive heart failure according to New York Heart Association (NYHA) classification. - History of any one of the following cardiac conditions within the past 6 months: - Cardiac angioplasty or stenting, or - Myocardial infarction, or - Unstable angina. - History of cerebrovascular accident within the past 6 months. - Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140mmHg, or diastolic blood pressure (DBP) of ≥ 90mmHg]. - Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. The blood pressure must be re-assessed on two occasions that are separated by a minimum of 24 hours. The mean SBP / DBP values from both blood pressure assessments must be < 140/90mmHg in order for a patient to be eligible for the study. - History of untreated deep venous thrombosis (DVT) within the past 6 months (e.g. a calf vein thrombosis that is not treated). Note: Patients with recent DVT who are treated with therapeutic anti-coagulating agents (excluding therapeutic warfarin) for at least 2 weeks are eligible. - Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease. - Evidence of bleeding diathesis or coagulopathy. - Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study. - Has taken any prohibited medications within 14 days of the first dose of study medication. - Current or prior use of an investigational anti-cancer drug within 4 weeks of start of study. - Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors (eg. bevacizumab, sunitinib, sorafenib, etc). | |
| 74 | NCT01500083 | completed | 1 | phase 3 | ["indolent non-hodgkin's lymphoma", 'chronic lymphocytic leukemia'] | ["['C91.11', 'C91.12', 'C91.10']"] | ['bendamustine at a dose of 100 mg/m2', 'bendamustine at a dose of 120 mg/m2'] | ['CN1C(CCCC(O)=O)=NC2=CC(=CC=C12)N(CCCl)CCCl', 'CN1C(CCCC(O)=O)=NC2=CC(=CC=C12)N(CCCl)CCCl'] | Inclusion Criteria for iNHL: - The patient has biopsy-confirmed diagnosis of indolent B-cell NHL documented as relapsed or refractory iNHL (following rituximab-based therapy). - The patient has one of the following types of indolent B-cell lymphoma: - follicular lymphoma grade 1, 2, or 3A - marginal zone lymphoma - lymphoplasmacytic lymphoma - small lymphocytic lymphoma - The patient has adequate haematologic function (unless abnormalities are related to lymphoma involvement of the bone marrow or hypersplenism caused by lymphoma). Inclusion Criteria for CLL: - The patient has previously confirmed (according to WHO criteria) untreated symptomatic chronic B-cell lymphocytic leukemia Binet Stage B or Binet Stage C or Rai stage II to IV in need of medical treatment. - The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Exclusion Criteria: - The patient has participated in a clinical study <30 days prior to the Screening Visit. - The patient has one or more of the following conditions: - active transformed lymphoma - any history of central nervous system or leptomeningeal lymphoma - an active malignancy other than the target cancer within the past 5 years - human immunodeficiency virus - The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason. Other inclusion and exclusion criteria may apply. | |
| 75 | NCT00631319 | completed | 0 | phase 3 | ['chronic pain'] | ["['G89.29', 'G89.4', 'R39.82', 'G89.22', 'G89.28', 'G89.21', 'G89.3']"] | ['oros hydromorphone', 'placebo'] | ['[H][C@@]12OC3=C(O)C=CC4=C3[C@@]11CCN(C)[C@]([H])(C4)[C@]1([H])CCC2=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria - Primary clinic diagnosis of osteoarthritis pain of the hip or of the knee for at least 6 months - Patients required daily opioid medication to treat their chronic osteoarthritis pain Exclusion Criteria - Joint replacement of the hip or of the knee that is the primary source of osteoarthritis Pain - History drug or alcohol abuse - Fibromyalgia - Patients who have major depression or anxiety - Women who are pregnant or breast feeding | |
| 76 | NCT00062673 | completed | 1 | phase 3 | ['depression', 'cognition'] | ["['F32.A', 'F53.0', 'P91.4', 'Z13.31', 'Z13.32']"] | ['duloxetine', 'placebo'] | ['CN(C)CCC[C@]1(OCC2=C1C=CC(=C2)C#N)C1=CC=C(F)C=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - You must be able to visit the doctor's office for clinic visits, tests, and procedures. - You must have been diagnosed with major depression, and have had at least one other episode in the past. Exclusion Criteria: - You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder. - You have taken a drug within the last 30 days that has not been approved for use by governmental authorities. | |
| 77 | NCT01094964 | unknown status | 0 | phase 3 | ['bladder cancer'] | ["['D30.3', 'C67.5', 'C67.9', 'C79.11', 'C67.0', 'C67.1', 'D41.4']"] | ['epirubicin hydrochloride', 'mitomycin c'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'CO[C@]12[C@H]3N[C@H]3CN1C1=C([C@H]2COC(N)=O)C(=O)C(N)=C(C)C1=O'] | DISEASE CHARACTERISTICS: - Diagnosis of non-muscle invasive bladder cancer - Recurrent disease after undergoing induction or maintenance therapy with bacillus Calmette-Guérin (BCG), meeting any 1 of the following criteria: - Stage Ta or T1 disease (grade 2 or 3) - Carcinoma in situ with stage Ta or T1 disease (grade 1, 2, or 3) - Carcinoma in situ alone - Has undergone a second resection of all T1 disease to exclude muscle invasive disease - No urothelial cell carcinoma (UCC) ≥ T2 - No recurrence of grade 1 UCC following BCG induction therapy - No UCC involving the prostatic urethra or upper urinary tract PATIENT CHARACTERISTICS: - WHO performance status 0-4 - WBC ≥ 3.0 x 10^9/L - Absolute neutrophil count ≥ 1.5 x 10^9/L - Hemoglobin ≥ 10 g/dL - Platelet count ≥ 100 x 10^9/L - Serum creatinine < 1.5 times upper limit of normal - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Normal kidneys and ureters on imaging CT scan within the past 12 months - Available for long-term follow-up with a life expectancy of the duration of the trial - Must be fit and willing to undergo a full or partial cystectomy - No known or suspected reduced bladder capacity (< 250 mL) - No significant bleeding disorder - No other malignancy within the past 5 years except nonmelanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix, or DCIS/LCIS of the breast - No known allergy to mitomycin or bacillus Calmette-Guérin (BCG), or previously withdrawn from BCG treatment due to a related adverse event (e.g., systemic infection) - No active or intractable urinary tract infection - No urethral stricture or any situation impeding the insertion of a 20F catheter - No bladder diverticula > 1 cm - No significant urinary incontinence - No concurrent implanted electronic devices (e.g., cardiac pacemakers) or metallic implants within the pelvis, lower torso, spine, hip, or upper femur - No immunocompromised state for any reason PRIOR CONCURRENT THERAPY: - At least 6 months since prior intravesical chemotherapy, except for single instillation post-transurethral resection - No prior pelvic irradiation - No prior hyperthermia in combination with intravesical mitomycin - Concurrent participation in other studies allowed - No current or long-term use of corticosteroids - No concurrent chemotherapy | |
| 78 | NCT00306540 | completed | 1 | phase 3 | ['post-traumatic stress disorder'] | ["['F43.10', 'F43.11', 'F43.12']"] | ['quetiapine fumarate', 'quetiapine fumarate placebo'] | ['OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12', 'OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12'] | Inclusion Criteria: - Hospitalised and non-hospitalised patients / Veteran or Civilian / Have had symptoms of PTSD for a minimum of 12 months prior to giving consent to the study Exclusion Criteria: - History of psychotic condition / quetiapine or other anti-psychotics not worked previously / Taking prohibited medications (mood stabilizers / substance abuse) | |
| 79 | NCT01294215 | completed | 1 | phase 3 | ['hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['nifedipine (adalat, baya1040)'] | ['COC(=O)C1=C(C)NC(C)=C(C1C1=CC=CC=C1[N+]([O-])=O)C(=O)OC'] | Inclusion Criteria: - 20 years or older - Japanese male or female - Outpatient with essential hypertension - Patients who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study Exclusion Criteria: - Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg or more - Patients with secondary hypertension or hypertensive emergency | |
| 80 | NCT00453063 | completed | 0 | phase 3 | ['seasonal allergic rhinitis'] | ["['J30.2']"] | ['mometasone furoate', 'placebo'] | ['[H][C@@]12C[C@@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Must be 12 years of age or older, of either sex and of any race. - Must have at least a 2-year documented history of SAR which exacerbates during the study season. - Must have a positive skin-prick test response to an appropriate seasonal allergen at Screening (Visit 1). Immunoglobulin E (IgE)-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes. - Must be clinically symptomatic at the Screening Visit. - Must be clinically symptomatic at the Baseline Visit. - Must be in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram (ECG) results. Clinical laboratory test (complete blood count [CBC], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor. - Must be free of any clinically significant disease, other than SAR, that would interfere with the study evaluations. Exclusion Criteria: - A history of anaphylaxis and/or other severe local reaction(s) to skin testing. - A subject with asthma who requires chronic use of inhaled or systemic corticosteroids. - Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip. - A subject with rhinitis medicamentosa. - A history of allergies to more than two classes of medications or who are allergic to or cannot tolerate nasal sprays. - A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days before the Screening Visit. - A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow. - A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids. | |
| 81 | NCT00329238 | completed | 1 | phase 3 | ['thromboembolism'] | ["['O88.22', 'O88.23', 'O88.211', 'O88.212', 'O88.213', 'O88.219']"] | ['dabigatran', 'warfarin'] | ['CCCCCCOC(=O)\\N=C(\\N)C1=CC=C(NCC2=NC3=C(C=CC(=C3)C(=O)N(CCC(=O)OCC)C3=NC=CC=C3)N2C)C=C1', 'S1SSSSSSS1'] | Inclusion criteria: Inclusion_Criteria - Acute symptomatic deep vein thrombosis (DVT) - Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing Exclusion criteria: Exclusion_Criteria - Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE. - Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) > 2x ULN - Severe renal impairment (estimated creatinine clearance <= 30 ml/min) | |
| 82 | NCT00544076 | terminated | accrual too slow | 0 | phase 3 | ['prostate cancer', 'male erectile disorder', 'stage i prostate cancer', 'stage ii prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']", "['F52.21']", "['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']", "['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['sildenafil citrate', 'alprostadil'] | ['CCCC1=NN(C)C2=C1NC(=NC2=O)C1=C(OCC)C=CC(=C1)S(=O)(=O)N1CCN(C)CC1', 'CCCCC[C@H](O)\\C=C\\[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(O)=O'] | Inclusion Criteria - All patients undergoing BNS-RAP for prostate cancer will be asked to participate - Ability to achieve erections sufficient for intercourse prior to surgery and an SHIMS-5 score of >= 22 - Must maintain follow up care at COH for visits 1, 3, 6, 9, 12, and 18 months post surgery - Participants willing to participate on study for a minimum of 18 months - Consented participant on the Prostate database study (protocol 00149) - Patients must have a clinical stage of < T3 - Gleason score < 8 on post-operative pathological sample prior to randomization Exclusion Criteria - Metastatic disease - Coronary artery disease on nitrate therapy (including oral sublingual nitrates) - Unable to maintain follow up visits at COH at 1, 3, 6, 9, 12, and 18 months post-operatively - Pathology diagnosis >= pT3 - Prior hormonal treatment use for prostate cancer or low serum testosterone - Allergy to prostaglandin PGE1, Lidocaine, or Viagra - Gleason score >= 8 on post-operative pathological sample prior to randomization - Concomitant use of cytochrome P450 3AY inhibitors (cimetidine, erythromycin, ketoconazole, or protease inhibitors) - SHIMS-5 score =< 21 |
| 83 | NCT00504062 | completed | 1 | phase 3 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['budesonide', 'fluticasone'] | ['COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1', '[H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C'] | Inclusion Criteria: - Provision of signed written informed consent by patient's legal representative; when possible a signed written informed consent should be obtained from the patient themselves - Patients diagnosed as having bronchial asthma regardless of type of asthma i.e. perennial or seasonal, atopic or non-atopic - Males/females 5-15 yrs old who are able to experience to inhale with turbuhaler and diskus. the investigator will check whether the patient can inhale appropriately using training devises and "Turbuhaler trainer" - Patients with bronchial asthma who require treatment with inhaled steroids (patients with drug therapy, in whom asthma is poorly controlled) - Patients who are already treated with inhaled GCS should have at least 3 months prehistory of asthma before obtaining the written informed consent Exclusion Criteria: - Use of regular(more than 3 days) systemic (oral, intravenous or intramuscular) steroids within 30 days before the observation period - The daily dose of inhaled GCS within 30 days before the observation period for the patients who are already treated with inhaled GCS is beyond fluticasone propionate (FP) 200 µg/day or beclomethasone dipropionate (BDP) 200 μg/day. - Respiratory infections that, in the opinion of the investigator(s), may affect the efficacy evaluation e.g. lower airways infection such as pneumonia, infection with no available effective antimicrobial drugs or with deep seated mycosis within 30 days before the observation period. - Concurrent serious diseases of liver, kidney, heart or other complications which, in the opinion of the investigator(s), may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study - Contra-indications (e.g., known or suspected allergy) to budesonide, fluticasone or lactose contained in the investigational product - Participation in another clinical study within 12 weeks prior to the observation period or during the study - Previous enrolment in the present study - Current use of budesonide turbuhaler - Pregnancy or possible pregnancy, or planning to be pregnant during the study period - Patients whose legal representative/caregiver is involved in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site) - Other subjects who are considered inappropriate to participate in this study as judged by the investigator | |
| 84 | NCT00607373 | completed | 1 | phase 3 | ['lipid metabolism, inborn errors', 'hypercholesterolemia, autosomal dominant', 'hyperlipidemias', 'metabolic diseases', 'hyperlipoproteinemia type ii', 'metabolism, inborn errors', 'genetic diseases, inborn', 'infant, newborn, diseases', 'metabolic disorder', 'congenital abnormalities', 'hypercholesterolemia', 'hyperlipoproteinemias', 'dyslipidemias', 'lipid metabolism disorders'] | ["['E70.5', 'E71.32', 'E72.4', 'E76.9', 'E78.89', 'E83.2', 'E88.40']", "['E78.01', 'E78.00', 'Z83.42']", "['Z86.39', 'O99.280', 'O99.281', 'O99.282', 'O99.283', 'O99.284', 'O99.285']", "['E71.42', 'P09.1']", "['E88.9', 'O03.33', 'O04.83', 'O03.83', 'O07.33', 'E88.89', 'E89.89']", "['Z36.83', 'Z82.79']", "['E78.01', 'E78.00', 'Z83.42']", "['Z83.438']"] | ['mipomersen', 'placebo'] | ['[H]C1(CC([H])(OP(O)(=S)OCC2([H])OC([H])(CC2([H])OP(O)(=S)OCC2([H])OC([H])(CC2([H])OP(O)(=S)OCC2([H])OC([H])(CC2([H])OP(O)(=S)OCC2([H])OC([H])(CC2([H])OP(O)(=S)OCC2([H])OC([H])(CC2([H])OP(O)(=S)OCC2([H])OC([H])(CC2([H])OP(O)(=S)OCC2([H])OC([H])(CC2([H])OP(O)(=S)OCC2([H])OC([H])(CC2([H])OP(O)(=S)OCC2([H])OC([H])(N3C=NC4=C3NC(=N)N=C4O)C([H])(OCCOC)C2([H])OP(O)(=S)OCC2([H])OC([H])(N3C=C(C)C(=N)N=C3O)C([H])(OCCOC)C2([H])OP(O)(=S)OCC2([H])OC([H])(N3C=NC4=C(N)N=CN=C34)C([H])(OCCOC)C2([H])OP(O)(=S)OCC2([H])OC([H])(N3C=C(C)C(=N)N=C3O)C([H])(OCCOC)C2([H])OP(O)(=S)OCC2([H])OC([H])(N3C=C(C)C(=N)N=C3O)C([H])(OCCOC)C2([H])O)N2C=C(C)C(=N)N=C2O)N2C=C(C)C(O)=NC2=O)N2C=C(C)C(O)=NC2=O)N2C=C(C)C(=N)N=C2O)N2C=NC3=C2NC(=N)N=C3O)N2C=C(C)C(O)=NC2=O)N2C=C(C)C(=N)N=C2O)N2C=C(C)C(O)=NC2=O)C([H])(COP(O)(=S)OC2([H])CC([H])(OC2([H])COP(O)(=S)OC2([H])C([H])(COP(O)(=S)OC3([H])C([H])(COP(O)(=S)OC4([H])C([H])(COP(O)(=S)OC5([H])C([H])(COP(O)(=S)OC6([H])C([H])(CO)OC([H])(N7C=NC8=C7NC(=N)N=C8O)C6([H])OCCOC)OC([H])(N6C=C(C)C(=N)N=C6O)C5([H])OCCOC)OC([H])(N5C=C(C)C(=N)N=C5O)C4([H])OCCOC)OC([H])(N4C=C(C)C(O)=NC4=O)C3([H])OCCOC)OC([H])(N3C=C(C)C(=N)N=C3O)C2([H])OCCOC)N2C=NC3=C(N)N=CN=C23)O1)N1C=NC2=C1NC(=N)N=C2O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) - Stable lipid-lowering therapy for 12 weeks - Stable weight for 6 weeks - Stable low fat diet for 8 weeks Exclusion Criteria: - Significant health problems in the recent past including heart attack, stroke, blood disorders, cancer, or digestive problems | |
| 85 | NCT00110214 | completed | 0 | phase 3 | ['adenocarcinoma of the prostate', 'hormone-resistant prostate cancer', 'recurrent prostate cancer', 'stage iv prostate cancer'] | ["['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']", "['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']", "['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']", "['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['docetaxel', 'prednisone'] | ['[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', '[H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C'] | Inclusion Criteria: - Patients must have histologically documented adenocarcinoma of the prostate with progressive systemic (clinically metastatic disease documented on bone, CT or MRI scan) disease despite castrate levels of testosterone due to orchiectomy or LHRH agonist; castrate levels of testosterone must be maintained - All eligible patients must have a Gleason sum based on biopsy or TURP at the time of registration - At the time of enrollment, patients must have evidence of progressive metastatic disease, either: - Measurable disease with any level of serum PSA OR - Non-measurable disease with PSA ≥ 5 ng/ml; patients with PSA ≥ 5 ng/ml only and no other radiographic evidence of metastatic prostate cancer are not eligible - Definition of Measurable Disease/Target Lesions: - Any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques: 1) physical exam for clinically palpable lymph nodes and superficial skin lesions, 2) chest X-ray for clearly defined lung lesions surrounded by aerated lung OR those lesions measured as ≥ 10 mm with a spiral CT or MRI scan - Measurable lesions (up to a maximum of 10 in number) representative of all organs involved to be identified as target lesions; the sum of the longest diameters (LD) for all target lesions will be calculated and reported as baseline sum LD - If measurable disease is confined to a solitary lesion and is not consistent with prostate cancer, then its neoplastic nature must be confirmed by histology - Ultrasound may not be used to measure tumor lesions that are not easily accessible clinically - Definition of Non-measurable Disease/Non-target Lesions: - Non-target lesions include all other lesions not included in above, including small lesions with longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan and truly non-measurable lesions, which include: - Bone lesions - Pleural or pericardial effusions, ascites - CNS lesions, leptomeningeal disease - Irradiated lesions, unless progression documented after RT - Patients must have demonstrated evidence of progressive disease since the most recent change in therapy; progressive disease is defined as any one of the following (measurable disease, bone scan, or PSA progression): - Measurable Disease Progression: Objective evidence of increase > 20% in the sum of the longest diameters (LD) of target lesions from the time of maximal regression or the appearance of one or more new lesions - Bone Scan Progression: Appearance of one or more new lesions on bone scan attributable to prostate cancer along with a PSA ≥ 5 ng/ml will constitute progression - PSA Progression: An elevated PSA (≥ 5 ng/mL) which has risen serially on at least two occasions after the discontinuation of antiandrogen therapy, each at least one week apart; if the confirmatory PSA (#3) value is less than screening PSA (#2) value, then an additional test for rising PSA (#4) will be required to document progression - The reference PSA value (#1) must be measured at the time of the discontinuation of antiandrogen therapy; and at least 2 PSA measurements must be made following the end of antiandrogen therapy and prior to registration - (For the purposes of the nomogram calculator, the last PSA value recorded prior to the initiation of treatment will be considered the baseline PSA) - Progression despite standard androgen deprivation therapy (i.e., LHRH agonist and/or orchiectomy) - All antiandrogens (e.g., flutamide, megestrol acetate [even if taken for hot flashes], bicalutamide and nilutamide) of any dose must be discontinued at least 4 weeks prior to registration; if improvement following antiandrogen withdrawal is noted, progression must be established using the criteria above - Primary testicular androgen suppression (e.g., with an LHRH agonist) should not be discontinued - At least 4 weeks since any other hormonal therapy, including ketoconazole and aminoglutethimide; the only exception to this time frame is that 5α-reductase inhibitors (e.g., finasteride, dutasteride) may be discontinued any time prior to registration - No prior cytotoxic chemotherapy, including estramustine or suramin - No prior anti-angiogenesis agents, including thalidomide and bevacizumab - ≥ 4 weeks since major surgery and fully recovered - ≥ 4 weeks since any prior radiation (including palliative) and fully recovered - ≥ 8 weeks since the last dose of Strontium-89 or Samarium - Patients receiving a bisphosphonate must be on a stable dose and must have started the bisphosphonate ≥ 4 weeks prior to initiating protocol treatment. Patients do not have to be on a bisphosphonate to qualify for the study; patients may initiate bisphosphonate therapy after completion of Cycle 1, if clinically indicated - Patients enrolled on CALGB 90202 who have documented disease progression and have received at least 4 weeks of open label zoledronic acid treatment, are eligible for this study. - No known brain metastases (brain imaging (MRI/CT) is not required) - No current congestive heart failure (New York Heart Association Class II, III or IV) - Patients with history of hypertension must be well controlled (< 160/90) on a regimen of anti-hypertensive therapy - Patients on full-dose anticoagulants must be on a stable dose of warfarin and have an in-range INR (usually between 2 and 3) or be on a stable dose of LMW heparin; patients receiving anti-platelet agents are also eligible; in addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible - No significant history of bleeding events or GI perforation - Patients with a history of significant bleeding episodes (e.g., hemoptysis, upper or lower GI bleeding) within 6 months of registration are not eligible - Patients with a history of GI perforation within 12 months of registration are not eligible. - No recent (within 12 months) arterial thrombotic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina or angina requiring surgical or medical intervention in the past 12 months, or myocardial infarction (MI); patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) or any other arterial thrombotic event are also ineligible - No serious or non-healing wound, ulcer or bone fracture - No peripheral neuropathy ≥ grade 2 - Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies are not eligible - PC-Spes, Saw Palmetto, and St. John's Wort must be discontinued before registration; the discontinuation of other herbal medications and food supplements is strongly encouraged; patients may continue on daily vitamins and calcium supplements - ECOG performance status: 0-2 - ANC ≥ 1500/μL - Platelet count ≥ 100,000/μL - Creatinine ≤ 1.5 x upper limits of normal - Bilirubin ≤ 1.5 x upper limits of normal - For patients with Gilbert's Disease, ≤ 2.5 X ULN is allowed - AST ≤ 1.5 x upper limits of normal - PSA ≥ 5 ng/mL (if non-measurable disease) - Urine protein to creatinine ratio < 1.0 | |
| 86 | NCT00314977 | completed | 0 | phase 3 | ['breast cancer'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['doxorubicin', 'cyclophosphamide', 'docetaxel'] | ['COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O', 'ClCCN(CCCl)P1(=O)NCCCO1', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: - Women presenting with large resectable or locally advanced breast cancer (T2 ≥3 cm, T3, or T4, and/or LN positive) - Measurable disease (breast and/or lymph nodes) - No prior surgery other than biopsy and no prior chemotherapy or radiation therapy - Age ≥18 years and age ≤70 years - Karnofsky Performance score ≥70% - Estrogen and/or progesterone receptor analysis performed on the primary tumour in the biopsy material - In case the tumor is ER/PgR ³ 50% positive, (neo)adjuvant hormonal therapy in stead of chemotherapy should be considered (e.g. in TEAM II study) - Her2/neu receptor analysis performed on the primary tumour in the biopsy material - Adequate bone marrow function (within 14 days prior to registration): WBC ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l - Adequate liver function (within 4 weeks prior to start treatment): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL - Adequate renal function (within 4 weeks prior to start treatment): the calculated creatinine clearance should be ≥50 mL/min - Patients must be accessible for treatment and follow-up - Written informed consent according to the local Ethics Committee requirements Exclusion Criteria: - Patients with advanced pulmonary disease of any cause (oxygen dependent)- Peripheral neuropathy > grade 2 whatever the cause - Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrythmias - Evidence of distant metastases (M1) - Patients with a history of breast cancer - Patients with a history of another malignancy (except basal cell skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry- Pregnant or lactating women, or potentially fertile women not using adequate contraception | |
| 87 | NCT00206141 | completed | 1 | phase 3 | ['bipolar disorder', 'bipolar depression', 'depression'] | ["['F31.81', 'F31.89', 'F31.9', 'F25.0', 'F31.0', 'F31.31', 'F31.32']", "['F32.A', 'F53.0', 'P91.4', 'Z13.31', 'Z13.32']", "['F32.A', 'F53.0', 'P91.4', 'Z13.31', 'Z13.32']"] | ['quetiapine fumarate (seroquel™) drug, mood stabilizer (mood)'] | ['OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12'] | Inclusion Criteria: - Patients with a diagnosis of bipolar I disorder or bipolar II disorder, currently depressed, aged 18 to 65 years old and outpatient status at enrolment and randomization. Exclusion Criteria: - Patients with a current DSM-IV Axis I disorder other than bipolar disorder that is symptomatic or requiring treatment within 6 months of enrolment, - History of non-response to an adequate treatment - Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk - Pregnancy or lactation - Clinically relevant disease or clinical finding | |
| 88 | NCT00474786 | completed | 0 | phase 3 | ['renal cell carcinoma'] | ["['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']"] | ['sorafenib', 'temsirolimus (torisel)'] | ['CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1', 'OCC(C)(CO)C(=O)O[C@@H]1CC[C@@H](C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\\C=C(C)\\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\\C=C\\C=C\\C=C(C)\\[C@@H](OC)C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@H]3C(=O)O2)C[C@H]1OC'] | Inclusion Criteria: - Histologically confirmed diagnosis of mRCC (regardless of histology or nephrectomy status) with well-documented Radiological PD by RECIST criteria or clinical PD as judged by the investigator while receiving first-line sunitinib therapy. Subjects must have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously). - At time of randomization, at least 2 weeks since prior treatment with sunitinib, palliative radiation therapy, and/or surgery. - At time of randomization, there must be at least 1 measurable lesion per RECIST. Lesions that have been previously irradiated or embolized cannot be selected as target lesions. - More criteria apply Exclusion Criteria: - Metastatic CNS from RCC. - Subjects who discontinued Sutent therapy due specifically to intolerance. - Prior systemic therapy for mRCC other than sunitinib. - Active ketonuria, secondary to poorly controlled diabetes mellitus - More criteria apply | |
| 89 | NCT00262769 | completed | 1 | phase 3 | ['extrahepatic bile duct cancer', 'gallbladder cancer'] | ["['C24.0', 'D13.5']", "['C23', 'D37.6']"] | ['cisplatin', 'gemcitabine hydrochloride'] | ['[H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC', 'NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F'] | DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed biliary tract, gallbladder, or ampullary carcinoma - Intra- or extra-hepatic disease allowed - Unresectable locally advanced, recurrent, or metastatic disease - No brain metastases PATIENT CHARACTERISTICS: Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 10 g/dL (transfusion allowed) - WBC ≥ 3,000/mm^3 Hepatic - AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) - Bilirubin ≤ 1.5 times ULN - Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present) - Adequate biliary drainage - No unresolved biliary tract obstruction Renal - Creatinine < 1.5 times ULN - Urea < 1.5 times ULN - Glomerular filtration rate (GFR) ≥ 45 mL/min - If GFR < 60 mL/min, isotope EDTA confirmation of adequate renal function is required Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - No active, uncontrolled infection - No other severe or uncontrolled systemic disease - No other malignancy within the past 5 years except nonmetastatic basal cell or squamous cell skin cancer or carcinoma in situ of the cervix treated by cone-biopsy or resection - No psychiatric disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Chemotherapy - At least 6 months since prior adjuvant chemotherapy - No prior gemcitabine hydrochloride - No prior cisplatin - No prior systemic chemotherapy for locally advanced or metastatic disease except low-dose radiosensitizing chemotherapy in conjunction with radiotherapy Radiotherapy - Prior radiotherapy for localized disease allowed provided there is clear evidence of disease progression afterwards Surgery - Prior curative surgery allowed provided there is evidence of nonresectable disease relapse requiring systemic chemotherapy Other - Recovered from all prior therapies - Prior photodynamic therapy (PDT) allowed provided it was given for localized disease only (with no evidence of metastatic disease) and resulted in subsequent disease progression after completion of therapy OR to relieve biliary obstruction in the presence of metastatic disease - PDT must have been completed ≥ 4 weeks ago - At least 4 weeks since prior investigational agents - No other concurrent, curative anticancer therapy | |
| 90 | NCT01143090 | completed | 1 | phase 3 | ['schizophrenia', 'schizoaffective disorder'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']", "['F25.9', 'F25.0', 'F25.1', 'F25.8']"] | ['lurasidone hcl'] | ['CO[C@H]1\\C=C\\O[C@@]2(C)OC3=C(C2=O)C2=C(O)C(\\C=N\\N4CCN(C)CC4)=C(NC(=O)\\C(C)=C/C=C/[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@@H](C)[C@H](OC(C)=O)[C@@H]1C)C(O)=C2C(O)=C3C'] | Inclusion Criteria: - Subject has completed 6 weeks of treatment and all required assessments on the final study visit (Visit 8) of Study D1050289 (NCT01143077). Exclusion Criteria: - Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or damage to property. - Subject has a body mass index (BMI) greater than 40 or less than 18 kg/m2 (see Appendix 3 for BMI determination). | |
| 91 | NCT00035048 | completed | 0 | phase 3 | ['major depressive disorder'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['aprepitant', 'comparator: placebo (unspecified)'] | ['[H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Patients with Major Depressive Disorder | |
| 92 | NCT00103168 | completed | 0 | phase 3 | ['gastrointestinal stromal tumor'] | ["['C49.A0', 'C49.A1', 'C49.A2', 'C49.A5', 'C49.A3', 'C49.A4', 'C49.A9']"] | ['imatinib mesylate'] | ['CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1'] | DISEASE CHARACTERISTICS: - Histologically confirmed gastrointestinal stromal tumor - Localized disease - Meets 1 of the following criteria: - At high-risk of relapse, defined by 1 of the following criteria: - Tumor size > 10 cm - Mitotic rate > 10/50 high-power field (HPF) - Tumor size > 5 cm AND mitotic rate > 5/50 HPF - At intermediate-risk of relapse, defined by 1 of the following criteria: - Tumor size < 5 cm AND mitotic rate 6-10/50 HPF - Tumor size 5-10 cm AND mitotic rate < 5/50 HPF - Tumor must stain positive for Kit (CD117) by polyclonal DAKO antibody staining - Must have undergone complete resection of the primary tumor at least 2 weeks, but no more than 3 months, before study entry - Meets criteria for 1 of the following resection levels: - R0 (clear margins) - R1, defined by 1 of the following criteria: - Margins of resection are contaminated by tumor, but no macroscopic tumor is left behind - Intraoperative tumor rupture - Shelling-out procedure - Endoscopic maneuver - No residual macroscopic disease after surgery - Regional positive lymph nodes allowed provided they have been macroscopically excised - No distant metastases*, including any of the following: - Peritoneal lesion not contiguous to the primary tumor - Liver metastases - Hemoperitoneal metastases NOTE: *Even if a complete resection (R0) was performed PATIENT CHARACTERISTICS: Age - 18 and over Performance status - WHO 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9 g/dL (transfusions allowed) Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST or ALT ≤ 2.5 times ULN - No uncontrolled liver disease - No chronic viral hepatitis at risk of reactivation Renal - Creatinine < 1.5 times ULN - No uncontrolled chronic renal disease Cardiovascular - No New York Heart Association class III-IV cardiac disease - No congestive heart failure - No myocardial infarction within the past 2 months Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for up to 3 months after study participation - No uncontrolled diabetes - No uncontrolled active infection - No HIV infection - No psychological, familial, sociological, or geographical condition that would preclude study compliance or participation - No other severe and/or uncontrolled medical disease - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - No other prior molecular targeted or biologic therapy - No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) to support blood counts - No concurrent anticancer biologic agents Chemotherapy - No prior chemotherapy for gastrointestinal stromal tumors - No concurrent anticancer chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy - No concurrent anticancer radiotherapy Surgery - See Disease Characteristics - Prior non-curative surgery allowed (e.g., surgery with main diagnostic intent or emergency surgery with symptomatic intent) Other - No prior imatinib mesylate - No prior randomization to this study - No concurrent therapeutic anticoagulation with coumarin derivatives - Concurrent therapeutic low-molecular weight heparin or mini-dose coumarin derivatives (equivalent to oral warfarin 1 mg/day) allowed for prophylaxis of central venous catheter thrombosis - No other concurrent antitumoral therapy - No other concurrent anticancer agents - No other concurrent investigational drugs | |
| 93 | NCT00443690 | completed | 0 | phase 3 | ['heart failure, congestive'] | ["['I50.20', 'I50.21', 'I50.22', 'I50.30', 'I50.31', 'I50.32', 'I50.40']"] | ['rolofylline', 'comparator: placebo (unspecified)'] | ['CCCN1C2=C(NC(=N2)C23C[C@@H]4CC2C[C@H](C3)C4)C(=O)N(CCC)C1=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Dyspnea at rest or with minimal exertion at randomization - Fluid overload - Estimated creatinine clearance (CrCl) between 20-60 mL/min - Worsening renal function - Anticipated need for IV diuretic treatment for at least 48 hours after the start of study drug - BNP >500 pg/mL or NT-pro-BNP >2000 pg/mL - Systolic blood pressure ≥90 mmHg at randomization Exclusion Criteria: - IV radiographic contrast within 14 days - IV vasodilators within 6 hours - Serum potassium <3.5 meq/L - Ongoing or planned therapy for heart failure with mechanical circulatory or ventilatory support - Ongoing or planned treatment with ultrafiltration, hemofiltration, or dialysis - Rapidly progressive acute renal failure - Evidence of acute tubular necrosis or post-obstructive nephropathy or other exogenous causes of acute kidney injury, unrelated to heart failure - Severe pulmonary disease - Significant stenotic mitral or aortic valvular disease - Heart transplant recipient or admitted for cardiac transplantation or LVAD surgery - Any major surgery within 2 weeks prior - evidence of acute coronary syndrome in the 2 weeks prior - Hgb <8 g/dL, Hct <25%, or active bleeding requiring transfusion - Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy. - Known hepatic impairment - Non-cardiac pulmonary edema - Temperature >38°C - Sepsis or active infection requiring IV anti-microbial treatment - Administration of an investigational drug or device within 30 days - Current or anticipated therapy with atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole - Administration of any vasopressor or inotropic drug within 72 hours - History of seizure (except febrile seizure) - Stroke within 2 years - History of brain tumor of any etiology - Brain surgery within 2 years - Encephalitis/meningitis within 2 years - History of penetrating head trauma - Closed head injury with loss of consciousness (LOC) over 30 minutes within 2 years - History of or at risk for alcohol withdrawal seizures - Advanced Alzheimer's disease - Advanced multiple sclerosis | |
| 94 | NCT01229813 | completed | 0 | phase 3 | ['colorectal cancer'] | ["['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['bevacizumab, erlotinib', 'bevacizumab', 'bevacizumab', 'low dose capecitabine'] | ['COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1', 'CCCCCOC(=O)NC1=NC(=O)N(C=C1F)[C@@H]1O[C@H](C)[C@@H](O)[C@H]1O'] | Inclusion Criteria: - Untreated metastatic colorectal carcinoma - Age 18 yrs or over - Measurable disease according to Response Evaluation Criteria in solid Tumors (RECIST criteria) - ECOG performance status 0 or 1 - Life expectancy more than 3 months - Adequate haematological, renal and liver function - Tumor tissue available for determination of KRAS mutational status - Blood sample and paraffin embedded tumor tissue for translational research Exclusion Criteria: - Adjuvant therapy within 6 months - CNS metastases - Clinically significant atherosclerotic vascular disease | |
| 95 | NCT00729183 | completed | 1 | phase 3 | ['osteoporosis'] | ["['M81.6', 'Z82.62', 'Z13.820', 'M81.8', 'Z87.310', 'M81.0', 'M80.80XS']"] | ['odanacatib', 'placebo', 'vitamin d3', 'calcium supplement'] | ['CC(C)(F)C[C@H](N[C@@H](C1=CC=C(C=C1)C1=CC=C(C=C1)S(C)(=O)=O)C(F)(F)F)C(=O)NC1(CC1)C#N', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'CC(C)CCC[C@@H](C)[C@@]1([H])CC[C@@]2([H])\\C(CCC[C@]12C)=C\\C=C1\\C[C@@H](O)CCC1=C', '[Ca++].[Ca++].[Ca++].OC(CC([O-])=O)(CC([O-])=O)C([O-])=O.OC(CC([O-])=O)(CC([O-])=O)C([O-])=O'] | Inclusion Criteria: - Participant has been postmenopausal for 3 years - Participant has BMD t-score at the total hip, hip trochanter, femoral neck, or lumbar spine ≥ -1.5 but > -3.5 - Participant has 2 hips that are evaluable by dual-energy X-ray absorptiometry (DXA) and quantitative computed tomography (QCT), e.g. contain no hardware from orthopedic procedures - Participant is ambulatory Exclusion Criteria: - Participant has had a previous hip fracture - Participant has had >1 prior clinical vertebral fracture AND is a candidate for osteoporosis therapy - Participant has been treated with oral bisphosphonates, strontium, parathyroid hormone (PTH) or other agents with an effect on bone - Participant has had metabolic bone disorder other than osteoporosis - Participant has renal stones, Parkinson's disease, multiple sclerosis (MS) or active parathyroid disease. | |
| 96 | NCT00097825 | completed | 1 | phase 3 | ['osteoporosis'] | ["['M81.6', 'Z82.62', 'Z13.820', 'M81.8', 'Z87.310', 'M81.0', 'M80.80XS']"] | ['zoledronic acid'] | ['OC(CN1C=CN=C1)(P(O)(O)=O)P(O)(O)=O'] | Inclusion Criteria: - Male, 25-85 years old Exclusion Criteria: - Current users of bisphosphonates such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel ® (residronate), Skelid® (tiludronate) - History of severe liver, kidney or eye disease Other protocol-defined inclusion/exclusion criteria may apply. | |
| 97 | NCT01227265 | completed | 0 | phase 3 | ['parkinson disease', 'idiopathic parkinson disease', "idiopathic parkinson's disease"] | ["['G20']", "['E20.0', 'I95.0', 'L50.1', 'D61.3', 'G24.2', 'G24.4', 'G60.3']", "['G20']"] | ['preladenant', 'placebo'] | ['COCCOC1=CC=C(C=C1)N1CCN(CCN2N=CC3=C2N=C(N)N2N=C(N=C32)C2=CC=CO2)CC1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Each participant must have a diagnosis of idiopathic Parkinson's disease. - Each participant must have received prior therapy with L-dopa for approximately 1 or more years immediately before Screening and must continue to have a beneficial clinical response to L-dopa. - Each participant must have been on a stable dopaminergic treatment regimen for at least the 5 weeks immediately before Randomization. Participants receiving other adjunctive treatments (eg, dopamine agonist, anticholinergics) are permitted to enroll in this trial. Participants taking only L-dopa are permitted to enroll in this trial. - Each participant must be experiencing motor fluctuations with or without dyskinesias within the 4 weeks immediately before Screening, must be experiencing a minimum of 2 hours/day of "off" time, and have a Hoehn & Yahr stage between 2.5 and 4 when in the "on" state. - Each participant, with or without the help of a caregiver, must be capable of maintaining an accurate and complete symptom diary and to adhere to dose and visit schedules. - Each participant must have results of Screening clinical laboratory tests drawn within 5 weeks prior to Randomization clinically acceptable to the investigator and not within the parameters specified for exclusion (below). - All participants who are sexually active or plan to be sexually active agree to use a highly effective method of birth control while in the study and for 2 weeks after the last dose of study drug. A male participant must also not donate sperm within 2 weeks after the last dose of study drug. Exclusion Criteria: - A participant must not have a form of drug induced or atypical parkinsonism, a cognitive impairment, bipolar disorder, untreated major depressive disorder, schizophrenia, or other psychotic disorder; history exposure to a known neurotoxin, or any neurological features not consistent with the diagnosis of PD as assessed by the investigator. - A participant must not have a history of repeated strokes or head injuries, or a stroke within 6 months of Screening; poorly controlled diabetes; abnormal renal function; or a severe or ongoing unstable medical condition. - A participant must not have had surgery for their PD. - A participant must not be at imminent risk of self-harm or harm to others. - A participant must not have a systolic blood pressure (BP) ≥150 mm Hg OR diastolic BP ≥95 mm Hg at Screening and at 2 BP rechecks prior to study start. - A participant must not have had any clinically significant cardiovascular event or procedure for 6 months prior to study start, including, but not limited to, myocardial infarction, angioplasty, unstable angina, or heart failure; and a participant must not have heart failure staged New York Heart Association Class III or IV. - A participant must not have an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 x the upper limit of normal (ULN) or total bilirubin (T BIL) ≥1.5 x ULN. - A participant must not have a history of serologically confirmed hepatic dysfunction (defined as viral infection [Hepatitis B, C, or E; Epstein-Barr virus (EBV); cytomegalovirus (CMV)]) or a history of diagnosis of drug- or alcohol- induced hepatic toxicity or frank hepatitis. - A participant must not have a history within the past 5 years of a primary or recurrent malignant disease with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with a normal prostate-specific antigen (PSA) post resection. - A participant must not have received certain prespecified medications for a prespecified time window before the trial. - A participant must not have an average daily consumption of more than three 4 ounce glasses (118 mL) of wine or the equivalent. - A participant must not have a severe or ongoing unstable medical condition (eg, any form of clinically significant cardiac disease, symptomatic orthostatic hypotension, seizures, or alcohol/drug dependence). - A participant must not have allergy/sensitivity to investigational product(s) or its/their excipients. - A participant must not be breast-feeding, considering breast-feeding, pregnant, or intending to become pregnant. - A participant must not have used preladenant ever, or any investigational drugs within 90 days immediately before Screening. | |
| 98 | NCT00387010 | terminated | the sponsor felt enough information was available for the exploratory assessment of the effect of treatment with fbt on pain anxiety | 0 | phase 3 | ['pain', 'chronic pain', 'breakthrough pain'] | ["['N50.82', 'R07.2', 'R07.82', 'R10.13', 'R10.33', 'R14.1', 'R52']", "['G89.29', 'G89.4', 'R39.82', 'G89.22', 'G89.28', 'G89.21', 'G89.3']"] | ['fentanyl buccal tablets'] | ['CCC(=O)N(C1CCN(CCC2=CC=CC=C2)CC1)C1=CC=CC=C1'] | Inclusion Criteria: - The patient is willing to provide written informed consent to participate in this study. - The patient is 18 through 80 years of age. - Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of birth control (i.e., barrier method with spermicide, steroidal contraceptive [oral, transdermal, implanted, and injected contraceptives must be used in conjunction with the barrier method], or intrauterine device [IUD]) and agree to continued use of this method for the duration of the study. - The patient has chronic pain of at least 3 months duration associated with any of the following conditions: cancer, diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia (patient has met diagnostic criteria), chronic pancreatitis, or osteoarthritis. Other chronic painful conditions may be evaluated for entry upon discussion with and written approval from the Cephalon medical expert. - The patient is currently using 1 of the following: at least 60 mg of oral morphine/day, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oxycodone/day, or at least 8 mg of hydromorphone/day, or an equianalgesic dose of another opioid/day as a stable dose of around-the-clock (ATC) therapy for at least 7 days prior to enrollment in the study. - The patient reports an average pain intensity score, over the prior 24 hours, of 6 or less (0=no pain through 10=worst pain) for the chronic pain. - The patient experiences, on average, 1 to 4 BTP episodes per day while taking around-the-clock (ATC) opioid therapy, and on average, the duration of each breakthrough pain (BTP) episode is less than 3 hours. - The patient currently uses opioid therapy for alleviation of BTP episodes occurring at the location of the chronic pain, and achieves at least partial relief. - The patient must be willing and able to successfully self-administer the study drug, comply with study restrictions, and return to the clinic for scheduled study visits and a follow-up evaluation as specified in this protocol. Exclusion Criteria: - The patient has uncontrolled or rapidly escalating pain as determined by the investigator (ie, the ATC therapy may be expected to change between the first and last treatments with study drug), or has pain uncontrolled by therapy that could adversely impact the safety of the patient or that could be compromised by treatment with study drug. - The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in the study drug. - The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse. - The patient has cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of treatment with potent synthetic opioids. - The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data. - The patient's primary painful condition is headache, including migraine. - The patient is expected to have surgery during the study, and it is anticipated that the surgery will alleviate the patient's pain. - The patient has had therapy before study drug treatment that, in the opinion of the investigator, could alter pain or response to pain medication. - The patient is pregnant or lactating. - The patient has participated in a previous study with fentanyl buccal tablets. - The patient has participated in a study involving an investigational drug in the previous 30 days. - The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug. - The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that, in the opinion of the investigator, would compromise the patient's safety or compliance with the study protocol, or compromise collected data. - The patient is involved in active litigation in regard to chronic pain currently being treated. - The patient has a positive urine drug screen (UDS) for an illicit substance or a medication not legitimately prescribed to the patient. |
| 99 | 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)'] | ['[Fe+3].[Fe+3].[Fe+3].[Fe+3].OP(O)(=O)OP(O)(O)=O.OP(O)(=O)OP(O)(O)=O.OP([O-])(=O)OP([O-])([O-])=O.OC(CC([O-])=O)(CC([O-])=O)C([O-])=O.OC(CC([O-])=O)(CC([O-])=O)C([O-])=O.OC(CC([O-])=O)(CC([O-])=O)C([O-])=O'] | 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. | |
| 100 | NCT00260156 | completed | 1 | phase 3 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['vildagliptin', 'placebo'] | ['CN(C)C(=N)NC(N)=N', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Not currently on drug therapy for type 2 diabetes - Blood glucose criteria must be met Exclusion Criteria: - History of type 1 diabetes - Evidence of significant diabetic complications - Serious cardiovascular events within the past 6 months - Other protocol-defined exclusion criteria may apply |