Downloads: 1
| # | nctid | status | why_stop | label | phase | diseases | icdcodes | drugs | smiless | criteria |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00475085 | completed | 1 | phase 3 | ['nausea'] | ["['R11.0', 'R11.11', 'R11.2']"] | ['aprepitant', 'dexamethasone', 'granisetron hydrochloride', 'palonosetron hydrochloride', 'prochlorperazine', 'placebo'] | ['[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', 'C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F', 'CN1N=C(C(=O)N[C@@H]2C[C@@H]3CCC[C@H](C2)N3C)C2=C1C=CC=C2', '[H][C@]12CCCC3=C1C(=CC=C3)C(=O)N(C2)[C@@H]1CN2CCC1CC2', 'CN1CCN(CCCN2C3=CC=CC=C3SC3=C2C=C(Cl)C=C3)CC1', '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 cancer and be chemotherapy naive. - Must be scheduled to receive a chemotherapy treatment containing doxorubicin hydrochloride, epirubicin hydrochloride, cisplatin, carboplatin, or oxaliplatin (any dose or schedule) without concurrent radiotherapy or interferon treatment - Chemotherapy may be for adjuvant, neoadjuvant, curative or palliative intent. - Dose-dense regimens (e.g. chemotherapy with doxorubicin or epirubicin given every two weeks)are allowed. - For the purposes of this study, Day 1 of chemotherapy will be defined as the day of administration of cisplatin, carboplatin, oxaliplatin, doxorubicin or epirubicin. - Regimens with multiple-day doses of doxorubicin, epirubicin, cisplatin, carboplatin, oxaliplatin, dacarbazine, hexamethylmelamine, nitrosoureas, or streptozocin are not allowed. Chemotherapy agents, other than those listed above, may be given orally, intravenously, or by continuous infusion on one or multiple days. - Able to understand English Exclusion criteria: - No symptomatic brain metastases - No concurrent or impending bowel obstruction - Regimens containing liposomal doxorubicin or cisplatin are not allowed. - No concurrent pimozide, terfenadine, astemizole, or cisapride - No concurrent doxorubicin hydrochloride liposome or cisplatin - No concurrent multiple-day doses of dacarbazine, altretamine, nitrosoureas, streptozocin, cisplatin, carboplatin, or oxaliplatin | |
| 2 | NCT01626859 | completed | 1 | phase 2/phase 3 | ['schizophrenia'] | ["['F20.0', 'F20.1', 'F20.2', 'F20.3', 'F20.5', 'F20.89', 'F20.9']"] | ['mp-214 low dose', 'mp-214 middle dose', 'mp-214 high dose'] | ['CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(CC2)C2=C(Cl)C(Cl)=CC=C2)CC1', 'CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(CC2)C2=C(Cl)C(Cl)=CC=C2)CC1'] | Inclusion Criteria: - Written informed consent obtained from the patient before the initiation of any study-specific procedures - Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia - 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 | |
| 3 | NCT00203957 | completed | 1 | phase 3 | ["parkinson's disease"] | ["['G20']"] | ['istradefylline', 'istradefylline'] | ['[H]\\C(=C(\\[H])C1=CC(OC)=C(OC)C=C1)C1=NC2=C(N1C)C(=O)N(CC)C(=O)N2CC', '[H]\\C(=C(\\[H])C1=CC(OC)=C(OC)C=C1)C1=NC2=C(N1C)C(=O)N(CC)C(=O)N2CC'] | Inclusion Criteria: - Patients who completed double-blind treatment study 6002-US-0 13, 6002-US-0 18 or 6002-EU-007, or who discontinued from open-label study 6002-US-007. - Patients who are female must be non-pregnant and non-nursing. Women of Child Bearing Potential (WOCBP) must use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double- bather methods, such as condom and diaphragm, condom and foam, condom and sponge or intra-uterine devices) and have a negative serum (North American sites) or urine (non-North American sites) pregnancy test at screening and at baseline. Women are considered to not be of childbearing potential if they have been surgically sterilized. - Patients who are able to give written informed consent Exclusion Criteria: - Group B Patients who are treated within 30 days before baseline (or five half-lives of the compound, if longer) with any investigational agent other than istradefylline - Patients who have a history of a psychotic illness. - Patients who are treated within three months (six months if patient was treated with depot) before baseline or during the trial with an anti-psychotic agent. - Patients who are treated with any centrally acting drug that has known dopamine antagonist properties at therapeutic doses (e.g., buspirone, amoxapine). - Patients who have atypical parkinsonism. - Patients who have secondary parkinsonism variants. - Patients who have a diagnosis of cancer or evidence of continued malignancy within five years of study enrollment (except for patients that have had basal cell carcinoma or carcinoma in situ of the cervix surgically excised). - Patients who have a clinically significant illness of any organ system which may compromise the safety of the patient during the trial or affect the ability of the patient to complete the trial. - Patients who, for any reason, are judged by the Investigator to be inappropriate for this trial, including a patient who is unable to communicate or to cooperate with the Investigator. - Patients who have an ALT and/or an AST level greater than 1.5 ULN at screening will be ineligible to participate in the trial. - Patients who have a history of drug or alcohol abuse or dependence within the last year (DSM-IVR). - Patients with significant drug allergies. | |
| 4 | NCT00169832 | completed | 0 | phase 3 | ['diabetes', 'coronary artery bypass grafting'] | ["['E23.2', 'N25.1', 'P70.2', 'O24.92', 'Z83.3', 'Z86.32', 'E10.65']", "['I25.84', 'I25.41', 'I25.42', 'Z98.61', 'Q24.5', 'T46.3X6S', 'I25.82']"] | ['rosiglitazone or placebo'] | ['CN(CCOC1=CC=C(CC2SC(=O)NC2=O)C=C1)C1=CC=CC=N1'] | Inclusion Criteria: AT SCREENING: 1. Male or female, aged ≥ 40 years & ≤ 75 years. 2. Women of childbearing potential with contraceptive measure, or of non-childbearing potential or surgically sterile. 3. Type 2 diabetes mellitus. 4. Patients with no new medication for hyperglycemia and no change in dose of oral hypoglycemic medication within the last 3 mo prior to screening. 5. Diabetic patients with ischemic heart disease and CABG with at least one SVG (≥1 yr & ≤10 yrs). 6. Patient agrees to participate. 7. Patient legally capable of giving consent and understand what participation in study entails, potential risks and benefits, freedom to withdraw without any prejudice to subsequent medical arrangement or treatment, sign an ICF prior to any protocol specific procedure. AT IVUS & ANGIOGRAPHY (VISIT 2): Subject eligible if at least 1), 2) and 3) of the following criteria apply: 1. Patient with at least 1 patent SVG. 2. Segment length of at least 40 mm in SVG suitable for IVUS. 3. Reference of target (SVG) diameter ≥ 2.5 mm. If anastomosed native coronary artery or non grafted coronary artery can be evaluated, the following criteria must be met: 4. Reference of target anastomosed native coronary artery or non grafted coronary artery diameter≥ 2.5 mm. 5. Segment length of at least 20 mm in anastomosed native coronary artery corresponding to SVG chosen or, in case of impossibility of performing IVUS in the anastomosed coronary artery, a non grafted coronary artery (≥ 30 mm length segment) might be used for reference. Exclusion Criteria: AT SCREENING: 1. Clinically significant abnormality at screening tests & exams. 2. Type 1 diabetes or history of diabetic ketoacidosis. 3. Uncontrolled type 2 diabetes mellitus. 4. Recent MI or ACS (≤ 90 days). 5. History of hypersensitivity to thiazolidinediones (TZD) or compounds of similar chemical structures. 6. Last LVEF≤ 35%. 7. SBP>170mmHg or DBP>100mmHg at screening/baseline should be appropriately treated and under control prior to randomization. 8. Unstable or Canadian Cardiovascular Society class III and IV angina, acute heart failure or congestive heart failure (NYHA class III and IV). 9. History of hepatocellular reaction/severe oedema/other potentially fluid-related AE associated with use of any TZD or PPAR-γ agonist. 10. Hepatic disease. 11. Renal dysfunction. 12. Anemia. 13. TG ≥ 10 mmol/L. 14. History of PCI in all SVG(s). 15. Known occlusion(s) of all SVG(s). 16. Treatment involving TZD within 3 mo prior to screening. 17. Chronic use (≥ 6 mo) of insulin for glycemic control at any time in the past or administration of insulin any time within the last 12 mo. 18. Allergy to contrast agents. 19. Current intake of anorectic agents or have been taken off an anorectic agent or equivalent within 3 mo prior to screening. 20. Patients for whom oral or injectable corticosteroids are used on a regular or recurrent basis. 21. Recent history/suspicion of current drug abuse or alcohol abuse within last 6 mo. 22. Women breast feeding, pregnant, or planning to become pregnant during conduct of trial and for 30 days after study completion. 23. Other illness that precludes survival. 24. History of malignancy within the last 5 yrs. 25. Concurrent participation in other investigational device or drug studies and/or having received any experimental therapeutic agents within 30 days of the screening. 26. Use of any investigational drug for glycemic control within 3 mo of the screening. 27. Patient travelling out of town/country for periods exceeding 2 mo. 28. Medical condition which may interfere with intake and/or absorption of study medication. 29. Patients unwilling or unable to comply with procedures. 30. Recent major surgery within 90 days of the screening. AT IVUS AND ANGIOGRAPHY (VISIT 2): 1. PCI was performed on the target segment(s) after CABG. 2. Target SVG and/or target native coronary artery show ≥ 50% angiographic lesion precluding IVUS. 3. Thrombus/thrombus aspect in target vessels. 4. Target vessel has been subjected to surgical endarterectomy. | |
| 5 | NCT01249352 | completed | 1 | phase 2/phase 3 | ['esophageal cancer', 'adenocarcinoma'] | ["['K22.2', 'K22.81', 'Q39.4', 'P78.83', 'I85.00', 'I85.01', 'I85.10']", "['C22.0', 'C22.1', 'C4A.9', 'C7B.1', 'D09.9', 'C4A.0', 'C4A.31']"] | ['nimotuzumab', 'cisplatin', 'fluorouracil'] | ['[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', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | Inclusion Criteria: 1. Age ≥ 18 years; 2. Histological prove of SCC or esophageal adenocarcinoma; 3. T1N1M0, T2N1M0, T3N0M0, T4N0M0, T3N1M0, T4N1M0, qqTqqNM1a stage, according to the TNM system42; 4. Life expectation above 6 months; 5. Inoperable superior, medial, or distal third esophageal cancer, including GE junction tumors, defined as type I and II tumors in the Siewert classification43 (see Appendix B); 6. Performance status 0, 1, or 2, according to the Eastern Cooperative Oncology Group criteria44 (ECOG) (see Appendix C); 7. Creatinine clearance ≥ 60 ml/min, according to the Cockcroft and Gault formula45 (see Appendix D); 8. Adequate body functions, indicated by - Creatinine clearance ≥ 60 ml/min; - Bilirubin, transaminase, alkaline phosphatase, and gamma-GT < 1,5 x the upper limit of normal; - leucocytes ≥ 3000/μl; - granulocytes ≥ 1500/ μl; - hemoglobin ≥ 9 g/dl; - platelets ≥ 80000/ μl; 9. Adequate calorie ingestion, at the investigator's discretion; 10. He/she must have signed the informed consent form Exclusion Criteria: 1. Previous or planned treatment of esophageal carcinoma with surgery, radiotherapy, chemotherapy, or antineoplastic biological therapy; 2. Presence of active infection; 3. Knowledge of the presence of HIV seropositivity; 4. Presence of severe comorbidities that, in the investigator's opinion, will put the patient at a significantly higher risk or will damage the protocol compliance; 5. Presence of a significant neurological or psychiatric disease, including dementia and seizures, as per the investigator's judgment; 6. History of malignant neoplasm, except for adequately treated skin basal carcinoma or SCC, and cervical carcinoma in situ; 7. Presence of peripheral neuropathy; 8. Knowledge of the presence of hypersensitivity or allergy to drugs that will be administered in this protocol; 9. History of severe allergic reaction; 10. Pregnancy or lactation; 11. Presence of aerodigestive fistula (trachea and/or bronchia); 12. Evident presence of trachea and/or bronchia infiltration by the tumor; 13. Presence of uncontrolled hypercalcaemia ≥ 2.9 mmol/L (or grade >1, according to the NCI-CTCAE, version 3.0). | |
| 6 | NCT00073528 | completed | 1 | phase 3 | ['breast neoplasms'] | ["['C79.81', 'D24.1', 'D24.2', 'D24.9', 'D49.3', 'C44.501', 'D48.60']"] | ['lapatinib', 'letrozole', 'placebo'] | ['CN(C1=CC2=NN(C)C(C)=C2C=C1)C1=CC=NC(NC2=CC=C(C)C(=C2)S(N)(=O)=O)=N1', 'N#CC1=CC=C(C=C1)C(N1C=NC=N1)C1=CC=C(C=C1)C#N', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Key inclusion criteria 1. Signed informed consent; 2. Subjects with histologically confirmed invasive breast cancer with stage IV disease at primary diagnosis or at relapse after curative-intent surgery; - Subjects with either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST). - If the disease was restricted to a solitary lesion, its neoplastic nature was confirmed by cytology or histology. 3. Tumors that were ER+ and/or PgR+; 4. Post-menopausal female subjects ≥ 18 years of age. 5. ECOG Performance Status of 0 or 1; 6. Subjects who had archived tumor tissue available to compare tumor response with intra-tumoral expression of ErbB1 and ErbB2. 7. Adjuvant therapy with an aromatase inhibitor and / or trastuzumab was allowed; however, treatment was to stop more than 1 year prior (>12 months) to the first dose of randomized therapy. 8. Subjects must have ended hormonal replacement therapy (HRT) at least 1 month (30 days) prior to receiving the first dose of randomized therapy. Key exclusion criteria: 1. Pre-menopausal, pregnant, or lactating; 2. Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for advanced or metastatic disease; 3. Bisphosphonate therapy for bone metastases was allowed; however, treatment was to be initiated prior to the first dose of randomized therapy. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, was not permitted; 4. Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy (lapatinib or placebo); 5. Subjects with known history of/clinical evidence of CNS metastases or leptomeningeal carcinomatosis; and / or subjects on concurrent anti-cancer therapies other than letrozole; and / or who have not recovered from toxicities related to prior adjuvant therapy (surgery, radiotherapy, chemotherapy etc.) 6. Subjects with active or uncontrolled infection and/ or with history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure. | |
| 7 | NCT00430118 | completed | 1 | phase 3 | ['leukemia'] | ["['C95.91', 'C95.92', 'Z80.6', 'Z85.6', 'C90.11', 'C90.12', 'C91.01']"] | ['asparaginase', 'cyclophosphamide', 'cytarabine', 'daunorubicin hydrochloride', 'dexamethasone', 'doxorubicin hydrochloride', 'etoposide', 'ifosfamide', 'mercaptopurine', 'methotrexate', 'prednisone', 'thioguanine', 'vincristine sulfate', 'vindesine'] | ['N[C@@H](CC(O)=O)C(O)=O', 'ClCCN(CCCl)P1(=O)NCCCO1', '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(C)=O)C(O)=C1C2=O', 'C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F', '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', 'N[C@@H](CCCNC(N)=N)C(O)=O', 'S=C1N=CNC2=C1NC=N2', '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', '[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', 'NC1=NC(=S)C2=C(N1)N=CN2', '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', '[H][C@@]12N3CC[C@@]11C4=C(C=C(OC)C(=C4)[C@]4(C[C@@H]5C[N@@](C[C@](O)(CC)C5)CCC5=C4NC4=CC=CC=C54)C(=O)OC)N(C)[C@@]1([H])[C@](O)([C@H](O)[C@]2(CC)C=CC3)C(N)=O'] | DISEASE CHARACTERISTICS: - Histologically confirmed acute lymphoblastic leukemia (ALL) - No secondary ALL PATIENT CHARACTERISTICS: - No prior disease that would preclude treatment with chemotherapy PRIOR CONCURRENT THERAPY: - More than 4 weeks since prior chemotherapy - More than 4 weeks since prior steroids | |
| 8 | NCT00605293 | completed | 1 | phase 3 | ['anemia'] | ["['D53.2', 'D64.9', 'D46.4', 'D53.0', 'D53.9', 'D61.3', 'D61.9']"] | ['methoxy polyethylene glycol-epoetin beta', 'epoetin alfa'] | ['OC(=O)CNC(=O)C1C(=O)N(C2CCCCC2)C(=O)N(C2CCCCC2)C1=O'] | Inclusion Criteria: - chronic renal anemia; - continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP; - regular hemodialysis for greater than or equal to (>=) 3 months Exclusion Criteria: - transfusion of red blood cells during previous 2 months - poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months; | |
| 9 | NCT00331864 | completed | 1 | phase 3 | ['age related macular degeneration', 'choroidal neovascularization'] | ["['H35.3130', 'H35.3230', 'H35.3110', 'H35.3120', 'H35.3131', 'H35.3132', 'H35.3190']", "['H44.2A1', 'H44.2A2', 'H44.2A3', 'H44.2A9', 'H35.3231', 'H35.3232', 'H35.3211']"] | ['ranibizumab'] | ['CN\\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O'] | Patients who participated in this study included those who had completed participation in the study CRFB002A2301 (ANCHOR; NCT00061594), newly diagnosed patients, as well as previously diagnosed patients who had had recent disease progression. Inclusion Criteria: - Male or female patients > 50 years of age - Diagnosis of active primary or recurrent CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component - The total area of CNV (including both classic and occult components) encompassed within the lesion must be >= 50% of the total lesion area - The total lesion area must be <= 12 disc areas - Patients who have a BCVA (best corrected visual acuity) score between 73 and 24 letters, inclusive, in the study eye using ETDRS-like (Early Treatment of Diabetic Retinopathy Study) grading charts (approximately 20/40 to 20/320) Exclusion Criteria: - Patients who have a BCVA of < 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters) - Laser photocoagulation, treatment with intravitreal steroids, verteporfin photo dynamic therapy or pegaptanib sodium in the study eye within 30 days preceding Day 1 - Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.) Other protocol-defined inclusion/exclusion criteria may apply. | |
| 10 | NCT01061190 | completed | 0 | phase 2/phase 3 | ['stroke'] | ["['G46.4', 'G46.3', 'Z82.3']"] | ['propranolol'] | ['COCCC1=CC=C(OCC(O)CNC(C)C)C=C1'] | Inclusion Criteria: - Symptom onset within 18 hours - Acute ischemic MCA-territory stroke - Patients with suspected stroke in MCA-territory and a) NIHSS > 3 or b) imaging evidence of MCA-infarction Exclusion Criteria: - Patients already receiving beta-blockers - Anti-arrhythmic, antiinfectious, antiinflammatory or immunosuppressive therapy - Patients with a major heart disease, hypotension, bradycardia or any contraindication to the use of Propranolol | |
| 11 | NCT00516139 | completed | 1 | phase 3 | ['epilepsy'] | ["['G40.803', 'G40.804', 'G40.911', 'G40.919', 'G40.B11', 'G40.B19', 'G40.801']"] | ['lamotrigine'] | ['NC1=NC(N)=C(N=N1)C1=C(Cl)C(Cl)=CC=C1'] | Inclusion criteria: - Confident diagnosis of epilepsy - Currently treated with one or two antiepileptic medications - Able to complete a seizure diary Exclusion criteria: - History of hypersensitivity to lamotrigine - Progressive diseases that would interfere with the study objectives | |
| 12 | NCT00124982 | completed | 1 | phase 3 | ['rheumatoid arthritis'] | ["['M06.9', 'M05.9', 'M06.08', 'M06.00', 'M06.011', 'M06.012', 'M06.019']"] | ['abatacept', 'non-biologic disease modifying anti-rheumatic drug (dmard)', 'anti-tumor necrosing factor (tnf) therapy'] | ['[H][C@@]12CCCN1C(=O)[C@H](CC1=CC=CC=C1)N1C(=O)[C@](C)(NC(=O)[C@H]3CN(C)[C@]4([H])CC5=CNC6=CC=CC(=C56)[C@@]4([H])C3)O[C@@]21O'] | Inclusion Criteria: - Completed double-blind portion of the IM101064 study. - Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis - American College of Rheumatology (ACR) functional class I, II, III - Subjects currently or previously received an anti-TNF therapy at an approved labeled dose for at least 3 months Exclusion Criteria: - Subjects with active vasculitis of a major organ system (except subcutaneous rheumatoid nodules) - History of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection) | |
| 13 | NCT01064310 | completed | 1 | phase 3 | ['carcinoma, renal cell'] | ["['C22.0', 'C4A.9', 'C7B.1', 'C4A.0', 'C4A.31', 'C4A.51', 'C4A.8']"] | ['pazopanib', 'sunitinib'] | ['ClCCN(CCCl)P1(=O)NCCCO1', 'CNC(=O)C1=C(SC2=CC=C3C(NN=C3\\C=C\\C3=CC=CC=N3)=C2)C=CC=C1'] | Inclusion Criteria: - Patients must provide written informed consent prior to performance of any study-specific procedures or assessments and must be willing to comply with treatment and follow up. Procedures conducted as part of the patient's routine clinical management (e.g. blood count, imaging study) and obtained prior to signing of informed consent may be utilised for screening or baseline purposes provided these procedures are conducted as specified in the protocol. - Received no prior systemic therapy (including interleukin-2, interferon-alpha, chemotherapy, bevacizumab, mTOR inhibitor, sunitinib, sorafenib or other VEGF TKI) for advanced or metastatic RCC. Patients who received adjuvant treatment with a cancer vaccine are eligible. - Locally advanced (defined as disease not amenable to curative surgery or radiation therapy) or metastatic renal cell carcinoma of any histology (equivalent to Stage IV RCC according to AJCC staging). Patients with non-measurable disease are allowed if metastatic disease can be confirmed. - ECOG PS of 0 or 1 - Age >= 18 years - A female is eligible to enter and participate in this study if she is of: Non-childbearing potential (i.e. physiologically incapable of becoming pregnant) Childbearing potential, including any female who has had a negative serum pregnancy test within two weeks prior to the first dose of study treatment, preferably as close to the first dose as possible and agrees to use adequate contraception. - Adequate organ system functions - Total serum calcium concentration <12.0mg/dL - Left ventricular ejection fraction (LVEF) >=lower limit of institutional normal (LLN) as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan. The same modality used at baseline must be applied for subsequent evaluations. - Patient is able to swallow and retain oral tablets Exclusion Criteria: - Poor MSKCC risk group - History of another malignancy. Note: Patients who have had another malignancy and have been disease-free for 3 years or patients with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible. - History or clinical evidence of central nervous system (CNS) metastases. Note: Patients who have previously-treated CNS metastases (surgery +/- radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible: - Are asymptomatic, - Have had no evidence of active CNS metastases for >=6 months prior to enrolment , - Have no requirement for steroids or enzyme-inducing anticonvulsants (EIAC). - Any clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding or affect absorption of investigational product including, but not limited to: - Malabsorption syndrome - Major resection of the stomach or small bowel that could affect the absorption of study drug - 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 28 days prior to beginning study treatment. - Presence of uncontrolled infection. - Corrected QT interval (QTc) >480 msecs using Bazett's formula - History of one or more of the following cardiovascular conditions within the past 6 months: - Cardiac angioplasty or stenting - Myocardial infarction - Unstable angina - Coronary artery bypass graft surgery - Symptomatic peripheral vascular disease - Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) - Poorly controlled hypertension (defined as systolic blood pressure (SBP) of > 150mmHg or diastolic blood pressure (DBP) of > 90mmHg) at baseline. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour within a visit. The mean SBP/DBP values from each blood pressure assessment must be <=150/90mmHg in order for a patient to be eligible for the study. - History of cerebrovascular accident (CVA) including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Patients with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible. - Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major). - Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels. - Evidence of active bleeding or bleeding diathesis. - Significant haemoptysis within 6 weeks prior to first dose of study drug. - 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. - Use any prohibited medications within 14 days of the first dose of study medication. - Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug. - Radiation therapy, surgery or tumour embolisation within 14 days prior to the first dose of study treatment. - Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or sunitinib. - Pregnant or lactating female Female patients who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug. | |
| 14 | NCT00670306 | completed | 1 | phase 3 | ['benign prostatic hypertrophy'] | ["['J35.3', 'J35.1', 'J35.2', 'N28.81', 'N62', 'N85.2', 'J34.3']"] | ['cetrorelix pamoate'] | ['CC(C)C[C@H](NC(=O)[C@@H](CCCNC(N)=O)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@@H](CC1=CN=CC=C1)NC(=O)[C@@H](CC1=CC=C(Cl)C=C1)NC(=O)[C@@H](CC1=CC2=CC=CC=C2C=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'] | Inclusion Criteria: - Benign Prostatic Hyperplasia, based on medical history - Voiding symptoms - Uroflow (max) 5-15mL/sec Exclusion Criteria: - Urgent need for prostate surgery - History of allergic reaction to peptide - Major organ dysfunction - Prior surgical treatment of the prostate or bladder - Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior to trial medication at Week 0 or with α blockers or saw palmetto within the last 6 weeks prior to trial medication at Week 0 - Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy - History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months | |
| 15 | NCT00662714 | completed | 1 | phase 3 | ['cystic fibrosis', 'diabetes mellitus'] | ["['E84.9', 'Z14.1', 'E84.0', 'E84.11', 'E84.8', 'E84.19', 'P09.4']", "['P70.2', 'O24.92', 'Z83.3', 'E10.65', 'E10.9', 'E11.65', 'E11.9']"] | ['repaglinide', 'short-acting insulin (actrapid)'] | ['CCOC1=C(C=CC(CC(=O)N[C@@H](CC(C)C)C2=CC=CC=C2N2CCCCC2)=C1)C(O)=O', '[Na+].[Na+].[O-]P([O-])(F)=O'] | Inclusion Criteria: Inclusion Criteria for the Screening: - Diagnosed cystic fibrosis - Age 10 years and older Inclusion Criteria for the therapeutic part of the study: - Newly diagnosed Diabetes mellitus in the screening Exclusion Criteria: Exclusion Criteria for Screening: - Diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25) - Already treated Diabetes mellitus by oral antidiabetic medication or insulin Exclusion Criteria for the therapeutic part of the study: - Systemic steroid therapy during the last 3 months - Transplantation (status post TX or on the waiting list for TX) - Beginning pulmonary insufficiency, FEV1 < 35% at pulmonary function test in stable condition - Pregnancy - Already diagnosed and treated diabetes mellitus - Patients with diabetic keto-acidosis (blood glucose > 350 mg/dl and arterial pH < 7.25) with or without diabetic coma - Severe liver insufficiency (chronic hepatitis B, AST or ALT twice the upper limit of normal, Quick's value < 70% which is a contraindication to use Repaglinide) - Treatment with an indispensable important drug which contraindicates Repaglinide - PEG/ gastric tube/ total parenteral alimentation for more than 4 weeks during the study - CF-patients with type 1 diabetes - Not patient's consent to randomisation and therapeutic trial - Participation on other medical trial | |
| 16 | NCT00337727 | completed | 1 | phase 3 | ['chemotherapy-induced nausea and vomiting'] | ["['D61.810']"] | ['aprepitant', 'comparator: ondansetron', 'comparator: dexamethasone', 'comparator: fosaprepitant dimeglumine', 'comparator; placebo (unspecified)', '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', 'CN1C2=C(C3=CC=CC=C13)C(=O)C(CN1C=CN=C1C)CC2', '[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', 'C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F', '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: - Patients will be naive to emetogenic chemotherapy with histologically or cytologically confirmed malignant disease scheduled to receive a single dose of moderately emetogenic chemotherapy on study day 1 - Karnofsky score of 60 or greater Exclusion Criteria: - Patient is scheduled to receive any dose of cisplatin - Patient will receive abdominal or pelvic radiation a week prior and up to 6 days after initiation of chemotherapy - Any allergies to study drug or antiemetics - Taking CYP3A4 substrates/prohibited medication - Significant medical or mental conditions - Abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine). | |
| 17 | NCT00608205 | completed | 1 | phase 3 | ['head and neck cancer'] | ["['C76.0', 'C47.0', 'C49.0', 'C77.0', 'D17.0', 'D21.0', 'D36.11']"] | ['cisplatin', 'fluorouracil'] | ['[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', '[H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1'] | DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx - No histologic diagnosis other than squamous cell carcinoma - A primary site must be identified - Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease - No evidence of nodal disease below the clavicles or distant hematogenous metastases (M0) - No stage IVC disease (stage IVB disease allowed) - Deemed appropriate for definitive non-operative management with curative intent - Resectable disease is not required - No primary cancer of the nasopharynx, paranasal sinus, or salivary gland PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - WBC > 3,500/mm³ - Platelet count > 100,000/mm³ - Serum creatinine < 2.0 mg/dL - Alkaline phosphatase < 2 times normal - AST < 2 times normal - Bilirubin ≤ 2.0 mg/dL - Serum calcium normal - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No unstable or uncontrolled angina - No clinically apparent jaundice - No active infection - No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ), unless the patient has been continuously disease-free for at least 5 years - Not a poor compliance risk - Able to withstand the rigors of intensive treatment - Available for and compliant with adequate long-term follow-up PRIOR CONCURRENT THERAPY: - No prior definitive surgery or radiotherapy for this malignancy - No prior chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for any disease Patients who have had previous definitive surgery, or radiation therapy for this malignancy, and patients who have had any previous chemotherapy, immunotherapy, or EGF receptor inhibition for any disease are ineligible. Exclusion Criteria Patients with primary cancers of the nasopharynx, paranasal sinus or salivary gland are ineligible. Patients with unstable or uncontrolled angina, clinically apparent jaundice, or active infection are ineligible. Patients with a history of any other malignancy (except squamous or basal cell skin cancer or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously disease-free for at least 5 years. Patients with any histologic diagnosis other than squamous cell carcinoma are ineligible. Patients who might be a poor-compliance risk are ineligible. Pregnant or breastfeeding women are ineligible. Women/men of reproductive potential must be willing to practice acceptable methods of birth control to prevent pregnancy. | |
| 18 | NCT00391638 | completed | 0 | phase 2/phase 3 | ['hepatitis b', 'hiv infections'] | ["['B18.0', 'B18.1', 'B19.10', 'B19.11', 'B17.0', 'B16.0', 'B16.1']", "['Z21']"] | ['truvada (emtricitabine + tenofovir df)'] | ['[H][C@@](C)(CN1C=NC2=C(N)N=CN=C12)OCP(=O)(OCOC(=O)OC(C)C)OCOC(=O)OC(C)C'] | Inclusion Criteria: - HIV infection - Karnofsky above 80 per cent - Stable ARV since 4 months - CD4 above 200 per mm3 - ARN VIH below 10000 copies per ml - hepatitis B chronic with : positive antigenaemia HBe and negative antiHBe, positive DNA HBV before or under tenofovir treatment, DNA HBV negative or below 10000 copies per ml at W-8. - Previous treatment by tenofovir and lamivudine or emtricitabine more than 6 months Exclusion Criteria: - HIV 2 infection - Hepatitis C or D - Opportunistic infection - Alcool consummation more than 50g/d - Cirrhosis - Pregnancy or plan of pregnancy - Breastfeeding - Immunosuppressive or modulating of the immune response treatment - Other Hepatitis B treatments than tenofovir, lamivudine or emtricitabine since 6 months - Malabsorption - Exclusive HIV therapy with Truvada - Evolutive cancer under chemotherapy | |
| 19 | NCT01340209 | completed | 1 | phase 3 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['tiotropium respimat', 'placebo respimat', 'tiotropium respimat'] | ['[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 including the patients under age (under 20 years old) must sign and date an Informed Consent Form consistent with ICH-GCP guidelines and Good Clinical Practice (GCP) prior to participation in the trial [i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test (PFT) at Visit 1]. Regarding patients under age, a guardian or a legally authorised representative must also sign and date an Informed Consent Form. 2. Male or female outpatients aged at least 18 years but not more than 75 years at Visit 0. 3. All patients must have at least a 12-week history of asthma at the time of enrolment (Visit 0) into the trial. The diagnosis should be confirmed at Visit 1 by fulfilling inclusion criterion 5. 4. The initial diagnosis of asthma must have been made before the patient's age of 40. 5. The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility (15-30 minutes after 400 µg salbutamol) resulting in a Forced Expiratory Volume in one second (FEV1) increase of at least 12% and at least 200 mL . 6. All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids (ICS) [alone or in a fixed combination with a Long-acting beta-adrenergic (LABA)] for at least 4 weeks prior to Visit 1. 7. 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 at least 1.5. 8. All patients must have a pre-bronchodilator FEV1 at least 60% and less than or equal to 90% of predicted normal at Visit 1. 9. Patients must be never-smokers or ex-smokers who stopped smoking at least one year (52 weeks) prior to enrolment (Visit 0) and who have a smoking history of less than 10 pack years. 10. Patients must be able to use the Respimat inhaler correctly, which is judged at the discretion of the investigator.. 11. Patients must be able to perform all trial related procedures including technically acceptable PFTs and use of electronic diary (eDiary)/peak flow meter, which is judged at the discretion of the investigator. Exclusion criteria: 1. Patients with a significant disease other than asthma. A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial. 2. Patients with a clinically relevant abnormal screening (Visit 1) haematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion no 1. 3. Patients with a recent history (i.e. 6 months or less) of myocardial infarction prior to Visit 0. 4. Patients who have been hospitalised for cardiac failure during the past year prior to Visit 0. 5. Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year prior to Visit 0. 6. Patients with lung diseases other than asthma (e.g. COPD). 7. Patients with known active tuberculosis. 8. Patients with malignancy and/or patients who have undergone resection, radiation therapy or chemotherapy for malignancy within the last 5 years prior to Visit 0. Patients with treated basal cell carcinoma are allowed. 9. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion no. 1. 10. Patients with significant alcohol or drug abuse, which is judged at the discretion of the investigator, within the past 2 years prior to Visit 0. 11. Patients with known hypersensitivity to anticholinergic drugs, benzalkonium chloride (BAC), ethylenediaminetetraacetic acid (EDTA), or any other components of the study medication delivery systems. 12. Pregnant or nursing women. 13. Women of childbearing potential not using a highly effective method of birth control. 14. Patients who have taken an investigational drug within 4 weeks prior to Visit 1. 15. Patients who have been treated with beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period. Topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed. 16. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva) within four weeks prior to Visit 1 and/or during the screening period. 17. Patients who have been treated with oral beta-adrenergics within four weeks prior to Visit 1 and/or during the Screening period. 18. Patients who have been treated with systemic corticosteroids within four weeks prior to Visit 1 and/or during the screening period. 19. Patients who have been treated with anti-IgE antibodies, e.g. omalizumab (Xolair®), within 6 months prior to Visit 1 and/or during the screening period. 20. Patients who have been treated with other non-approved and according to international guidelines not recommended "experimental" drugs for routine asthma therapy within four weeks prior to Visit 1 and/or during the screening period. 21. Patients with any asthma exacerbation or any respiratory tract infection in the four weeks prior to Visit 1 and/or during the screening period. 22. Patients who are currently participating in another trial. 23. Patients with narrow-angle glaucoma and/or micturition disorder due to prostatic hyperplasia. 24. Patients with below 80% of the eDiary completion compliance on Visit 2 (diary compliance of at least 80% is required). | |
| 20 | NCT00722852 | completed | 0 | phase 3 | ['osteoarthritis of the knee'] | ["['M15.4', 'M15.0', 'M16.9', 'M17.9', 'M19.011', 'M19.012', 'M19.019']"] | ['ketoprofen in diractin®', 'placebo'] | ['CC(C(O)=O)C1=CC(=CC=C1)C(=O)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: - Informed consent signed and dated - Age > 45 years - Class I-III OA of the knee and subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee Exclusion Criteria: - Skin lesions or dermatological diseases in the treatment area - Directly or indirectly involved in the conduct and administration of this study - Received any investigational medicinal product within 30 days prior to Screening Visit or participation in any previous clinical study with Diractin® - Pregnancy or lactation - Residents of psychiatric wards, prisons or other state institutions - Malignancy within the past 2 years - Depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study - Epilepsy - Schizophrenia - Neuropathic pain and any other pain condition requiring chronic use of pain medication - Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen and to ingredients of the IMP - Preexisting asthma or bronchospasm after taking aspirin or other NSAIDs - Unable to discontinue analgesic therapy including opioids, NSAID´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study | |
| 21 | NCT00437112 | completed | 0 | phase 3 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['human insulin inhalation powder', 'insulin glargine'] | ['[Na+].[Na+].[O-]P([O-])(F)=O', '[Na+].[Na+].[O-]P([O-])(F)=O'] | Inclusion Criteria: - Type 2 Diabetes Mellitus - Insulin naive - One or more oral antihyperglycemic medications - HbA1c greater than or equal to 8.0% and less than or equal to 10.5% - Non-smoker Exclusion Criteria: - Taking a TZD dose greater than what is indicated - Have not taken insulin within 6 months of entry into study - Have had more than 2 episodes of sever hypoglycemia during the 6 months prior to study entry - Have had more than 1 hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry - Have had pneumonia in the 3 months prior to study entry - Systemic glucocorticoid therapy - Clinical signs or symptoms of liver disease, acute or chronic hepatitis - History of renal transplantation - Have an active or untreated malignancy - Have a current diagnosis or past history of clinically relevant pulmonary disease - Taking or have taken exenatide during the 6 weeks prior to study entry | |
| 22 | NCT00053599 | completed | 0 | phase 3 | ['alzheimer disease'] | ["['G30.8', 'G30.9', 'G30.0', 'G30.1']"] | ['simvastatin'] | ['CC1=CC(O)=CC(C)=C1Cl'] | - Mild to moderate patients with AD who are free of life-threatening disease and who do not require lipid-lowering treatment according to current guidelines. - NINCDS/ADRDA criteria for probable AD. - Mini-Mental-State-Exam (MMSE) score between 12 and 26. - Stable medical condition for 3 months prior to the screening visit. - Age greater than or equal to 50 years, and no upper age limit. - Lives in a community dwelling, not in a nursing home. - Stable doses of (non-excluded) medications with central nervous system activity for 4 weeks prior to the screening visit. - Physical condition acceptable for the study as confirmed by medical history, physical exam, neurologic exam and clinical laboratory tests. - Informant/study partner available and willing to accompany participant to all scheduled visits and complete informant-based assessments and to supervise administration of study medications. - Fluent in English or Spanish. - Modified Hachinski is less than or equal to 4. Exclusion criteria: - Coronary heart disease (CHD) including angina, or peripheral vascular disease including symptomatic carotid artery disease, or stroke or TIA, as these individuals are likely to require treatment with lipid-lowering drugs. - Serious renal disease. - Uncontrolled diabetes. - Triglycerides are greater than 500 mg/dL. - LDL-Cholesterol below 80 mg/dL - Upper limit for the National Cholesterol Education Program (NCEP) guidelines for LDL-Cholesterol is 130-190 mg/dL, depending on age and other cardiovascular risk factors. - Other indication for the need to treat with lipid-lowering drug. - Active liver disease or persistent elevation in serum transaminase. - Active neoplastic disease (skin tumors other than melanoma are not exclusionary; subjects with stable prostate cancer may be included at the discretion of the Project Director). - Use of another investigational agent within 2 months of the screening visit. - History of clinically significant stroke. - Current evidence or history in the past 2 years of seizures, head injury with loss of consciousness and/or immediate confusion after the injury. - Current DSM-IV criteria based diagnosis for major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse. - Blindness, deafness, language difficulties or any other disability which may prevent the subject from participating or cooperating in the protocol. | |
| 23 | NCT01103960 | completed | 1 | phase 3 | ['hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['telmisartan80mg+amlodipine5mg', 'amlodipine 5mg', 'telmisartan80mg+amlodipine 5mg'] | ['CCOC(=O)C1=C(COCCN)NC(C)=C(C1C1=CC=CC=C1Cl)C(=O)OC', 'CCOC(=O)C1=C(COCCN)NC(C)=C(C1C1=CC=CC=C1Cl)C(=O)OC'] | Inclusion criteria: 1. diagnosis of essential hypertension 2. failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy 3. provision of written informed consent Exclusion criteria: 1. clinical conditions which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine for the planned duration of this trial (e.g. populations where labeling of either product recommends against its utilization) | |
| 24 | NCT00554229 | completed | 0 | phase 3 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['zd4054', 'placebo'] | ['COC1=NC(C)=CN=C1NS(=O)(=O)C1=CC=CN=C1C1=CC=C(C=C1)C1=NN=CO1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: Patients who answer TRUE to the following criteria may be eligible to participate in this trial. 1. Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastases) 2. Increasing Prostate Specific Antigen (PSA) over a one month period 3. No pain, or mild pain from prostate cancer 4. Currently receiving treatment with surgical or medical castration Exclusion Criteria: Patients who answer TRUE to the following may NOT eligible to participate in this trial. 1. Currently using opiates based pain killers) 2. Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone) 3. Suffering from heart failure or had a myocardial infarction within last 6 months 4. A history of epilepsy or seizures | |
| 25 | NCT00406419 | terminated | based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in ra. | 1 | phase 3 | ['rheumatoid arthritis'] | ["['M06.9', 'M05.9', 'M06.08', 'M06.00', 'M06.011', 'M06.012', 'M06.019']"] | ['methotrexate', 'ocrelizumab', 'placebo'] | ['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', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion criteria: - Adult patients, ≥18 years of age - Rheumatoid arthritis for ≥ 3 months - Inadequate clinical response to methotrexate at a dose of 7.5-25mg/week for ≥ 12 weeks Exclusion criteria: - Rheumatic autoimmune disease or inflammatory joint disease, other than RA - Prior receipt of any biologic therapy for RA - Concurrent treatment with any DMARD (other than methotrexate) |
| 26 | NCT00382993 | completed | 1 | phase 3 | ['migraine disorders'] | ["['G43.B1', 'G43.D1', 'G43.B0', 'G43.D0', 'G43.A1', 'G43.411', 'G43.419']"] | ['placebo', 'combination product (sumatriptan succinate/naproxen sodium)'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Subject is male or female between 18 and 65 years old. - Subject has migraine with or without aura (2004 ICHD-II criteria). - Subject has 1-8 migraines per month over the previous 3 months and less than 15 total headache days per month. - Subject has recently (within 1 year) discontinued the use of eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan, due to nonresponse or intolerable adverse events. Non-response is defined as documented discontinuation of treatment with eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan for reasons related to response, including (but not limited to): slow onset of efficacy, inconsistent efficacy, inadequate overall efficacy, or inadequate sustained efficacy through 24 hours. Intolerance is defined as documented discontinuation of treatment with eletriptan, rizatriptan, sumatriptan, almotriptan, or zolmitriptan for other reasons, attributable to the triptan, outside of non-response. A female is eligible to enter and participate in this study if she is of: - non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, - child-bearing potential, has a negative urine pregnancy test at screen, and agrees to one of the following acceptable measures of contraception: - Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 5 days); subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit; or, - Female sterilization; or, - Sterilization of male partner; or, - Implants of levonorgestrel; or, - Injectable progestogen; or, - Oral contraceptive (combined or progestogen only); or, - Any intrauterine device (IUD) with published data showing that the highest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or, - Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm); or, - Any other methods with published data showing that the highest expected failure rate for that method is less than 1% per year; or, - Any other barrier methods only if used in combination with any of the above acceptable methods. - Subject taking oral contraceptives has been on a stable regimen for at least 2 months prior to screening. - Subject is willing and able to provide informed consent prior to entry into this treatment phase of the study. - Subject is able to understand and complete the diary card. Exclusion Criteria: Subjects with any of the following criteria may not enroll in the study: - Subject has non-migraine headache, retinal migraine, basilar or hemiplegic migraine, cluster headache, or headaches secondary to trauma, cranial or cervical disorders, infections, alterations of homeostasis, ENT disorders, psychiatric disorders or cranial neuralgias. - Subject has confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina/coronary vasospasm, or signs/symptoms consistent with any of the above. - Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome. - Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study. - Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs). - Subject has a history of congenital heart disease. - Subject has uncontrolled hypertension at screening (sitting systolic pressure ≥140mmHg, diastolic pressure ≥90mmHg). - Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or the presence of risk factors including but not limited to, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age). - Subject has a history of epilepsy or structural brain lesions which lower the convulsive threshold or treated with an antiepileptic drug for seizure control within 5 years prior to screening. - Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study. - Subject is currently taking a monoamine oxidase inhibitor (MAOI), or has taken a MAOI within 2 weeks prior to screening or plans to take within 2 weeks after treatment. - Subject is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; or is taking a medication that is not stabilized (i.e. change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized.. - Subject is currently taking any anti-coagulant (e.g., warfarin). - Subject has a recent history of regular use of opioids or barbiturates for treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months. - Subject is currently taking or has taken in the previous 4 weeks, herbal preparations containing St. John's Wort (Hypericum perforatum). - Subject has hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of their components or any other 5-HT1 receptor agonist. - Subject has a history of allergic reactions to naproxen preparations, including subject in whom aspirin or other NSAID drugs induce the syndrome of asthma, rhinitis, and nasal polyps. - Subject has a history of any gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation. - Subject has a history of gastric bypass or stapling surgery. - Subject has a history of GI ulceration in the past six months or gastrointestinal bleeding in the past year. - Subject has a history of inflammatory bowel disease. - Subject has a history of any bleeding disorder. - Subject is taking any antiplatelet agent (except low-dose aspirin ≤ 325mg/day for cardioprotective reasons). - Subject is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker. - Subject is pregnant, actively trying to become pregnant or breast-feeding. - Subject has evidence of alcohol or substance abuse within the last year which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results. - Subject has any concurrent medical or psychiatric condition which, in the investigator's opinion, may affect the interpretation of efficacy and safety data or which otherwise contraindicates participation in this clinical trial. - Subject has participated in an investigational drug trial within the previous four weeks or plans to participate in another study at any time during this study. | |
| 27 | NCT00537316 | terminated | infusion reactions during re-induction cycles after a period of no treatment in another study [p04563, nct0358670] | 0 | phase 3 | ['ulcerative colitis'] | ["['K51.80', 'K51.813', 'K51.814', 'K51.90', 'K51.913', 'K51.914', 'K51.811']"] | ['azathioprine (aza)', 'placebo to azathioprine', 'placebo infusion'] | ['CN1C=NC(=C1SC1=NC=NC2=C1NC=N2)[N+]([O-])=O', 'CN1C=NC(=C1SC1=NC=NC2=C1NC=N2)[N+]([O-])=O', 'CC1=CC(O)=CC(C)=C1Cl'] | Inclusion Criteria: - must be >=21 years of age at the time of informed consent, of either sex, and of any race; - must have endoscopic evidence of UC, as determined by sigmoidoscopy, within 14 days prior to Baseline; - must have a total Mayo score of 6 to 12 points at Baseline; - must have responded inadequately to corticosteroid treatment (ie, the last or current UC flare did not respond adequately to a standard course of corticosteroids) with or without 5 aminosalicylic acid (5-ASA); - must be off corticosteroids or on a stable dose of corticosteroid for at least 2 weeks prior to enrollment. The maximal daily dose of corticosteroid at Baseline must not exceed the equivalent of 30 mg of prednisone; - must be naïve to infliximab and other tumor necrosis factor-alpha (TNF-α) antagonists; - must be either naïve to AZA/6-MP or have not received AZA/6-MP for at least 3 months before enrollment in the study; - considered eligible according to the following tuberculosis (TB) screening criteria: - have no history of latent or active TB prior to Screening; - have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; - have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of IFX; - within 1 month prior to the first administration of infliximab, either have negative tuberculin skin test OR have a newly identified positive tuberculin test during Screening in which active TB has been ruled out, and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of IFX. - must have a chest X-ray (posterior-anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old active TB; - have had UC for more than 10 years should have had a full colonoscopy within 2 years prior to Screening for the surveillance of dysplasia; - screening and Baseline clinical laboratory tests (complete blood count [CBC] and blood chemistries) must be within predetermined parameters - had been on antibiotics for the treatment of UC (eg, ciprofloxacin and metronidazole) must have been discontinued from them at least 3 weeks prior to Screening; - must be free of any clinically significant condition or situation, other than UC that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study; - willing and able to adhere to the study visit schedule and other protocol requirements; - capable of providing written informed consent, which must be obtained prior to conducting any protocol-specified procedures; - women of child-bearing potential and all men must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Acceptable methods of contraception include condoms (male or 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 (eg, hysterectomy or tubal ligation). Women of child-bearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study; - female participants of childbearing potential must have a negative serum pregnancy test (beta-human chorionic gonadotropin) at Screening and a negative urine pregnancy test at Baseline. Exclusion Criteria: - have severe extensive colitis as evidenced by: - investigator judgment that the participant is likely to require colectomy within 12 weeks of Baseline OR - at least 4 of these symptoms at Screening or Baseline visits, as follows: - diarrhea with >=6 bowel movements/day with macroscopic blood in stool; - focal severe or rebound abdominal tenderness; - persistent fever (>=37.5 degrees C) for at least 3 days prior to baseline; - tachycardia (>100 beats/minute); - hemoglobin <8.5 g/dL (5.3 mM/L). - require, or are required within the 2 months prior to baseline, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage or other conditions possibly confounding the evaluation of disease activity; - have severe, fixed symptomatic stenosis of the large or small intestine; - have current evidence of colonic obstruction or history within the 6 months prior to baseline, confirmed with objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy); - have a history of colonic mucosal dysplasia; - presence on screening endoscopy of adenomatous colonic polyps, if not removed prior to study entry, or history of adenomatous colonic polyps that were not removed; - have the presence of a stoma; - have a history of extensive colonic resection that would prevent adequate evaluation of clinical disease activity (eg, less than 30 cm of colon remaining); - have had a positive stool culture for enteric pathogens, pathogenic ova or parasites within 4 months prior to Baseline unless participant has received treatment and had a negative stool examination 1 week or longer after the end of treatment; - have a concomitant diagnosis of congestive heart failure (CHF), including medically controlled asymptomatic subjects; - have had serious infections (eg, active hepatitis, pneumonia, or pyelonephritis) within 2 months of Screening. Less serious infections (such as acute upper respiratory tract infection [colds] or a simple urinary tract infection) need not be considered as an exclusion at the discretion of the investigator; - have had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis) within 6 months prior to Screening; - have a known infection with human immunodeficiency virus (HIV) and/or hepatitis B or hepatitis C; - have a history of a known allergy to murine proteins or allergy/sensitivity to study drug or its excipients; - have current signs and symptoms of systemic lupus erythematosus, or severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, or cerebral diseases; - have a known history of demyelinating disease suggestive of multiple sclerosis or optic neuritis; - presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to Screening); - have a history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly; - have any current known malignancy or malignancy within 5 years prior to Screening (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence); - have poor tolerability of venipuncture or lack of adequate venous access for required blood sampling and infusion of study drug during the study period; - have had a known substance abuse or dependency (drug or alcohol) within 3 years of Screening; - require chronic (>=1 month) and frequent use (>=3 days per week)of nonsteroidal anti-inflammatory drugs (NSAIDs) except low-dose aspirin for prevention of heart attacks, unstable angina, or transient ischemic attacks; - have other inflammatory diseases that might interfere with the evaluation of the ulcerative colitis; - have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to Screening. - have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of Screening. - have had a chest X-ray within the 3 months prior to the first administration of study agent that shows an abnormality suggestive of malignancy or current active infection, including TB. - have received any specified prohibited treatment more recently than the indicated washout period prior to Screening; - who are participating in any other clinical study or who have received treatment with any investigational drug or device within 3 months prior Screening; - who is part of the staff or a family member of the staff personnel directly involved with this study. |
| 28 | NCT00242606 | completed | 1 | phase 3 | ['epilepsy'] | ["['G40.803', 'G40.804', 'G40.911', 'G40.919', 'G40.B11', 'G40.B19', 'G40.801']"] | ['lamotrigine', 'levetiracetam'] | ['NC1=NC(N)=C(N=N1)C1=C(Cl)C(Cl)=CC=C1', 'CC(C)CC1=CC=C(C=C1)C(C)C(O)=O'] | Inclusion Criteria: - Age ≥ 12 years - Body weight ≥ 30kg (patients 12-15 years of age) and ≥ 40kg (patients over 16 years of age), respectively - Either one epileptic seizure with high risk of relapse (partial seizure semiology, MRI lesion or pathological focal EEG findings) or a newly diagnosed epilepsy (≥ 2 unprovoked seizures) with at least 1 seizure within the past 3 months before begin of trial participance - Treatment with no or a maximum of one anticonvulsant drug at the time of inclusion - Fertile women of ≥ 16 years of age must use at least one of the following contraceptives for at least one month prior to initiation of trial participance: Oral contraceptive, contraceptive diaphragm, intrauterine contraceptive device (coil), tube ligation. For girls between 12 and 15 years of age a written confirmation of sexual abstinence, given by a person having the care and custody of the child, is sufficient. - Informed consent by the proband in written form after being informed about character, relevance and consequences of the clinical trial, and additional informed consent given by a person having the care and custody of the child for patients between 12 and 17 years of age, respectively. Exclusion Criteria: - Patients with non-epileptic seizures or acute symptomatic seizures whose cause can be corrected - Patients who suffer from absence seizures or simple partial seizures without motor signs (aura) only - Patients who had a chronic focal epilepsy or an epileptic state in their medical history - Patients with progressive neurological, degenerative or malignant diseases which are clinically relevant from the investigator's point of view (e.g. cardiovascular or endocrinic diseases) - Patients who have been treated with Levetiracetam or Lamotrigine before - Patients with known manifest renal insufficiency (creatinine clearance < 80 mL/min) - Patients with known hypersensitivity to Levetiracetam, Lamotrigine or another component of the trial drugs - Patients who are attended by a legal guardian - Patients suffering from a psychiatric disease or affective disorders (within the past 6 months), which had to be treated with electric convulsive therapy, tranquilizing agents, monoamine oxidase inhibitors or CNS-active sympathomimetics (e.g. methylphenidate) - Patients who were suffering from alcohol- or drug-addiction within the past 12 months - Pregnant or breast-feeding women - Patients who participated in another clinical trial within the past 30 days | |
| 29 | NCT00473889 | terminated | the study was terminated based on the recommendation by the dsmb following a pre-planned protocol interim analysis because the endpoint was not achieved. | 0 | phase 2/phase 3 | ['stage iiib or iv non-small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['vorinostat', 'comparator: paclitaxel', 'comparator: carboplatin', 'comparator: placebo'] | ['ONC(=O)CCCCCCC(=O)NC1=CC=CC=C1', '[H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C', '[H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H]', 'CN(C)C(=N)NC(N)=N'] | Inclusion Criteria: - Males and females at least 18 years of age who have confirmed diagnosis of Non-small Cell Lung Cancer - Patients with no systemic prior systemic treatment for lung cancer except patients at least 12 months from prior adjuvant therapy - Adequate bone marrow,kidney and liver function - Must be recovered and at least 4 weeks from major surgery or radiation - ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1 - Men and women must agree to use birth control during the study - Women able to have children must have a negative pregnancy test 14 days before study enrollment Exclusion Criteria: - Patients with prior treatment with other investigational agents less than 4 weeks before study enrollment - Pregnant or nursing female patients - Patients who are HIV positive - Patients who have Hepatitis A, B, or C - Patients unable to take study medication by mouth - Patients with untreated brain cancer - Patient eligible for treatment with bevacizumab and for whom bevacizumab is available |
| 30 | NCT01194414 | completed | 1 | phase 3 | ['rheumatoid arthritis'] | ["['M06.9', 'M05.9', 'M06.08', 'M06.00', 'M06.011', 'M06.012', 'M06.019']"] | ['tocilizumab sc', 'tocilizumab iv', 'placebo to tocilizumab sc', 'placebo to tocilizumab iv', 'disease-modifying antirheumatic drugs (dmards)'] | ['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: - Adult participants, ≥ 18 years of age - Rheumatoid arthritis of ≥ 6 months duration, according to American College of Rheumatology (ACR) criteria - Swollen joint count (SJC) ≥ 4 (66 joint count), tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline - Inadequate response to current DMARD therapy - Permitted DMARDs must be at stable dose for ≥ 8 weeks prior to baseline - Oral corticosteroids (≤ 10 mg/day prednisone or equivalent) and NSAIDs (up to maximum recommended dose) must be at stable dose for ≥ 4 weeks prior to baseline Exclusion Criteria: - Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization - Rheumatic autoimmune disease other than RA - Functional class IV (ACR classification) - Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before the age of 16 - Prior history of or current inflammatory joint disease other than RA - Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline - Previous treatment with tocilizumab - Active current or history of recurrent infection | |
| 31 | NCT00348452 | completed | 0 | phase 3 | ['chronic pain'] | ["['G89.29', 'G89.4', 'R39.82', 'G89.22', 'G89.28', 'G89.21', 'G89.3']"] | ['tramadol hcl er; celecoxib'] | ['COC1=CC=CC(=C1)[C@@]1(O)CCCC[C@@H]1CN(C)C'] | Inclusion Criteria: - Patients with American College of Rheumatology (ACR) Functional Class I-III OA of the knee or hip; - Patients with involvement of knee or hip joint that warrants treatment with COX-2 selective inhibitors, NSAIDs, acetaminophen, or opioid analgesics for at least 75 of the 90 days preceding the screening visit; - Patients with a pain intensity score in index joint >= 40 mm on the visual analog scale(VAS) at the baseline visit; - Patients who are able to discontinue acetaminophen, NSAIDS, COX-2 selective inhibitors and other analgesics during the washout period and all analgesics other than the study medication throughout the study; - Patients who are able to understand the study procedures and complete the pain scales. Exclusion Criteria: - Patients with a medical condition, other than OA, uncontrolled with treatment or any clinically significant condition that, in the investigator's opinion, precludes study participation or interferes with the assessment of chronic pain and other OA symptoms; - Patients with a diagnoses of inflammatory arthritis, gout, pseudo-gout or Paget's disease, that, in the investigator's opinion, interferes with the assessment of pain and other symptoms of OA; - Patients with a diagnosis of chronic pain syndrome; - Patients with an ACR or a clinical diagnosis of fibromyalgia; - Patients with any other clinically significant form of joint disease or prior joint replacement surgery at the index joint; - Patients with an anticipated need for surgery or other invasive procedure in the index joint. | |
| 32 | NCT00462540 | completed | 1 | phase 3 | ['chronic obstructive pulmonary disease'] | ["['J44.9', 'J44.1', 'J44.0']"] | ['formoterol fumurate inhalation solution 20 mcg', 'ipratropium bromide 18 mcg and albuterol sulfate 103 mcg'] | ['COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1', '[H][C@]12CC[C@]([H])(C[C@@H](C1)OC(=O)C(CO)C1=CC=CC=C1)[N+]2(C)C(C)C'] | Inclusion Criteria: - Diagnosis of COPD - Smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day - Meet lung function requirements Exclusion Criteria: - Diagnosis of Asthma - Significant disease other than COPD - Female pregnant or lactating or planning to become pregnant | |
| 33 | NCT00500682 | completed | 0 | phase 3 | ['chronic kidney disease'] | ["['I12.9', 'N18.9', 'I12.0', 'D63.1', 'N18.1', 'N18.5', 'I13.0']"] | ['placebo', 'ast-120'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', '[C]'] | Inclusion Criteria: - Age 18 years or older - Moderate to severe CKD, not anticipated to require dialysis or renal transplant within the next 6 months - Patient survival expected to be no less than one year - Serum creatinine in men >= 2.0 mg/dL (>= 177 µmol/L) and <= 5.0 mg/dL (<= 442 µmol/L), and in women >= 1.5 mg/dL (>= 133 µmol/L) and <= 5.0 mg/dL (<= 442 µmol/L) at Screening - Urinary total protein to urinary total creatinine ratio must be >= 0.5 on a spot void at Screening - Blood pressure <= 160/90 mmHg at both Screening and Baseline. In addition, blood pressure, if measured, must have been stable in hypertensive patients over the 3 months prior to Screening, with no more than 1 blood pressure reading > 160/90 mmHg - In patients being treated for hypertension, they should be on a stable anti-hypertensive regimen Exclusion Criteria: - Obstructive or reversible cause of kidney disease - Nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine of > 6.0 as measured on a spot void - Adult polycystic kidney disease - History of previous kidney transplant - History of recent (within the past 6 months) accelerated or malignant hypertension - Uncontrolled arrhythmia or severe cardiac disease within the past 6 months - History of malabsorption, inflammatory bowel disease, hiatal hernia, active peptic ulcer, or severe GI dysmotility, not attributable to the use of a phosphate binder - Received any investigational agent or participated in a clinical study within the previous 3 months - Presence of any significant medical condition that might create an undue risk with study participation, or significantly confound the collection of safety and efficacy data in this study | |
| 34 | NCT00694382 | completed | 1 | phase 3 | ['venous thromboembolism', 'cancer'] | ["['O88.22', 'O88.23', 'O88.211', 'O88.212', 'O88.213', 'O88.219']", "['C05.2', 'C10.0', 'C16.0', 'C16.4', 'C17.0', 'C17.1', 'C17.2']"] | ['semuloparin sodium', 'placebo (for semuloparin)'] | ['\\N', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: Cancer patient with metastatic or locally advanced solid tumor of lung, pancreas, stomach, colon/rectum, bladder or ovary initiating a (new) course of chemotherapy with a minimum intent of 3 months therapy Exclusion Criteria: - Required systematic venous thromboprophylaxis or curative treatment with anti-coagulant or thrombolytic; - High risk of bleeding; - Severe renal impairment (estimated creatinine clearance <30 mL/min); - ECOG (Eastern Cooperative Oncology Group) performance status 3 & 4; - Major surgery within 4 weeks before randomization; - Known hypersensitivity to unfractionated heparin [UFH] or low molecular weight heparin [LMWH]. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial | |
| 35 | NCT00708656 | completed | 1 | phase 3 | ['ulcerative colitis'] | ["['K51.80', 'K51.813', 'K51.814', 'K51.90', 'K51.913', 'K51.914', 'K51.811']"] | ['mesalazine (asacol®)'] | ['NC1=CC(C(O)=O)=C(O)C=C1'] | Inclusion Criteria: Patients who meet the following criteria will be eligible for study entry: - Male and female patients aged over 18 with ulcerative colitis confirmed by histology who are in remission (no symptoms of active disease, and modified Baron sigmoidoscopic score of 0 or 1) - If female, must be (as documented in patient notes): - postmenopausal (at least 1 year without spontaneous menses), or - surgically sterile (tubal ligation or hysterectomy at least 6 months prior to enrollment), or - using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal contraception) at least 3 months prior to enrollment, or - have a sexual partner with non-reversed vasectomy (with confirmed azoospermia), or - be using 1 barrier method (e.g., condom, diaphragm, spermicide, or intra-uterine device) - Patients whose ulcerative colitis has been in clinical remission for 4 weeks or longer, and who have had a symptomatic relapse within the past two years - Patients taking mesalazine, sulfasalazine or other drug containing 5-ASA for 4 weeks or longer - Patients capable of giving written informed consent Exclusion Criteria: The following patients will be excluded from the study: - Patients with Crohn's disease - Patients with symptoms of active colitis - Modified Baron sigmoidoscopy score of 2 or 3 - Patients who have used oral, enema, intravenous or suppository preparations of corticosteroids, oral or intravenous ciclosporin, mesalazine enemas or suppositories within the past four weeks - Patients taking azathioprine or 6-mercaptopurine who have altered the dose or started treatment within the past three months, (these drugs permitted in stable dose during the study) - Patients with intolerance to Asacol 400 mg or mesalazine - Women who are pregnant or lactating - Patients with known HIV infection - Patients with hepatic disease - Patients with renal impairment (creatinine above local reference range), or with positive urine dipstick test to blood or protein - Other serious medical or psychiatric illness that in the opinion of the investigator would possibly comprise the study - Patients with problem alcohol excess or drug abuse | |
| 36 | NCT00523744 | completed | 1 | phase 3 | ['hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['amlodipine', 'olmesartan medoxomil', 'amlodipine+valsartan', 'hydrochlorothiazide'] | ['COC(=O)C1=C(C)NC(C)=C(C1C1=CC(=CC=C1)[N+]([O-])=O)C(=O)OC(C)(C)CN(C)CCC(C1=CC=CC=C1)C1=CC=CC=C1', 'CCCC1=NC(=C(N1CC1=CC=C(C=C1)C1=C(C=CC=C1)C1=NN=NN1)C(O)=O)C(C)(C)O', 'CCCCC(=O)N(CC1=CC=C(C=C1)C1=CC=CC=C1C1=NNN=N1)[C@@H](C(C)C)C(O)=O', 'COCCC1=CC=C(OCC(O)CNC(C)C)C=C1'] | Inclusion Criteria for Core study: - Male or female patients (>=18 years) - Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods - Patients with essential hypertension (diastolic blood pressure >=100 mmHg and <110 mmHg) Inclusion Criteria for Extension: - Patients had to have a msSBP >= 140 mmHg and/or msDBP >= 90 mmHg at week 8 ie, end of core study. Exclusion Criteria for Core study: - Severe hypertension (diastolic blood pressure >=110 mmHg or systolic blood pressure >= 180 mmHg) - Pregnant or nursing women - Treated hypertensive patients with controlled hypertension under current therapy - A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV Exclusion Criteria for Extension: - prematurely discontinued the core study - failed to comply with the core study protocol Other protocol-defined inclusion/exclusion criteria applied to the study. | |
| 37 | NCT00143520 | completed | 1 | phase 2/phase 3 | ['type 2 diabetes'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['rivoglitazone', 'pioglitazone', 'placebo'] | ['COC1=CC=C2N=C(COC3=CC=C(CC4SC(=O)NC4=O)C=C3)N(C)C2=C1', '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'] | Inclusion Criteria: - Type 2 diabetes in male or female patients - Between 18 and 75 years of age - With a HbA1c greater than or equal to 7.5% and less than 10.5% at randomization Exclusion Criteria: - Type 1 diabetics or type 2 diabetics currently on insulin therapy - Patients unwilling or unable to discontinue their anti-diabetic medication(s) - History of ketoacidosis - History of therapy with rosiglitazone, troglitazone, pioglitazone | |
| 38 | NCT02486354 | completed | 1 | phase 3 | ['non-small cell lung cancer'] | ["['C78.00', 'C78.01', 'C78.02', 'D14.30', 'D14.31', 'D14.32', 'C34.2']"] | ['icotinib'] | ['C#CC1=CC=CC(NC2=NC=NC3=CC4=C(OCCOCCOCCO4)C=C23)=C1'] | Inclusion Criteria: - Histologically or cytologically confirmed locally advanced/metastatic (stage IIIB/stage IV, using the American Joint Committee on Cancer [AJCC] 6th edition of tumor-node-metastasis [TNM] staging system) NSCLC patients - Progressed after at least one platinum-based chemotherapy regimen at entry - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 - At least one measurable lesion by Response Evaluation Criteria in Solid Tumors version 1.0 - Adequate hematologic and biochemical values Exclusion Criteria: - Patients with symptomatic brain metastases - Malignant tumor within the previous five years - Severe infection; congestive heart failure - Previous treatment with drugs targeting EGFR - History of interstitial lung disease | |
| 39 | NCT00421434 | completed | 1 | phase 2/phase 3 | ['chronic hepatitis c'] | ["['B18.2', 'B18.0', 'B18.1', 'B18.8', 'B18.9', 'K71.3', 'K71.4']"] | ['nitazoxanide', 'ribavirin', 'ribavirin'] | ['CC(=O)OC1=CC=CC=C1C(=O)NC1=NC=C(S1)[N+]([O-])=O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O', 'NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O'] | Inclusion Criteria: - Age ≥18 years. - Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme immunoassay for anti-HCV-antibodies and a positive quantitative RT-PCR amplification of HCV RNA. - Chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral hepatitis. - HCV genotype 4. Exclusion Criteria: - Patients who have previously failed to respond to ≥12 weeks of peginterferon-ribavirin combination therapy. - Females who are either pregnant, breast-feeding or not using birth control and are sexually active. - Males whose female partners are pregnant. - Patients with other causes of liver disease (i.e., autoimmune hepatitis, decompensated liver disease). - Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus. - Patients with a history of alcoholism or with an alcohol consumption of >40 grams per day. - Patients with hemoglobinopathies (i.e., thalassemia major, sickle-cell anemia). - Patients with any concomitant condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed. - History of hypersensitivity or intolerance to any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectionable solution or ribavirin tablets. | |
| 40 | NCT00141011 | terminated | futility | 0 | phase 3 | ['stroke', 'cerebral ischemia', 'brain infarction'] | ["['G46.4', 'G46.3', 'Z82.3']", "['P91.821', 'P91.822']"] | ['ancrod (viprinex)', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Acute, ischemic stroke with first symptoms within 6 hours of beginning treatment - Baseline NIHSS > 5 Exclusion Criteria: - No intracranial, extravascular blood on CT - Hypertension (systolic > 185; diastolic > 105) - Baseline fibrinogen level < 100 mg/dL - Thrombocytopenia (< 100,000 / mm3) - Recent (< 3 days) or anticipated (< 5 days) use of a thrombolytic agent - Recent (< 14 days) or anticipated surgery |
| 41 | NCT01270347 | completed | 1 | phase 3 | ['cystic fibrosis'] | ["['E84.9', 'Z14.1', 'E84.0', 'E84.11', 'E84.8', 'E84.19', 'P09.4']"] | ['mp-376 (levofloxacin solution for inhalation)', 'tis (tobramycin inhalation solution)'] | ['C[C@H]1COC2=C3N1C=C(C(O)=O)C(=O)C3=CC(F)=C2N1CCN(C)CC1', 'NC[C@H]1O[C@H](O[C@@H]2[C@@H](N)C[C@@H](N)[C@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H]2O)[C@H](N)C[C@@H]1O'] | Inclusion Criteria (selected): - > 12 years of age - Confirmed Diagnosis of Cystic Fibrosis - Positive sputum culture for P. aeruginosa within the past 12 months - Patients are able to elicit an FEV1 >/= 25% but </= 85% of predicted value at screening - Have received at least 3 courses of inhaled tobramycin over the preceding 12 months - Clinically stable with no changes in health status within the last 28 days - Able to reproducibly produce sputum and perform spirometry Exclusion Criteria (selected): - Use of any nebulized or systemic antibiotics within 28 days prior to baseline - History of hypersensitivity to fluoroquinolones or inhaled or systemic aminoglycosides including tobramycin or any excipients - Evidence of acute upper within 10 days or lower respiratory infections within 28 days prior to dosing - CrCl < 20 at Screening - History of lung transplantation Extension Portion of the Study: Patients enrolled in Mpex 209 are permitted to participate in the open label extension as long as they complete Visit 7 (Day 168), provide informed consent for participation in the open label extension of in the study and are clinically stable, as assessed by the Investigator. | |
| 42 | NCT00005047 | terminated | accrual was halted on the basis of the data and safety monitoring board review of a futility analysis. | 0 | phase 3 | ['bladder cancer'] | ["['D30.3', 'C67.5', 'C67.9', 'C79.11', 'C67.0', 'C67.1', 'D41.4']"] | ['cisplatin', 'doxorubicin hydrochloride', 'methotrexate', 'vinblastine'] | ['[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', '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', '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', 'N[C@@H](CCCNC(N)=N)C(O)=O'] | DISEASE CHARACTERISTICS: - Histologically proven organ confined transitional cell carcinoma (TCC) of the bladder - Must have undergone radical cystectomy and bilateral pelvic lymphadenectomy with pathologic stage from definitive cystectomy specimen of P1, P2a, or P2b and N0, M0 TCC with or without squamous/glandular differentiation (no adenocarcinoma, squamous cell carcinoma, or small cell carcinoma) - Margins must be negative for invasive or in situ TCC - In situ TCC in the urethra or ureter(s) allowed provided margins are negative - Clinical stage T1, T2a, or T2b based on transurethral resection bladder tumor specimen with P0 or PIS and N0, M0 TCC allowed - Incidental pT2a (Gleason score no greater than 7), pT2b (Gleason score no greater than 7), or pT2c (Gleason score no greater than 7) adenocarcinoma of the prostate allowed - No invasive tumor into ureter(s) or urethra - Must have potentially curable disease - Must register within 9 weeks after surgery - No metastatic disease by physical exam and chest x-ray or CT scan of the chest - Eligible for randomization if: - p53 gene alteration present - Randomization occurs within 10 weeks after surgery - Those who are randomized to receive (MVAC) methotrexate, vinblastine, doxorubicin, and cisplatin begin MVAC within 12 weeks after cystectomy - No metastatic disease by physical exam and chest x-ray or CT scan of the chest - No prohibitive medical risk for chemotherapy PATIENT CHARACTERISTICS: Age - Any age Performance status - ECOG 0-1 OR - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - WBC at least 4,000/mm^3 - Platelet count at least 150,000/mm^3 Hepatic - SGOT or SGPT no greater than 2 times normal - Alkaline phosphatase no greater than 2 times normal - Bilirubin normal Renal - Creatinine no greater than 1.8 mg/dL OR - Creatinine clearance at least 50 mL/min - Blood urea nitrogen normal Cardiovascular - No serious arrhythmias - No congestive heart disease with New York Heart Association class III or IV status - Randomization group: - Ejection fraction must be at least 50% by MUGA scan if there is a clinical concern regarding the patient's cardiac status Other - No other malignancy (including synchronous papillary or invasive upper urinary tract malignancy) within the past 5 years except incidental prostate cancer (found at cystectomy), basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix - No concurrent advanced medical illness or psychologic disease - No prohibitive medical risk for chemotherapy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No prior systemic chemotherapy for bladder cancer - At least 5 years since other prior systemic chemotherapy - Prior intravesical therapy allowed - Randomization group: - Prior intravesical therapy allowed if administered prior to cystectomy Endocrine therapy - Not specified Radiotherapy - No prior pelvic irradiation Surgery - See Disease Characteristics |
| 43 | NCT00316082 | completed | 1 | phase 3 | ['diabetes'] | ["['E23.2', 'N25.1', 'P70.2', 'O24.92', 'Z83.3', 'Z86.32', 'E10.65']"] | ['saxagliptin', 'saxagliptin', 'saxagliptin', 'saxagliptin', 'placebo', 'metformin'] | ['N[C@H](C(=O)N1[C@H]2C[C@H]2C[C@H]1C#N)C12CC3CC(CC(O)(C3)C1)C2', 'N[C@H](C(=O)N1[C@H]2C[C@H]2C[C@H]1C#N)C12CC3CC(CC(O)(C3)C1)C2', 'N[C@H](C(=O)N1[C@H]2C[C@H]2C[C@H]1C#N)C12CC3CC(CC(O)(C3)C1)C2', 'N[C@H](C(=O)N1[C@H]2C[C@H]2C[C@H]1C#N)C12CC3CC(CC(O)(C3)C1)C2', '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'] | Inclusion Criteria: - Type 2 diabetes - Inadequate blood sugar control Exclusion Criteria: - Previous treatment for diabetes - Current treatment with other medications to lower blood sugar - Major heart, liver or kidney problems - Women who are pregnant or breastfeeding | |
| 44 | NCT00388973 | completed | 1 | phase 3 | ['major depressive disorder'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['quetiapine'] | ['OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12'] | Inclusion Criteria: - Male or female patients, 66 years or older, with a documented clinical diagnosis of MDD. Exclusion Criteria: - The presence of dementia or mental disorder other than MDD within 6 months of enrolment, - Uncontrolled hypertension, substance or alcohol abuse - A current diagnosis of cancer or a current or past diagnosis of stroke | |
| 45 | NCT00095238 | completed | 0 | phase 3 | ['congestive heart failure'] | ["['I50.20', 'I50.21', 'I50.22', 'I50.30', 'I50.31', 'I50.32', 'I50.40']"] | ['irbesartan', 'placebo'] | ['CCCCC1=NC(Cl)=C(CO)N1CC1=CC=C(C=C1)C1=CC=CC=C1C1=NNN=N1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Male or female age >= 60 years with current symptoms of heart failure consistent with New York Heart Association (NYHA) class II-IV - Left ventricular ejection fraction (LVEF) > = 45% - Willing to provide written informed consent AND hospitalization for heart failure within the past 6 months OR various abnormalities in electrocardiogram, echocardiogram or chest x-ray indicating heart disease. Exclusion Criteria: - Acute myocardial infarction within 3 months; - Heart revascularization procedure within 3 months; - Hospitalization for angina within 3 months; - Other heart surgery - Life-threatening or uncontrolled arrhythmia - Subjects with an implantable cardioverter-defibrillator that has discharged in the past 3 months; - Stroke or surgery of the arteries in the brain within 3 months; - Serious lung disease which requires use of home oxygen. - Significantly low blood pressure - Significantly high blood pressure - Other known diseases that may limit life expectancy to <3 years; - Known or suspected bilateral kidney artery narrowing; - Geographic or social factors making study participation and follow-up impractical. | |
| 46 | NCT00389207 | completed | 1 | phase 3 | ['hiv infections'] | ["['Z21']"] | ['nevirapine bid', 'nevirapine qd', 'atazanavir'] | ['CC1=C2NC(=O)C3=C(N=CC=C3)N(C3CC3)C2=NC=C1', 'CC1=C2NC(=O)C3=C(N=CC=C3)N(C3CC3)C2=NC=C1', 'CC(C)[C@H](NC(=O)N(C)CC1=CSC(=N1)C(C)C)C(=O)N[C@H](C[C@H](O)[C@H](CC1=CC=CC=C1)NC(=O)OCC1=CN=CS1)CC1=CC=CC=C1'] | Inclusion criteria: Inclusion Criteria: 1. Signed informed consent in accordance with Good Clinical Practice (GCP) and local regulatory requirements prior to trial participation 2. HIV-1-infected males or females >= 18 years of age with positive serology confirmed by Western blot 3. No previous antiretroviral treatment (of more than 7 days) 4. Males with CD4+ counts of < 400 cells/mm3 and females with CD4+ counts of < 250 cells/mm3 5. NVP- and ATZ/r susceptibility based on HIV-1 genotypic resistance report 6. Adequate renal function defined as a calculated creatinine clearance (CLCr) >= 50 ml/min according to the Cockcroft-Gault formula 7. Karnofsky score >= 70 8. Acceptable medical history, as assessed by the investigator Exclusion criteria: Exclusion Criteria: 1. Active drug abuse or chronic alcoholism at the investigator's discretion 2. Hepatic cirrhosis stage Child-Pugh B or C 3. Female patients of child-bearing potential who: - have a positive serum pregnancy test at screening or during the study, - are breast feeding, - are planning to become pregnant, - are not willing to use a barrier method of contraception, or are not willing to use methods of contraception other than ethinyl estradiol containing oral contraceptives 4. Laboratory parameters Division of Acquired Immunodeficiency Syndrome (DAIDS) > grade 2 (triglycerides > DAIDS grade 3; total cholesterol no restrictions) 5. Active hepatitis B or C disease, defined as HBsAg-positive or Hepatitis C-Virus-Ribo Nucleic Acid (HCV-RNA)- positive with Aspartate Transaminase/Alanine Transaminase (AST/ALT) > 2.5x Upper Limit of Normal (ULN) (DAIDS grade 1) 6. Hypersensitivity to any ingredients of the test products 7. Have therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, pentamidine, tacrolimus, cyclosporine) or potential competitors of renal excretion (e.g., cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, probenecid, high-dose non-steroidal anti-inflammatory drugs (i.e., ibuprofen)) within 3 months prior to study screening or are expected to receive these during the study 8. Patients who are receiving other concomitant treatments which are not permitted 9. Use of other investigational medications within 30 days before study entry or during the trial 10. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2, chronic treatment with prednisone) 11. Patients with Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any lymphoma 12. Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit 13. Patients who are receiving systemic treatment for malignant disease | |
| 47 | NCT00599027 | completed | 1 | phase 3 | ['allergic rhinitis', 'asthma'] | ["['J30.89', 'J30.9', 'J30.2', 'J30.1', 'J30.5', 'J30.81']", "['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['mometasone furoate nasal spray (mfns)', 'placebo nasal spray'] | ['[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: - Outpatients (≥18 and ≤ 75 years of age) of either sex - Willingness to participate and comply with procedures by signing a written informed consent - Moderate/severe persistent allergic rhinitis with a history of intermittent asthma from at least 2 years and actual asthma (symptoms in the last 4 weeks) - To qualify at the randomization visit the daily average of the T5SS [(Morning-time T5SS + Evening-time T5SS)/2] had to be ≥ 6 in at least 4 days during the 1 week run-in period - Positive (weal diameter >3 mm) skin prick test (SPT) and/or CAP-RAST (class II or higher) performed in the 6 months prior to the start of the trial were required for at least house dust mite and 1 pollen allergen (grass or Parietaria, IgE level >3.5 U/mL) - All prior medication washout times had been observed - Female volunteers of childbearing potential had to agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication - Negative urine pregnancy test - Free of any clinically relevant disease that would have interfered with study evaluations - Able to adhere to the dosing and visit schedules, and agree to record symptom severity scores and use of IMP and rescue medications in a daily diary Exclusion Criteria: - Female who was or intended to become pregnant during the study or within 12 weeks after study completion - Nursing, or intended to be nursing during the study or within 12 months after study completion - Taking medications prohibited during the study or had not complied with the requirements for the designated washout periods for any of the prohibited medications - Anatomical abnormalities of the nose (turbinate hypertrophy, septal deviation, polyps) - Acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral decongestants - Rhinitis medicamentosa - Evidence of persistent asthma, or asthma with daytime and nighttime symptoms not controlled by short-acting beta2-adrenoceptor agonists - Asthma requiring chronic use of inhaled or systemic corticosteroids - Upper respiratory tract or sinus infection that required antibiotic therapy and had not had at least a 14-day wash-out period prior to the run-in period, or had a viral upper respiratory infection within 7 days prior to screening - Dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids - Undergoing a progressive course of immunotherapy (hyposensitization). Subjects on a regular maintenance schedule prior to the screening visit were eligible for study inclusion; however, subject could not receive hyposensitization treatment within 24 hours prior to any study visit - Diagnosed of cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas) - Concomitant medical problem - Had any of the following clinical conditions: active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, systemic viral infections or ocular herpes simplex - Smoked or had smoked within the previous 6 months - Member of the staff, affiliated with, or family member of the staff personnel directly involved with this study - Previously randomized into this study - Any other clinically significant deviation from normal in the physical examination or medical history that could interfere with the study evaluation or affect subject safety - In a situation or condition that could interfere with participation in the study - Used any drug or device in an investigational protocol in the 30 days prior to visit 1 - Participating in other clinical studies - Allergic or has sensitivity to the study drug or its excipients - Compromised ability to provide informed consent - History of non-compliance with medication or treatment protocols | |
| 48 | NCT01028391 | 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 45 mg q.d.', 'pioglitazone 45 mg q.d. + sitagliptin 100 mg placebo q.d.', 'metformin'] | ['N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F', 'N[C@@H](CCCNC(N)=N)C(O)=O', 'CSCC[C@H](N)C(O)=O'] | Inclusion Criteria: - Patients must complete the double-blind base study (MK-0431-064-00)(NCT00397631) and have at least 75% compliance with study medication during the base study treatment period. - Women of childbearing potential must continue to comply with the protocol-specified contraceptive methods | |
| 49 | NCT00120523 | completed | 1 | phase 3 | ['atopic dermatitis'] | ["['L20.89', 'L20.9']"] | ['pimecrolimus', 'topical corticosteroids'] | ['[H][C@]1(CC[C@H](Cl)[C@@H](C1)OC)\\C=C(/C)[C@@]1([H])OC(=O)[C@]2([H])CCCCN2C(=O)C(=O)[C@]2(O)O[C@@]([H])([C@H](C[C@H]2C)OC)[C@H](C[C@@H](C)C\\C(C)=C\\[C@@H](CC)C(=O)C[C@H](O)[C@H]1C)OC', '[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'] | Inclusion Criteria: - Aged 3 to < 12 months - Diagnosis of AD fulfilling the diagnostic criteria of Seymour - AD affecting at least 5% total body surface area - Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline - Informed consent Exclusion Criteria: - Phototherapy, systemic therapy (e.g., immunosuppressants, cytostatics), systemic corticosteroids within 4 weeks - Topical tacrolimus or pimecrolimus within 2 weeks - Topical therapy (e.g., tar, topical corticosteroids) within 3 days - Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease - Active acute viral skin infection (e.g. herpes simplex, herpes zoster, chicken pox), and/or clinically infected AD - Failure to thrive (e.g., weight or height/length below the 5th percentile) or developmental abnormalities such as head circumference less than 5th and more than 95th percentile - Known hypersensitivity to any ingredient of pimecrolimus cream 1% or topical corticosteroids - Clinical conditions other than AD that according to investigator can interfere with the evaluation | |
| 50 | NCT00432458 | completed | 0 | phase 3 | ['multiple myeloma and plasma cell neoplasm'] | ["['C96.20', 'C96.29', 'D47.09']"] | ['thalidomide', 'zoledronic acid'] | ['CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2', 'OC(CN1C=CN=C1)(P(O)(O)=O)P(O)(O)=O'] | DISEASE CHARACTERISTICS: - Diagnosis of multiple myeloma (MM) - Previously untreated asymptomatic disease - No requirement for immediate chemotherapy for active MM, such as hypercalcemia from myeloma or painful bone lesions - No solitary plasmacytoma - Measurable or evaluable disease as defined by one of the following: - Serum monoclonal protein ≥ 1.0 g by protein electrophoresis - More than 200 mg of monoclonal protein in the urine by 24-hour electrophoresis - Measurable soft tissue plasmacytoma by physical exam with ruler or by MRI or positron emission tomography/CT scan - If the only measurable lesion is the plasmacytoma, it must be ≥ 1.5 cm in 1 dimension - Must have ≥ 10% plasma cells as measured on the bone marrow aspirate, bone marrow biopsy, or labeling index - No amyloidosis PATIENT CHARACTERISTICS: - Performance status 0-2 - Absolute neutrophil count ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Hemoglobin ≥ 8.0 g/dL - Creatinine ≤ 2.0 mg/dL (elevation above normal range should not be felt to be related to myeloma) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and for 4 weeks after completion of study treatment - No uncontrolled infection - No other active malignancy - No New York Heart Association class III or IV heart disease - No pre-existing neuropathy ≥ grade 2 - No concurrent major dental work PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Prior corticosteroids (for nonmalignant disorders) allowed - Prior therapy with experimental agents not shown to have significant activity in MM, such as clarithromycin, dehydroepiandrosterone, and anakinra allowed - No prior thalidomide or corticosteroids for MM - No more than 3 doses of IV zoledronate or pamidronate within the past 12 months - At least 3 months since prior radiotherapy, including radiotherapy for solitary plasmacytoma - No concurrent oral bisphosphonate therapy for osteoporosis | |
| 51 | NCT00515632 | completed | 1 | phase 3 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['balaglitazone'] | ['CN1C(COC2=CC=C(CC3SC(=O)NC3=O)C=C2)=NC2=CC=CC=C2C1=O'] | Inclusion Criteria: 1. Type 2 diabetes mellitus, being diagnosed according to the 1999 WHO criteria for at least 3 months 2. Age ≥ 18 years 3. BMI ≥ 25.0 kg/m2 4. HbA1c ≥ 7.0 % 5. Treatment with insulin with stable dose of at least 30 U/day (± 4 U/day), for at least 75 days Exclusion Criteria: 1. Prior or current use of any PPAR-γ agonist 2. Recent use (< 3 months) of an investigational drug 3. Pre-existing medical condition judged to preclude safe participation in the study 4. Contraindication/intolerance to study medication 5. Use of any drug which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids) 6. Diagnosed or receiving medication for heart failure, NYHA I to IV 7. Hospitalisation for a major CV event in the last 3 months, scheduled major CV intervention 8. Uncontrolled treated/untreated systolic blood pressure >180 mmHg and/or diastolic blood pressure > 95 mmHg 9. Known diabetic macular oedema 10. Hematuria 11. Serum creatinine >130 μmol/l 12. ALT, AST, total bilirubin or alkaline phosphatase ≥ 2.5 times the upper limit of normal 13. Haemoglobin significantly (in the Investigators opinion, but not more than 1 mmol/L) below the lower limit of normal or haemoglobinopathy interfering with valid HbA1c assay 14. Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods (adequate contraceptive measures are an intrauterine device or oral contraceptives) 15. Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation 16. Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocols 17. Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial | |
| 52 | NCT00316719 | completed | 1 | phase 3 | ['chronic hepatitis b'] | ["['B18.0', 'B18.1', 'B18.2', 'B18.8', 'B18.9']"] | ['lam group', 'adv group'] | ['NC1=NC(=O)N(C=C1)[C@@H]1CS[C@H](CO)O1', 'CC(C)(C)C(=O)OCOP(=O)(COCCN1C=NC2=C(N)N=CN=C12)OCOC(=O)C(C)(C)C'] | Inclusion criteria: - Have compensated chronic hepatitis B. - Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted. - Ability to read, understand, and sign the informed consent. - Have a positive serum HBV-DNA >= 1,000,000 copies/mL and ALT level 50-500 U/L Exclusion criteria: - Having or suspected of having liver cancer. - Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV). - Autoimmune hepatitis. - Received any previous transplantation or having a plan for any transplantation. - Existence of any serious complication, except hepatitis B. | |
| 53 | NCT01460342 | completed | 1 | phase 3 | ['benign prostatic hyperplasia'] | ["['N40.0', 'N40.1']"] | ['tadalafil', 'placebo'] | ['[H][C@]12CC3=C(NC4=CC=CC=C34)[C@H](N1C(=O)CN(C)C2=O)C1=CC2=C(OCO2)C=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Present with benign prostatic hyperplasia (BPH; also referred to as BPH-LUTS), based on the disease diagnostic criteria, at study entry. - Provide signed informed consent at study entry. - Have BPH-LUTS with a Total International Prostate Symptom Score (IPSS) of ≥13 at beginning of placebo lead-in period. - Have bladder outlet obstruction of intermediate severity as defined by a urinary peak flow rate (Qmax) of ≥4 to ≤15 milliliters per second (mL/sec) [from a prevoid total bladder volume (assessed by ultrasound) of ≥150 to ≤550 milliliters (mL) and a minimum voided volume of 125 mL] at beginning of placebo lead-in period. - Have prostate volume ≥20 mL estimated by transabdominal or transrectal ultrasound at study entry. - Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and/or overactive bladder (OAB) treatments, including alpha-blockers, 5-alpha reductase inhibitors (5-ARIs), phosphodiesterase type 5 (PDE5) inhibitors, or herbal preparations at any time during the study. - Have not taken the following treatments within the indicated duration: - Finasteride therapy for at least 3 months prior to beginning of placebo lead-in period. - Dutasteride therapy for at least 6 months prior to beginning of placebo lead-in period. - Anti-androgenic hormone therapy at least 12 months prior to beginning of placebo lead-in period. - All other BPH therapy (including herbal preparations) for at least 4 weeks prior to beginning of placebo lead-in period. - ED therapy for at least 4 weeks prior to beginning of placebo lead-in period. - OAB therapy for at least 4 weeks prior to beginning of placebo lead-in period. - Demonstrate compliance with study drug administration requirements during the placebo lead-in period by administering ≥70% of prescribed doses, confirmed by documentation that the participant returned ≤30% of prescribed doses at randomization. Exclusion Criteria: - Prostate-specific antigen (PSA) >10.0 nanograms per milliliter (ng/mL) at study entry. - PSA ≥4.0 to ≤10.0 ng/mL at study entry, if prostate malignancy has not been ruled out to the satisfaction of an urologist. - Bladder postvoid residual (PVR) ≥300 mL by ultrasound determination at study entry. - History of any of the following pelvic conditions (checked at study entry): - Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or bowel resection. - Pelvic radiotherapy. - Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery. - Lower urinary tract malignancy or trauma. - Lower urinary tract instrumentation (including prostate biopsy) within 30 day of study entry. - History of urinary retention or lower urinary tract (bladder) stones within 6 months of study entry. - History of urethral obstruction due to stricture, valves, sclerosis, or tumor. - Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis) at study entry. - Clinical evidence of prostate cancer. - Clinical evidence of any of the following bladder conditions: - Mullerian duct cysts. - Atonic, decompensated, or hypocontractile bladder. - Detrusor-sphincter dyssynergia (contraction of the detrusor without sphincter relaxation). - Intravesical obstruction (for example, intravesical median lobe of the prostate). - Interstitial cystitis. - Clinical evidence of any of the following urinary tract conditions at study entry: - Urinary tract infection. - Urinary tract inflammation (including prostatitis). Urinary tract infection/inflammation is defined as a positive result for leukocyte esterase from a urine dipstick or >5 white blood cells (WBCs) per high-powered field on urinalysis from a centrifuged, clean-catch, midstream urine specimen. - Current antibiotic therapy for urinary tract infection. - Clinically significant microscopic hematuria as determined by an urologist. - History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance <30 milliliters per minute (mL/min) at study entry, as calculated by the central laboratory using the Cockcroft-Gault formula. - Clinical evidence of severe hepatic impairment [aspartate transaminase (AST) or alanine transaminase (ALT) >3-fold of the upper limit of normal range] at study entry. - History of any of the following cardiac conditions (checked at study entry): - Angina requiring treatment with long-acting nitrates. - Angina requiring treatment with short-acting nitrates within 90 days of study entry. - Unstable angina within 90 days of study entry. - Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention. - History of any of the following coronary conditions within 90 days of study entry: - Myocardial infarction. - Coronary artery bypass graft surgery. - Percutaneous coronary intervention (for example, angioplasty or stent placement). - Any evidence of heart disease [New York Heart Association (NYHA) ≥Class III] within 6 months of study entry. - Systolic blood pressure >160 or <90 millimeters of mercury (mm Hg) or diastolic blood pressure >100 or <50 mm Hg at study entry (if stress is suspected, retest under basal conditions), or malignant hypertension. - Glycosylated hemoglobin (HbA1c) >9% at study entry. - Scheduled or planned surgery (or any procedure requiring general, spinal, or epidural anesthesia) during the course of the study. - History of significant central nervous system injuries (including stroke or spinal cord injury) within 6 months of study entry. - History of drug, alcohol, or substance abuse within 6 months of study entry. - Current treatment with nitrates, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone agonists/antagonists, or anabolic steroids at study entry. - Current systemic treatment with any of the following: - Potent cytochrome P450 3A4 (CYP3A4) inhibitors, such as ketoconazole or ritonavir. - CYP3A4 inducers such as rifampicin. - Known or suspected to be hypersensitive to tadalafil, or any study drug components. - Any conditions that would interfere with a participant's ability to provide informed consent or comply with study instructions, would place participant at increased risk, or might confound the interpretation of the study results. - Previously completed or withdrawn from this study or any other study investigating tadalafil. - Received treatment within the last 30 days with a drug or device that has not received regulatory approval for any indications at the time of informed consent. Participants who have been screen failures in previous studies may be eligible. | |
| 54 | NCT00424190 | completed | 1 | phase 3 | ['bacterial infections'] | ["['A49.9', 'A04.9', 'A04.8', 'A49.8']"] | ['iv vancomycin plus iv aztreonam', 'ceftaroline'] | ['CN[C@H](CC(C)C)C(=O)N[C@@H]1[C@H](O)C2=CC=C(OC3=C(O[C@@H]4O[C@H](CO)[C@@H](O)[C@H](O)[C@H]4O[C@H]4C[C@](C)(N)[C@H](O)[C@H](C)O4)C4=CC(=C3)[C@@H](NC(=O)[C@H](CC(N)=O)NC1=O)C(=O)N[C@@H]1C3=CC(=C(O)C=C3)C3=C(O)C=C(O)C=C3[C@H](NC(=O)[C@@H](NC1=O)[C@H](O)C1=CC(Cl)=C(O4)C=C1)C(O)=O)C(Cl)=C2', '[H][C@]12SCC(SC3=NC(=CS3)C3=CC=[N+](C)C=C3)=C(N1C(=O)[C@H]2NC(=O)C(=N/OCC)\\C1=NSC(NP(O)(O)=O)=N1)C([O-])=O'] | Inclusion Criteria: - Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease. Exclusion Criteria: - Prior treatment of current cSSSI with an antimicrobial. - Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam. | |
| 55 | NCT00219544 | completed | 1 | phase 3 | ['neuropathic pain'] | ["['E85.1', 'E85.0', 'N31.0', 'N31.1', 'N31.2', 'E10.610', 'E11.610']"] | ['pregabalin (lyrica)', 'pregabalin (lyrica)', 'pregabalin (lyrica)', 'placebo'] | ['CC(C)C[C@H](CN)CC(O)=O', 'CC(C)C[C@H](CN)CC(O)=O', 'CC(C)C[C@H](CN)CC(O)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Subjects presenting a diagnosis of peripheral neuropathic pain, defined as pain caused by a lesion of the peripheral nervous system manifesting with sensory symptoms and signs, for at least 6 months at screening. - At baseline, subjects must have completed at least 4 daily pain diaries and must have a mean weekly pain score equal or greater than 4. Exclusion Criteria: - Presence of any of the following diagnoses: Cervical or lumbo-sacral radiculopathy; Operated or non-operated chronic low back pain Carpal tunnel syndrome or any other entrapment-related neuropathic pain (defined as pain associated with focal nerve lesion produced by constriction or mechanical distortion of the nerve, within a fibrous or fibro-osseous tunnel, or by a fibrous band) ; Complex regional pain syndrome (type 1 and 2); Fibromyalgia. | |
| 56 | NCT00146523 | completed | 0 | phase 3 | ['major depressive disorder'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['mifepristone', 'placebo'] | ['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', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Are 18 to 75 years of age - Have a diagnosis of major depressive disorder with psychotic features (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM IV] 296.24 or 296.34) - Are able to provide written informed consent. Exclusion Criteria: - Have a major medical problem - Have previously participated in a Corlux (C-1073, mifepristone) clinical trial - Have a history of an allergic reaction to Corlux (C-1073, mifepristone). | |
| 57 | NCT01445678 | completed | 1 | phase 3 | ['complicated intra-abdominal infection'] | ["['D18.03', 'C83.73', 'C84.03', 'C84.13', 'C81.73', 'C81.93', 'C82.93']"] | ['cxa-201 and metronidazole', 'meropenem'] | ['CC1=NC=C(N1CCO)[N+]([O-])=O', 'CN(C)CCOC(C)(C1=CC=CC=C1)C1=CC=CC=N1'] | Inclusion Criteria: - Diagnoses of cIAI. - Subject requires surgical intervention (e.g., laparotomy, laparoscopic surgery, or percutaneous draining of an abscess) within 24 hours of (before or after) the first dose of study drug. Exclusion Criteria: - Simple appendicitis; acute suppurative cholangitis; infected necrotizing pancreatitis; pancreatic abscess; or pelvic infections. - Complicated intraabdominal infection managed by staged abdominal repair (STAR), open abdomen technique including temporary closure of the abdomen, or any situation where infection source control is not likely to be achieved. - Use of systemic antibiotic therapy for IAI for more than 24 hours prior to the first dose of study drug, unless there is a documented treatment failure with such therapy. - Have a concomitant infection at the time of randomization, which requires non-study systemic antibacterial therapy in addition to IV study drug therapy. (Drugs with only gram-positive activity [e.g., daptomycin, vancomycin, linezolid] are allowed). - Severe impairment of renal function (estimated CrCl < 30 mL/min), or requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20 mL/h urine output over 24 hours). - The presence of hepatic disease at baseline. - Considered unlikely to survive the 4 to 5 week study period. - Any rapidly-progressing disease or immediately life-threatening illness (including respiratory failure and septic shock). - Have a documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibacterial (a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment), including cephalosporins, carbapenems, penicillins, or ß-lactamase inhibitors, or metronidazole, or nitroimidazole derivatives. - Women who are pregnant or nursing. | |
| 58 | NCT00471445 | completed | 1 | phase 3 | ['neurotoxicity', 'pain', 'peripheral neuropathy', 'unspecified adult solid tumor, protocol specific'] | ["['G92.00', 'G92.01', 'G92.02', 'G92.03', 'G92.04', 'G92.05']", "['N50.82', 'R07.2', 'R07.82', 'R10.13', 'R10.33', 'R14.1', 'R52']", "['G90.09']", "['H01.009', 'H02.209', 'H02.009', 'H02.109', 'H04.209', 'H05.409', 'H10.509']"] | ['ketamine/amitriptyline np-h cream'] | ['CC1=CC(=C(NCCCN)C=C1)[N+]([O-])=O'] | DISEASE CHARACTERISTICS: - History of cancer - Pain, numbness, or tingling in the hands or feet beginning in association with a cancer chemotherapy agent (taxane or other chemotherapeutic agent) and persisting for at least 28 days following the conclusion of chemotherapy - Pain, numbness, or tingling can be assessed 28 days or more after the conclusion of chemotherapy - An average score of ≥ 4 for the 7 daily ratings of the baseline week on the 11-point rating scale of peripheral neuropathy associated with chemotherapy, with a minimum of 5 daily diary ratings completed during the baseline week - No preexisting or history of peripheral neuropathy due to any cause other than chemotherapy (e.g., hereditary, alcohol, or diabetes) - Patients with stable systemic metastases and/or bone involvement AND has not received chemotherapy within 3 months of screening assessment are eligible - Patients receiving ongoing treatment with non-chemotherapy agents (e.g., monoclonal antibodies or hormonal treatment) allowed - No concurrent active chemotherapy in the adjuvant setting or for progressive systemic disease PATIENT CHARACTERISTICS: - Karnofsky performance status 60-100% - Creatinine ≤ 2 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to adequately understand English - No allergy or hypersensitivity to ketamine hydrochloride or amitriptyline or any of the components of study drug - No clinically significant illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, or skeletal illness) that, in the investigator's clinical judgment, could interfere with the efficacy or safety assessments in this study - No glaucoma or recurrent urinary retention - No clinically significant depression or dementia that, in the opinion of the investigator, may interfere with a patient's adherence to the study protocol and/or the accurate and consistent reporting of CPN - No open skin lesions in the area where the cream is to be applied - No HIV positivity PRIOR CONCURRENT THERAPY: - See Disease Characteristics - At least 30 days since prior unapproved experimental drugs or biological agents - No prior topical treatment, nerve blocks, implantable therapy, peripheral nerve or spinal cord stimulation, or neurosurgical procedure for chemotherapy-related peripheral neuropathy (CPN) - No prior exposure to a peripheral neurotoxin other than chemotherapy - No concurrent medications (e.g., phenytoin) known to be associated with sensory neuropathy - No concurrent selective serotonin reuptake inhibitors (e.g., fluoxetine, paroxetine, or sertraline), which inhibit CP450 2D6, unless the patient is being treated for depression or another psychiatric disorder and, in the investigator's judgment, the patient's participation in the study can be permitted given the minimal systemic levels of amitriptyline found within the cream - No concurrent monoamine oxidase inhibitors, barbiturates, anticholinergic agents, or sympathomimetic drugs, including epinephrine combined with local anesthetics - Oral inhalers that include any of the drugs listed above are allowed - Concurrent opioid analgesics, tricyclic or dual reuptake inhibitor antidepressants, or gabapentin or pregabalin for CPN, or benzodiazepines for sleep allowed, provided dose has been stable for ≥ 2 weeks and the following are true: - Gabapentin dose ≤ 1,800 mg per day - Pregabalin dose ≤ 300 mg per day - Opioid analgesic dose ≤ 60 mg oxycodone hydrochloride equivalent per day - Tricyclic antidepressant dose ≤ 75 mg amitriptyline equivalent per day - Duloxetine dose ≤ 60 mg per day - Venlafaxine dose ≤ 150 mg per day - Tramadol dose ≤ 200 mg per day - Concurrent adjunctive analgesic therapy, such as acupuncture, biofeedback, or herbal preparations, allowed provided dose has been stable for ≥ 2 weeks | |
| 59 | NCT01357616 | completed | 1 | phase 3 | ['open-angle glaucoma', 'ocular hypertension'] | ["['H40.10X0', 'H40.10X1', 'H40.10X2', 'H40.10X3', 'H40.10X4', 'H40.1130', 'H40.1131']", "['H40.053', 'H40.051', 'H40.052', 'H40.059']"] | ['brinzolamide 1% / timolol 0.5% fixed combination ophthalmic suspension', 'brinzolamide 1% ophthalmic suspension', 'timolol 0.5% ophthalmic solution'] | ['[H][C@](O)(CNC(C)(C)C)COC1=NSN=C1N1CCOCC1', 'CCN[C@H]1CN(CCCOC)S(=O)(=O)C2=C1C=C(S2)S(N)(=O)=O', '[H][C@](O)(CNC(C)(C)C)COC1=NSN=C1N1CCOCC1'] | Inclusion Criteria: - Diagnosed with open angle glaucoma and/or ocular hypertension and not sufficiently responsive to monotherapy. - Meet qualifying IOP criteria in at least 1 eye, including 21-35 mmHg at the Eligibility visit. - Willing to sign an Informed Consent form. - Contact lens wearer who is willing to remove lenses before instillation of study medication and wait a minimum of 15 minutes following drug instillation before re-inserting the lenses. - Able to discontinue use of current IOP-lowering medications per the minimum washout period. - Other protocol-specific inclusion criteria may apply. Exclusion Criteria: - Women of childbearing potential if pregnant, test positive for pregnancy at Screening/Enrollment visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. - Diagnosed with any form of glaucoma other than open-angle glaucoma and/or ocular hypertension. - Diagnosed with severe central visual field loss in either eye. - History of chronic, recurrent, or severe ocular infection, inflammatory eye disease in either eye. - History of ocular trauma within the past 6 months in either eye. - Current ocular infection or ocular inflammation within the past 3 months in either eye. - Ocular laser surgery within the past 3 months. - Intraocular surgery within the past 3 months. - Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen, 0.60 logMAR or 0.25 decimal). - History of, or current clinically relevant or progressive retinal disease in either eye. - History of, or current other severe ocular pathology (including severe dry eye) in either eye, that would preclude the administration of a topical carbonic anhydrase inhibitor (CAI) or beta-blocker. - Any abnormality preventing reliable applanation tonometry. - History of, or current condition or disease that would preclude the safe administration of a topical beta blocker or topical beta-adrenergic blocking agent. - History of spontaneous or current hypoglycemia or uncontrolled diabetes. - History of severe or serious hypersensitivity to CAIs, beta-blockers, or to any components of the study medication. - Less than 30 days stable dosing regimen before the Screening Visit of any medications or substances administered by any route and used on a chronic basis that may have affected IOP. - Recent use of high-dose salicylate therapy. - Anticipated use of any additional topical or systemic ocular hypotensive medication during the study. - Not safely able to discontinue all glucocorticoid medications administered by any route. - Currently on therapy or have been on therapy with another investigational agent within 30 days prior to the Screening Visit. - History of, or current evidence of severe illness or any other conditions which would, in the opinion of the Investigator, make the subject unsuitable for the study. - Other protocol-specific exclusion criteria may apply. | |
| 60 | NCT01137812 | completed | 1 | phase 3 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['sitagliptin 100 mg', 'canagliflozin 300 mg', 'metformin', 'sulphonylurea'] | ['N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F', '[H][C@]1(O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O)C1=CC=C(C)C(CC2=CC=C(S2)C2=CC=C(F)C=C2)=C1', 'CSCC[C@H](N)C(O)=O'] | Inclusion Criteria: - All patients must have a diagnosis of T2DM and be currently treated with metformin and sulphonylurea - Patients in the study must have a HbA1c between >=7 and <=10.5% and a fasting plasma glucose (FPG) <300 mg/dL (16.7 mmol/L) Exclusion Criteria: - History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy - or a severe hypoglycemic episode within 6 months before screening | |
| 61 | NCT00118365 | completed | 1 | phase 3 | ['precancerous condition'] | ["['Y95', 'D69.9', 'J94.9', 'L53.9', 'G47.01', 'G47.14', 'P28.9']"] | ['eflornithine', 'sulindac'] | ['NCCC[C@@](N)(C(F)F)C(O)=O', 'CC1=C(CC(O)=O)C2=CC(F)=CC=C2\\C1=C/C1=CC=C(C=C1)S(C)=O'] | Criteria: - History of >= 1 surgically resected adenomatous polyp of the colon measuring >= 3 mm within the past 5 years - Screening colonoscopy performed within the past 6 months - All polyps must have been removed during colonoscopy, pathologically examined, and archived - No prior surgical resection removing > 40 cm of the colon - No personal or family history of familial polyposis or hereditary non-polyposis colon cancer - SWOG 0-1 - Bilirubin =< 2.0 mg/dL - AST and ALT =< 2 times normal - Creatinine =< 1.5 mg/dL - Urine protein =<, urine casts 0-3, urine WBC and RBC count 0-5 cells by urinalysis - No history of inflammatory bowel disease - No gastric or duodenal ulcers within the past 12 months - Gastric or duodenal ulcers that were adequately treated > 24 months ago are allowed - No symptomatic gastric or duodenal ulcers - Not pregnant or nursing - Negative pregnancy test - Must have regional geographic stability over the next 36 months - Pure tone audiometry evaluation normal - Patients with >= 20 dB of uncorrectable hearing loss (for age) of any 2 contiguous frequencies are not allowed - No invasive malignancy within the past 5 years except adequately treated nonmelanoma skin cancer, level I (or Breslow < 0.76 mm) cutaneous melanoma, Duke's A colon cancer, stage I cervical cancer, or stage 0 chronic lymphocytic leukemia - No severe metabolic disorder - No other significant acute or chronic disease that would preclude study participation - No history of abnormal wound healing or repair - No conditions that would confer risk of abnormal wound healing or repair - No history of allergy to NSAIDs or eflornithine - No concurrent chemotherapy - No concurrent corticosteroids on a regular or predictable intermittent basis - No concurrent radiotherapy - Concurrent calcium supplements (=< 1,000 mg/day) allowed - Concurrent lipid-lowering drugs (i.e., high-dose statins) allowed - No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) on a regular or predictable intermittent basis - Concurrent aspirin for cardiovascular prophylaxis (i.e., 81 mg/day) allowed - No concurrent anticoagulants on a regular or predictable intermittent basis - No concurrent treatment for gastric or duodenal ulcers | |
| 62 | NCT00718224 | completed | 0 | phase 3 | ['venous thromboembolism'] | ["['O88.22', 'O88.23', 'O88.211', 'O88.212', 'O88.213', 'O88.219']"] | ['semuloparin sodium', 'enoxaparin', 'placebo'] | ['\\N', '[H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Knee replacement surgery or revision of at least one component of a knee prosthesis implanted ≥ 6 months prior to study entry. Exclusion Criteria: - Any major orthopedic surgeries in the 3 months prior to study; - Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome; - Any contraindications to the performance of venography; - High risk of bleeding; - Know allergy to heparin, or enoxaparin, or pork products; - End stage renal disease or patient on dialysis. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. | |
| 63 | NCT00326144 | completed | 1 | phase 3 | ['major depressive disorder'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['quetiapine fumarate'] | ['OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12'] | Inclusion Criteria: - Patient is able to provide written informed consent before beginning any study related procedures - Patient has a documented clinical diagnosis of major depressive disorder - Patient is able to understand and comply with the requirements of the study, as judged by a study investigator Exclusion Criteria: - Patients with a history of non-compliance as judged by the study investigator - Patients with a known lack of response to previous treatment with quetiapine - Patients who have participated in a clinical trial within 4 weeks of randomization | |
| 64 | NCT00311402 | completed | 0 | phase 3 | ['cerebrovascular accident'] | ["['A52.05', 'I67.81', 'I67.89', 'I67.9', 'I67.841', 'I67.858', 'I67.848']"] | ['aggrenox capsule'] | ['CC(=O)OC1=CC=CC=C1C(O)=O'] | Inclusion Criteria: Patients with a diagnosis of cerebral infarction (excluding cardiogenic cerebral embolism) who meet the diagnostic criteria based on the National Institute of Neurological Disorders and Stroke (NINDS) ad hoc committee's classification of cerebrovascular disease III. 1. Patients who have had an onset of cerebral infarction, the time of which is known, between 1 week and 6 months before the time of enrolment (including first and recurrent cerebral infarctions) 2. Patients who are 50 years or older 3. Patients whose neurological signs and symptoms are considered to be stable by the investigator or sub-investigator 4. Patients with a finding corresponding to the responsible focus confirmed by head X-ray computerised tomography (CT) or magnetic resonance imaging (MRI) 5. Patients who have at least two of the following risk factors: - diabetes - hypertension (systolic blood pressure is 140 mmHg or higher or diastolic blood pressure is 90 mmHg or higher) or under treatment of hypertension - smoker (at the time of onset of cerebral infarction) - obesity (Body mass index (BMI) is more than 25 kg/m2) - previous vascular disease (stroke, acute myocardial infarction or peripheral arterial disease before the onset of cerebral infarction) - end-organ damage (retinopathy, left ventricular hypertrophy (LVH) or microalbuminuria) - hyperlipidaemia Exclusion Criteria: 1. Patients with a diagnosis of brain disorders with a bleeding risk such as brain haemorrhage, subarachnoid haemorrhage, cerebral arteriovenous (AV) malformation, cerebral AV aneurysms and brain tumours 2. Patients with complications of cardiac disorders (atrial fibrillation, mitral valve stenosis, severe cardiac valve disorders) that may provide an embolic source for cerebral embolism 3. Patients having had acute coronary syndromes (acute myocardial infarction, unstable angina) within 6 months after enrolment in this study 4. Patient with hypersensitivity to dipyridamole preparations 5. Patients with a history of drug allergy to acetylsalicylic acid (ASA) or aspirin asthma 6. Patients with a history of peptic ulcer 7. Patients having undergone arterial reconstruction after development of cerebral infarction 8. Patients with very severe impairment (4 or 5 on Modified Rankin Scale) 9. Patients with bleeding or bleeding tendencies (haemophilia, haemorrhage urinary tract, vitreous haemorrhage, etc.) 10. Patients with severe hypertension (systolic blood pressure is 180 mmHg or higher or diastolic blood pressure is 110 mmHg or higher) 11. Patients with complications such as serious cardiac, renal and hepatic disorders 12. Patients with a malignant tumour or having had a tumour treatment in the past 5 years 13. Women who are or may be pregnant or lactating women | |
| 65 | NCT01059565 | completed | 0 | phase 3 | ['cystic fibrosis', 'burkholderia infections'] | ["['E84.9', 'Z14.1', 'E84.0', 'E84.11', 'E84.8', 'E84.19', 'P09.4']", "['K94.02', 'K94.12', 'K94.22', 'K94.32', 'N99.511', 'A02.9', 'A31.0']"] | ['azli', 'placebo'] | ['C[C@H]1[C@H](NC(=O)C(=N/OC(C)(C)C(=O)O)\\C2=CSC([NH3+])=N2)C(=O)N1S([O-])(=O)=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: 1. Male or female ≥ 6 years of age 2. Subjects with CF as diagnosed by one of the following: - Documented sweat chloride ≥ 60 milliequivalent (mEq)/L by quantitative pilocarpine iontophoresis test - Documented sweat sodium ≥ 60 mmol/L - Two well-characterized genetic mutations in the CF transmembrane conductance regulator (CFTR) gene - Abnormal nasal potential difference (NPD) with accompanying symptoms characteristic of CF 3. Chronic infection with Burkholderia spp. defined by: - One sputum (or bronchoalveolar lavage) culture positive for Burkholderia spp. within 6 months prior to baseline assessment, - At least 50% of sputum (or bronchoalveolar lavage) cultures collected at least one month apart over the previous 12 months prior to baseline assessment positive for Burkholderia spp. (minimum of 2 positive cultures), and - At least one positive sputum (or bronchoalveolar lavage) culture (obtained at any point in time) confirmed to be Burkholderia spp. by the Cystic Fibrosis Foundation (CFF) Burkholderia cepacia Research Laboratory and Repository at the University of Michigan (or equivalent Canadian reference laboratory). 4. Concomitant aerosolized antibiotic treatment: subjects receiving intermittent (alternating month on/month off) aerosolized antibiotic treatment were eligible, but must have been at least 1 week into their off-treatment cycle at the time of baseline assessment. Subjects receiving continuous aerosolized antibiotic treatment were eligible without restriction on their aerosolized antibiotic treatment. 5. Chest radiograph, computed tomography (CT), or magnetic resonance imaging (MRI) (most recent, obtained within 90 days of screening) without significant acute findings (eg, infiltrates [lobar or diffuse interstitial], pleural effusion, pneumothorax), and no significant intercurrent illness; chronic, stable findings (eg, chronic scarring or atelectasis) were allowed. 6. Subjects (and parent/guardian as required) must have been able to provide written informed consent/assent prior to any study-related procedures, 7. Ability to perform reproducible pulmonary function tests 8. Sexually active females of childbearing potential must have agreed to use a highly effective method of contraception during heterosexual intercourse throughout the study period and for 30 days following discontinuation of study drug. A highly effective method of birth control was defined as a method that would result in a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), or a vasectomized partner. Exclusion Criteria: 1. Administration of any investigational drug or use of any investigational device within 28 days of randomization/baseline and within six half-lives of the investigational drug (whichever is longer) 2. Administration of AZLI treatment within the 28 days prior to randomization/baseline 3. Known local or systemic hypersensitivity to monobactam antibiotics 4. History of lung transplantation 5. Abnormal renal or hepatic function results at most recent test within the previous 90 days, defined as: - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times the upper limit of the normal range (ULN) - Serum creatinine > 2 times ULN 6. Known portal hypertension or complications of CF hepatopathy 7. Positive urine pregnancy test (confirmed by serum pregnancy test) at screening; all women of childbearing potential were tested 8. Any female of childbearing potential who was lactating or not practicing a highly effective method of birth control as defined in the protocol 9. Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would have interfered with subject treatment, assessment or compliance with the protocol | |
| 66 | NCT00308503 | completed | 0 | phase 3 | ['sleep initiation and maintenance disorders', 'insomnia'] | ["['Y93.E9', 'Y93.H9']", "['F51.01', 'F51.02', 'F51.03', 'F51.04', 'G47.00', 'G47.09', 'A81.83']"] | ['eplivanserin (sr46349)', 'placebo'] | ['CN(C)CCO\\N=C(\\C=C\\C1=CC=C(O)C=C1)/C1=CC=CC=C1F', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for at least one month preceding the study visit. - Disturbance of sleep maintenance: - Based on patient' s information: - Patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks, - Patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month, - Patient must report impact on daytime functioning associated with sleep maintenance insomnia Inclusion will be based on the nocturnal polysomnography (NPSG) recordings performed at the sleep laboratory during the two screening nights. Exclusion Criteria: - Females who are lactating or who are pregnant, or of childbearing potential not using an acceptable form of contraception - Patients presenting with acute or chronic pain resulting in insomnia - Patients with current psychiatric disturbances - Body mass index > 32 - Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder, or any condition that may interfere with the absorption, metabolism, distribution or excretion of the study drug, or may affect patient safety - Clinically significant and abnormal electrocardiogram (ECG) (including QTc B > 500ms), - A positive test for hepatitis B (hepatitis B surface [HBs] antigens) or C (hepatitis C virus [HCV] antibodies) - Positive qualitative urine drug screen at screening - Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day - Use of any over-the-counter or prescription sleep medication, or of any substance with psychotropic effects or properties known to affect sleep/wake, within one week or five half-lives (whichever is longer), prior to screening - Night shift workers, and individuals who nap 3 or more times per week over the preceding month - Based on medical history and/or NPSG: - primary hypersomnia - narcolepsy - breathing-related sleep disorder (apnea-hypopnea index > 10/hour of sleep) - circadian rhythm sleep disorder - parasomnia (e.g. somnambulism) | |
| 67 | NCT00446199 | completed | 1 | phase 3 | ['vasomotor symptoms', 'hot flashes'] | ["['J30.0']"] | ['0.5mg drsp / 0.5mg e2 (bay86-4891)', '0.25mg drsp / 0.5mg e2 (bay86-4891)', 'estradiol (e2 0.3mg)', 'placebo'] | ['[H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=C(CC[C@@]21[H])C=C(O)C=C3', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Postmenopausal women >40 years of age experiencing a minimum of 7 to 8 moderate to severe hot flushes per day or 50 to 60 moderate to severe hot flushes per week Exclusion Criteria: - The usual exclusion criteria for hormone therapy apply - Intake of medications other than hormones affecting hot flushes | |
| 68 | NCT00269815 | completed | 1 | phase 3 | ['attention deficit hyperactivity disorder'] | ["['F90.2', 'F90.8', 'F90.9', 'F90.0', 'F90.1']"] | ['methylphenidate hcl'] | ['COC(=O)C(C1CCCCN1)C1=CC=CC=C1'] | Inclusion Criteria: - Patients who have successfully completed one of the following earlier ALZA studies: CR005992, C-97-033 (and then successfully completed C-98-011), CR005989, or CR005995, without significant drug-related adverse events - whose primary care physician agrees that it is appropriate to participate in this study - who agree to take only the OROS® (methylphenidate HCl) supplied and no other methylphenidate dosage form or other medications for the treatment of ADHD during the study - who are able to comply with the study visit schedule and whose parent(s) and teachers are willing and able to complete the protocol-specified assessments - who have normal urinalysis, hematological and blood chemistry values or, if values are outside the normal range, they are determined not clinically significant by the investigator Exclusion Criteria: - Patients having clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract - having any coexisting medical condition or are taking any medication that is likely to interfere with safe administration of methylphenidate - having a known hypersensitivity to methylphenidate - having a history of high blood pressure or who have a blood pressure (systolic or diastolic) equal to or greater than the 95th percentile for age, gender and height - if female, have begun menstruation | |
| 69 | NCT00289874 | completed | 0 | phase 3 | ['asthma'] | ["['J45.998', 'J82.83', 'J45.909', 'J45.991', 'J45.20', 'J45.30', 'J45.40']"] | ['montelukast sodium', 'comparator: placebo'] | ['[H][C@@]12C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C', 'CN(C)C(=N)NC(N)=N'] | Inclusion Criteria: - Male and female patients, ages 6 to 14 years, with persistent asthma that is also active during allergy season - Patients must demonstrate positive skin prick tests to seasonally relevant geographic aeroallergens Exclusion Criteria: - Patient cannot have any other acute or chronic pulmonary disorder | |
| 70 | NCT00249873 | completed | 1 | phase 3 | ['atrial fibrillation', 'vascular risk'] | ["['I48.0', 'I48.21', 'I48.91', 'I48.11', 'I48.19', 'I48.20']", "['G21.4', 'G95.19', 'I67.3', 'H34.9', 'I73.9', 'Q79.63', 'Z98.62']"] | ['clopidogrel (sr25990c)', 'placebo'] | ['[H][C@@](N1CCC2=C(C1)C=CS2)(C(=O)OC)C1=CC=CC=C1Cl', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: To be eligible for ACTIVE A patients must have in same time the three following conditions : - Evidence of atrial fibrillation either on one current Electrocardiogram (ECG) or two ECGs recorded at two weeks a part during 6 months prior to study enrollment. - Evidence of high risk of vascular events : at least one of the following risk criteria must be present : - are 75 years greater; - on treatment for systemic hypertension; - prior stroke, Transient Ischemic Attack (TIA) or non-Central Nervous System (non-CNS) systemic embolus; - left ventricular dysfunction with left ventricular ejection fraction (EF) estimated by echocardiogram or angiogram (radionuclide or contrast) to be < 45%; - peripheral vascular disease (previous peripheral artery revascularization, limb and foot amputation, or the combination of current intermittent claudication and ankle arm systolic blood pressure ratio < 0.9); - age 55 to 74 years and either; f1) diabetes mellitus requiring drug therapy, or f2) documented previous myocardial infarction or documented coronary artery disease. - To have either a contraindication to use an oral anticoagulant treatment or they are unwilling to take an oral anticoagulant treatment. Exclusion Criteria: Patients will be excluded from ACTIVE if any of the following are present : - requirement for clopidogrel (such as recent coronary stent procedure) - requirement for oral anticoagulant (such as prosthetic mechanical heart valve); - prior intolerance to ASA or clopidogrel; - documented peptic ulcer disease within the previous 6 months; - prior intracerebral hemorrhage; - significant thrombocytopenia; (platelet count < 50 x 10(9)/L) - psychosocial reason making study participation impractical; - geographic reason making study participation impractical; - ongoing alcohol abuse; - mitral stenosis, - pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study; (severe comorbid condition such that the patient is not expected to survive 6 months; - patient currently receiving an investigational pharmacologic agent; | |
| 71 | NCT00541450 | completed | 1 | phase 3 | ['type 2 diabetes mellitus'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['comparator: sitagliptin phosphate (sitagliptin)', 'sitagliptin phosphate (+) metformin hydrochloride', 'comparator: pioglitazone', 'matching placebo to pioglitazone', 'matching placebo to sitagliptin', 'matching placebo to sita/met fdc'] | ['N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F', 'CN(C)C(=N)NC(N)=N', 'CCC1=CN=C(CCOC2=CC=C(CC3SC(=O)NC3=O)C=C2)C=C1', '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', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Patients between the ages of 18 and 78 with type 2 diabetes mellitus - Patient has not been on any antihyperglycemic agent (Insulin or oral) in the last 3 months Exclusion Criteria: - Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis - Patient has previously been treated with sitagliptin or has previously been in a study using a DPP-4 inhibitor | |
| 72 | NCT00568685 | completed | 1 | phase 3 | ['attention deficit hyperactivity disorder'] | ["['F90.2', 'F90.8', 'F90.9', 'F90.0', 'F90.1']"] | ['atomoxetine hydrochloride', 'atomoxetine hydrochloride', 'atomoxetine hydrochloride'] | ['CNCC[C@@H](OC1=CC=CC=C1C)C1=CC=CC=C1', 'CNCC[C@@H](OC1=CC=CC=C1C)C1=CC=CC=C1', 'CNCC[C@@H](OC1=CC=CC=C1C)C1=CC=CC=C1'] | Inclusion Criteria: - Patients will be outpatients who are aged 6 to 18 years old at the initial screening visit. - Patients must have ADHD, based on the accepted criteria for that disease - Patients must not have taken any medication used to treat ADHD for at least two weeks prior to beginning study treatment; and at least one week prior to the study screening visit during which initial ADHD assessments were made - Patients must be able to swallow capsules - Patients and parents (or legal guardians) must be judged by the study investigator to be reliable to keep appointments for clinic visits and all tests, including blood tests and any other required examinations Exclusion Criteria: - Patients must not have received any treatment within the last 30 days with a drug that has not been approved by their country's appropriate government agency - Patients will not be included in the study if they have previously experienced any unwanted effects or serious medical events during atomoxetine treatment - Patients will not be included in the study if they are judged by the study investigator to be at serious suicidal risk - Patients will not be included in the study if they have cardiovascular disease or other conditions that could be worsened by an increased heart rate or increased blood pressure | |
| 73 | NCT00658320 | completed | 1 | phase 3 | ['kidney transplantation'] | ["['N26.2', 'Q63.0', 'Q63.2', 'Z52.4', 'I75.81', 'N19', 'N20.0']"] | ['everolimus', 'mycophenolate mofetil (mmf)', 'basiliximab', 'cyclosporine a', 'corticosteroid'] | ['[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](OCCO)[C@@H](C1)OC', 'COC(=O)\\C=C\\C(O)=O', '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', '[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C'] | Core Study Inclusion Criteria: - Male or female de novo renal transplant recipients between 18 and 65 years of age - Patients who are receiving a primary cadaveric donor or non-human leukocyte antigen (non-HLA) identical living donor kidney transplant - Patients who have given written informed consent to participate in the study - Females capable of becoming pregnant must have a negative pregnancy test prior to randomization. Core Study Exclusion Criteria: - Patients with no evidence of graft function within 24 hours of transplantation are excluded - Recipients of dual kidney transplants - Patients who are recipients of multiple solid organ or tissue transplants, or have previously received an organ or tissue transplant. - Recipients of kidneys from HLA-identical living related donors - Patients who are recipients of ABO incompatible transplants or T cell cross match positive transplant. Although Panel Reactive Antibodies (PRA) test is not mandatory, patients whose most recent anti-HLA Class I PRA >20% By a CDC-(Complement dependent cytotoxicity) based assay or >50% by a Flow Cytometry or ELISA (Enzyme linked immunosorbent assay) -based assay - Patients who have tested positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or Hepatitis B surface antigen. Laboratory results obtained within 6 months prior to randomization are acceptable, otherwise these tests should be performed within two weeks prior to randomization. - Recipients of organs from donors who test positive for Hepatitis B surface antigen, HCV or HIV are excluded - Donor organ with a cold ischemia time >24 hours - Donor age greater than 65 years - Patients with platelet count <100,000/mm at baseline before transplantation - Patients with an absolute neutrophil count of < 1,500/mm³ or white blood cell count of < 4,500/mm³ at baseline before transplantation - Patients who have severe hypercholesterolemia (>350 mg/dL; >9 mmol/L) or hypertriglyceridemia (>500 mg/dL; >8.5 mmol/L). Patients with controlled hyperlipidemia are acceptable - Patients who have an abnormal liver profile such as alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase (ALP) or total bilirubin >3 times the upper limit of normal (ULN) - Patients with a known hypersensitivity to either of the study drugs or their class, or to any of the excipients - Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 - Patients who are unable to take oral medication at time of randomization - Patients who received an investigational drug or who have been treated with a non-protocol immunosuppressive drug or treatment within 30 days or 5 half-lives prior to randomization - Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized excised non-melanomatous skin lesions - Patients with clinically significant systemic infection at time of transplant or within two weeks prior to transplant - Patients with a history of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus - Patients who have cardiac failure at time of screening (resting dyspnea, with Grade ≥ 3 according to Old New York Heart Association Classification (Appendix 7) or any severe cardiac disease as determined by the investigator - Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication - Patients with abnormal physical or laboratory findings of clinical significance within 2 weeks prior to randomization which would interfere with the objectives of the study - Patients with any history of coagulopathy or medical condition requiring long-term anticoagulation which would preclude renal biopsy after transplantation. (Low dose aspirin treatment or interruption of chronic anticoagulant is allowed) - Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception. Extension Study Inclusion Criteria: - Patients who completed Month 12 visit in core study (including patients who had discontinued study medication) - Patients who had given written informed consent to participate in this extension study Extension Study Exclusion Criteria: - Women of childbearing potential who were planning to become pregnant, who were unwilling to use two or more effective means of contraception, including abstinence judged by the investigator, surgical sterilization (e.g. bilateral tubal ligation, hysterectomy), hormonal contraception (implantable, patch, oral), and barrier methods (male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal were not acceptable methods of contraception. Other protocol-defined inclusion/exclusion criteria may apply | |
| 74 | NCT00221845 | completed | 1 | phase 3 | ['children', 'chronic renal failure', 'hypertension', 'acquired kidney disease', 'congenital kidney disease'] | ["['Y93.6A', 'Y92.110', 'Y92.111', 'Y92.112', 'Y92.113', 'Y92.114', 'Y92.115']", "['I13.11', 'I13.2']", "['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['ace inhibition', 'intensified blood pressure control', 'add-on angiotensin receptor blockade'] | ['[H][C@@]12CCC[C@]1([H])N([C@@H](C2)C(O)=O)C(=O)[C@H](C)N[C@@H](CCC1=CC=CC=C1)C(=O)OCC', 'CC1=CC(O)=CC(C)=C1Cl', '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: - Age 3-18 years - Moderate state of renal failure (creatinine clearance 15 - 75 ml / min / 1.73 m²) - Mean arterial blood pressure (ABPM) > 50.percentile and/or antihypertensive treatment - Written informed consent Exclusion Criteria: - Age <3 years or >18 years at start of study - Unstable clinical condition (vomiting, anorexia, etc) or superimposed important disease - Unilateral or bilateral renal artery stenosis - Urological surgery possibly affecting renal function expected during study period - Insufficient compliance with prescribed antihypertensive medication during the run-in period - Secondary renal diseases such as lupus, amyloidosis and primary hyperoxaluria, and patients treated with immunosuppressive agents (including corticosteroids) - Severe primary cardiac disease, hepatic insufficiency and malabsorption syndrome - Erythropoietin or growth hormone therapy with a duration of less than 3 months prior to run-in period - Pregnancy | |
| 75 | NCT00089856 | terminated | based on futility analysis showing <30% chance of meeting primary endpoint. | 0 | phase 3 | ['prostate cancer'] | ["['C61', 'D29.1', 'D40.0', 'Z15.03', 'Z80.42', 'Z85.46', 'Z12.5']"] | ['chemotherapy (taxotere 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 - Any Gleason score - ECOG performance status 0-2 Exclusion Criteria: - Prior treatment with chemotherapy - Prior Immunotherapy - Prior treatment with gene therapy - Significant cancer related pain |
| 76 | NCT00206089 | terminated | melagatran/ximelagatran was withdrawn from the market and clinical development in february 2006 in the interest of patient safety. | 0 | phase 3 | ['thromboembolism'] | ["['O88.22', 'O88.23', 'O88.211', 'O88.212', 'O88.213', 'O88.219']"] | ['exanta'] | ['CCOC(=O)CN[C@@H](C(=O)N1CC[C@H]1C(=O)NCC1=CC=C(C=C1)C(\\N)=N\\O)C1CCCCC1'] | Inclusion Criteria: - Signed informed consent, - Female or male aged 18 years and over - Patient scheduled for primary elective hip replacement or patient requiring surgery for hip fracture. Exclusion Criteria: - History of heparin-induced thrombocytopenia - Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency. - Myocardial infarction, Ischemic stroke or Transient Ischemic Attack (TIA), systemic embolism or venous thrombo-embolism within 30 days of enrollment. |
| 77 | NCT00163137 | completed | 1 | phase 3 | ['osteoporosis'] | ["['M81.6', 'Z82.62', 'Z13.820', 'M81.8', 'Z87.310', 'M81.0', 'M80.80XS']"] | ['lasofoxifene', 'raloxifene', 'placebo'] | ['[H][C@@]1(CCC2=CC(O)=CC=C2[C@@]1([H])C1=CC=C(OCCN2CCCC2)C=C1)C1=CC=CC=C1', 'CN\\C(NCCSCC1=CC=C(CN(C)C)O1)=C/[N+]([O-])=O', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Postmenopausal women with low bone density (osteopenia) and screening labs, pelvic ultrasound, mammogram without significant findings Exclusion Criteria: - Presence of metabolic bone disease, fractures, blood clots, or recent cancer. - Any use of selective estrogen receptor modulators, investigational drugs, or recent use of osteoporosis treatments, certain hormones, or medication for blood clots or seizures. | |
| 78 | NCT00250965 | terminated | terminated by dsmb; futility analysis showing mg treatment not efficacious | 0 | phase 3 | ['coronary artery disease', 'valvular heart disease'] | ["['I25.10', 'I25.110', 'I25.119', 'I25.111', 'I25.118']"] | ['intravenous magnesium'] | ['[Mg++]'] | Inclusion Criteria: - patient undergoing coronary artery bypass surgery with or without valve procedure - scheduled for on-pump or cardiopulmonary bypass protocol Exclusion Criteria: - existing atrial fibrillation/flutter in the past year or on antiarrhythmic medications - ventricular fibrillation - sustained ventricular tachycardia - 2nd or 3rd degree heart block - paroxysmal supraventricular tachycardia - major aortic repair planned during open-heart procedure - permanent atrial/ventricular pacemaker implanted - dialysis dependent or creatinine clearance < 35 umoles/min or oliguric/anuric renal failure - patient intolerant of beta blockers - patient has reactive airways disease dependent on regular beta-adrenergic agents - patient is scheduled to undergo off-pump surgical protocol |
| 79 | NCT00633919 | completed | 0 | phase 2/phase 3 | ['allergy'] | ["['T78.40XS', 'T78.49XS', 'Z91.010', 'Z91.012', 'Z91.013', 'Z91.030', 'Z91.040']"] | ['salbutamol inhaler', 'budesonide/formoterol inhaler', 'prednisone tablet', 'desloratadine tablet', 'budesonide nasal spray'] | ['CC(C)(C)NCC(O)C1=CC(CO)=C(O)C=C1', 'COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1', '[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C', 'ClC1=CC2=C(C=C1)C(=C1CCNCC1)C1=C(CC2)C=CC=N1', '[H][C@@]12C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C'] | Inclusion Criteria: - A clinical history of house dust mite induced persistent mild to moderate. asthma, with or without concurrent rhinoconjunctivitis, of at least 1 year of evolution. - Demonstration of a positive specific serum IgE test to Dermatophagoides during the year prior to the screening visit (CAP Class 2 or higher or equivalent). - Positive Skin Prick Test response (wheal diameter ≥ 3 mm) to Dermatophagoides mix. - If pre-menopausal female of childbearing potential, the subject must test negative on standard urine pregnancy test. - Willingness to comply with this protocol. Exclusion Criteria: - FEV1 < 70% of predicted value with appropriate medication. - Asthma controlled at randomization without need of inhaled corticosteroids or with a dose higher than 1000 µg/day of beclometasone or equivalent. - A clinical history of symptomatic perennial allergic asthma caused by allergens to which the subjects is regularly exposed (Alternaria, cat), other than house dust mites. - Chronic sinusitis. - Aspirin or sulfite intolerance. - Chronic obstructive pulmonary disease. - Current severe atopic dermatitis. - Severe asthma. - Use of an investigational drug within 30 days prior to screening. - Previous immunotherapy with house dust mite allergens for at least 2 years within the previous 10 years. - At randomisation, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process (se-rous otitis media is not an exclusion criterion). - Physical examination with clinically relevant findings. - Any of the following underlying conditions known or suspected to be present: Cystic fibrosis, malignancy, insulin-dependent diabetes, malabsorption or malnutrition, renal or hepatic insufficiency, chronic infection, drug dependency or alco-holism, ischaemic heart disease or angina requiring current daily medication or with any evidence of disease making implementation of the protocol or interpretation of the protocol results difficult or jeopardising the safety of the subject (e.g. clinically significant cardiovascular, serious immunopathologic, immunodeficiency whether acquired or not, hepatic, neurologic, psychiatric, endocrine, or other ma-jor systemic disease). - Immunosuppressive treatment. - A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the trial, and/or evidence of an uncooperative attitude. - Unlikely to be able to complete the trial. - Unwillingness to comply with trial protocol regimen for asthma and/or rhinoconjunctivitis medication. | |
| 80 | NCT01185340 | completed | 0 | phase 3 | ['major depressive disorder'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['ly2216684', 'placebo', 'ssri'] | ['[H][C@]1(CNCCO1)[C@@](O)(CC1=C(OC)C=CC(F)=C1)C1CCOCC1', '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: - Women of child-bearing potential may participate but must test negative for pregnancy at the time of study entry; both women/men agree to use a reliable method of birth control - Are being treated with one of the following selective serotonin reuptake inhibitors (SSRIs): escitalopram, citalopram, sertraline, fluoxetine, paroxetine, or fluvoxamine; for at least 6 weeks prior to investigational product dispensing with at least the last 4 weeks at a stable, optimized dose - Drug and dosage should be within the labeling guidelines for the specific country - Meet criteria for major depressive disorder (MDD), as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision® (DSM-IV-TR) criteria - Meet criteria for partial response, as defined by investigator's opinion that the participant has experienced a minimal clinically meaningful improvement with SSRI - Have a GRID 17-Item Hamilton Depression Rating Scale (GRID-HAMD17) total score greater than or equal to 16 at screening - Have less than or equal to 75% improvement on the current SSRI at screening determined by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) Exclusion Criteria: - Have had or currently have any additional ongoing DSM-IV-TR Axis 1 condition other than major depression within 1 year of screening - Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder [OCD], post-traumatic stress disorder [PTSD], generalized anxiety disorder [GAD], and social phobia, but excluding specific phobias) - Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder - Have a history of substance abuse and/or dependence within the past year (drug categories defined by DSM-IV-TR), not including caffeine and nicotine - Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol - Unstable medical conditions that contraindicate the use of LY2216684 - Have any diagnosed medical condition that could be exacerbated by noradrenergic agents, including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angled glaucoma, history of urinary hesitancy or retention - Use of excluded concomitant or psychotropic medication other than SSRI - Have initiated or discontinued hormone therapy within the 3 months prior to enrollment - History of treatment-resistant depression as shown by lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks or, in the judgment of the investigator, the participant has treatment-resistant depression - Have a lifetime history of vagal nerve stimulation (VNS), transcranial magnetic stimulation (TMS), or psychosurgery - Have received electroconvulsive therapy (ECT) in the past year | |
| 81 | NCT00003912 | completed | 0 | phase 3 | ['liver cancer'] | ["['D13.4', 'Z85.05', 'C22.8', 'C78.7', 'C22.9', 'D37.6']"] | ['carboplatin', 'cisplatin', 'doxorubicin hydrochloride'] | ['N[C@@H](CCCNC(N)=N)C(O)=O', '[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', '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'] | DISEASE CHARACTERISTICS: - Histologically proven hepatoblastoma or hepatocellular carcinoma - Diagnostic surgical biopsy strongly recommended for all patients and mandatory for the following: - Children under 6 months of age - Children over 3 years of age - Patients with a normal serum alfa-fetoprotein (alfa-FP) - Compatible imaging and raised serum alfa-FP level mandatory if no biopsy performed - Standard risk disease: - Tumors involving no more than 3 hepatic sections - No extrahepatic abdominal disease - No metastases - High risk disease: - Tumors involving all 4 hepatic sections AND/OR - Evidence of extrahepatic metastases or abdominal disease - Presence or absence of metastatic disease must be documented by chest x-ray and/or lung CT scan PATIENT CHARACTERISTICS: Age: - 16 and under at diagnosis Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics - Prior surgery allowed | |
| 82 | NCT00360308 | terminated | study stopped due to lack of efficacy. | 0 | phase 3 | ["parkinson's disease"] | ["['G20']"] | ['placebo', 'e2007', 'e2007'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O', 'O=C1N(C=C(C=C1C1=CC=CC=C1C#N)C1=NC=CC=C1)C1=CC=CC=C1', 'O=C1N(C=C(C=C1C1=CC=CC=C1C#N)C1=NC=CC=C1)C1=CC=CC=C1'] | Inclusion Criteria: 1. Male or female patients with idiopathic PD fulfilling the (United Kingdom [UK]) Parkinson's disease Society Brain Bank diagnostic criteria, with a good response to levodopa. 2. Patients must have been diagnosed with idiopathic PD at ≥ 30 years of age. In addition the onset of symptoms associated with Parkinson's disease must have occurred ≥ 30 years of age. 3. Patients must have predictable motor fluctuations of the wearing OFF type with the presence of at least 2 hrs of OFF time during the waking day (excluding the morning OFF time) as evidenced by diary cards completed at screening and confirmed by diary data collected in the 3 day diaries completed before randomisation. 4. Before patients are randomised, they must be able to show that they are able to accurately complete the diary cards. During the diary-training period at Screening Visit 1, there must be diary evidence of at least one transition of OFF to ON or from ON to OFF. 5. Patients must rate between II IV on the Hoehn &Yahr (8) scale when in an OFF state. 6. Patients must be taking optimised levodopa (plus dopamine decarboxylase inhibitors [DDI]) therapy (according to the Investigator's opinion) at least 3 times during the waking day (not including bedtime/night time dose) up to a maximum of 8 doses daily (including bedtime/night time dose). 7. Patients who are treated with DA or MAOB inhibitors or other anti-PD drugs must be on optimised and stable doses for at least 4 weeks prior to the Screening visit and must remain stable throughout the study. Only levodopa dosage can be adjusted downwards in the first 6 weeks of the double blind treatment phase. 8. In the Investigator's opinion, patients must be able to distinguish their own motor states and the absence or presence of troublesome or non-troublesome dyskinesias. 9. In the Investigator's opinion, patients are able to complete the study including the completion of the home diary cards and are capable of giving full written informed consent. Exclusion Criteria: 1. Pregnant or lactating women. 2. Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g., abstinence, intrauterine device or barrier method plus hormonal method). These patients must have a negative serum B-human chorionic gonadotrophin (B-HCG) test at the initial screening visit (Visit 1) and a negative urine pregnancy test at the baseline visit (Visit 3). These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrhoeic for at least 1 year to be considered of non child bearing potential as determined by the Investigator. 3. Patients with a past or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual of Mental Disorders (4th edition; DSM IV) criteria. 4. Patients with a past (within 1 year) or present history of psychotic symptoms requiring anti psychotic treatment. Patients may be taking anti-depressant medication; however, the dose must be stable for 4 weeks prior to the Screening visit. Use of anti psychotic medication including clozapine and quetiapine is prohibited. 5. Patients with a past (within 1 year) or present history of major depression, suicidal ideation or suicide attempts. 6. Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, haematological, endocrine or metabolic systems that might complicate assessment of the tolerability of the study medication. 7. Patients who have a past or present history of liver impairment, neuroleptic malignant syndrome, non traumatic rhabdomyolysis or pheochromocytoma. 8. Patients with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper normal limit). 9. Patients with current or prior treatment (within 4 weeks prior to the Screening visit) with medication known to induce the enzyme CYP3A4. 10. Current or prior treatment (within 4 weeks prior to the Screening visit) with pergolide (only applies to patients entering after April 5, 2007), cabergoline (effective as of the date of the IRB/IEC approval of this amendment), tolcapone, methyldopa, budipine, reserpine, quetiapine or intermittent use of either liquid forms of levodopa or subcutaneous apomorphine. 11. Current treatment with non selective MAOA/B or combination of selective MAOA and selective MAOB inhibitors. 12. Patients with a known hypersensitivity to the active substance or to any of the excipients of entacapone. 13. Patients with previous stereotactic surgery (e.g., pallidotomy) for PD or with planned stereotactic surgery during the study period. 14. Patients receiving or with planned (next 6 months) deep brain stimulation. 15. Patients who have received entacapone previously or are currently using entacapone. 16. Patients who have received an investigational product within 4 weeks prior to the Screening visit or patients who have participated in a previous study with E2007. 17. Patients with clinically significant cognitive impairment (Mini Mental State Examination [MMSE] <24 or fulfilling DSM IV criteria for dementia due to PD). 18. Patients with conditions affecting the peripheral or central sensory system unless related to PD (such as mild sensory or pain syndromes limited to OFF periods) that could interfere with the evaluation of any such symptoms caused by the study drug. 19. Patients with any condition that would make the patient, in the opinion of the Investigator, unsuitable for the study. |
| 83 | NCT01436149 | completed | 0 | phase 3 | ['major depressive disorder'] | ["['F33.0', 'F33.1', 'F33.9', 'F32.0', 'F32.1', 'F32.9', 'F33.40']"] | ['spd489 (lisdexamfetamine dimesylate )', 'placebo'] | ['C[C@@H](CC1=CC=CC=C1)NC(=O)[C@@H](N)CCCCN', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Subject is able to provide written, personally signed, and dated informed consent to participate in the study. - Subject is between 18 and 65 years of age. - Subject has a primary diagnosis of non-psychotic MDD (single or recurrent). - Subject has a MADRS total score 24. - Subject who is female, must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test and a negative urine pregnancy test at the and agrees to comply with any applicable contraceptive requirements of the protocol. - Subject is able to swallow a capsule. Exclusion Criteria: - Subject whose current episode of MDD has not responded to an adequate treatment regimen with 2 or more approved single antidepressant agents. - Subject who has a lifetime history of treatment resistant depression. - Subject has a current co-morbid psychiatric disorder. Excluded are: any significant Axis II disorder (including borderline personality disorder), any bipolar disorder, any current or lifetime psychosis, post traumatic stress disorder, obsessive compulsive disorder, any pervasive development disorder, anorexia nervosa and bulimia nervosa. - Subject has been hospitalized (within the last 12 months) for their current MDD episode. - Subject has a current or lifetime history of attention-deficit/hyperactivity disorder (ADHD). - Subject has a first degree relative that has been diagnosed with bipolar I disorder. - Subject has a recent history (within the last 6 months) of suspected substance abuse or dependence disorder - Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt within the past 3 years, or is currently demonstrating active suicidal ideation. - Subject has a concurrent chronic or acute illness or unstable medical condition. - Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions. - Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. - Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months prior to the Screening Visit. - Subject has a known family history of sudden cardiac death or ventricular arrhythmia. - Subject has glaucoma. - Subject has a history of moderate to severe hypertension. - Current use of any other medications (including over-the-counter [OTC], herbal or homeopathic preparations) that have central nervous system effects. - Subject has had electroconvulsive therapy (ECT) for the current depressive episode 3 months prior. - The subject has a known or suspected intolerance, hypersensitivity, or contraindications to their assigned antidepressant treatments (escitalopram oxalate, sertraline HCl, venlafaxine HCl extended release, or duloxetine HCl). - Subject has a positive urine drug result. - Subject has a body mass index (BMI) of <18.5 or >40. - Subject is female and is pregnant or nursing. | |
| 84 | NCT00578695 | completed | 1 | phase 3 | ['hyponatremia'] | ["['P74.22', 'E87.1']"] | ['lixivaptan', 'placebo'] | ['CC1=CC=C(F)C=C1C(=O)NC1=CC=C(C(=O)N2CC3=CC=CN3CC3=C2C=CC=C3)C(Cl)=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 18 years of age or older with hyponatremia and hospitalized for congestive heart failure. | |
| 85 | NCT00549757 | terminated | lack of benefit and safety concern | 0 | phase 3 | ['type 2 diabetes mellitus', 'cardiovascular disease'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']", "['A52.00', 'A52.09', 'A50.54', 'Z01.810', 'Q87.418', 'Z13.6', 'R94.30']"] | ['aliskiren', 'placebo'] | ['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', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Type 2 diabetes and at least one of the following: - Macroalbuminuria and an eGFR ≥30 mL/min/1.73 m2 - Microalbuminuria and a reduced kidney function (eGFR eGFR ≥30 and <60 mL/min/1.73 m2) - A history of CV disease (previous MI, previous stroke, heart failure, coronary artery disease, history of percutaneous coronary intervention, angiography proven stenosis ≥50% in at least one coronary artery and a reduced kidney function (eGFR ≥30 and <60 mL/min/1.73 m2) - Concomitant treatment should follow national guidelines and must include either an Angiotensin-converting-enzyme-inhibitor (ACEi) or an Angiotensin-receptor-blocker (ARB) but not both. Exclusion Criteria: - Type 1 diabetes mellitus - Cardiovascular event or procedure ≤ 3 months prior to Visit 1 - Unstable serum creatinine - Hypertension: Mean sitting systolic blood pressure (msSBP) ≥ 135 and < 170 mmHg or Mean sitting diastolic blood pressure (msDBP) ≥ 85 and < 110 mmHg unless treated with at least 3 anti-hypertensive medications - Hypertension msSBP ≥ 170 or msDBP ≥ 110 mmHg - Baseline Serum Potassium > 5.0 mmol/L - Patients who are treated with two renin-angiotensin-aldosterone-system-blockers - Patients with NYHA class III or IV heart failure - Known renal artery stenosis - Previous randomization into the AVOID trial (CSPP100C2201) EXCLUSION SPECIFIC TO THE SAFETY FOLLOW-UP PERIOD: - Aliskiren or aliskiren containing fixed combination products must not be used Other protocol-defined inclusion/exclusion criteria applied |
| 86 | NCT00658736 | completed | 0 | phase 3 | ['chronic pancreatitis'] | ["['K86.1', 'K86.0']"] | ['triamcinolone', 'bupivicaine alone'] | ['[H]\\C(=C(\\[H])C1=CC=C(OC)C=C1)C(=O)OCC(CC)CCCC', 'CNC[C@H](O)C1=CC(O)=C(O)C=C1'] | Inclusion criteria include: - Age >18 yrs - Ability for informed consent - Chronic pancreatic-type abdominal pain (type B) (11). Exclusion criteria include: - Pregnancy - Malignancy - Recent acute pancreatitis (within 2 months) - Elevated INR (>1.5) or low platelet count (<75 cells/mm3) - Allergy to eggs or "caine" anesthetics or corticosteroids; AND - Becks depression score>20. | |
| 87 | NCT00627445 | completed | 1 | phase 3 | ['diabetes', 'diabetes mellitus, type 2'] | ["['E23.2', 'N25.1', 'P70.2', 'O24.92', 'Z83.3', 'Z86.32', 'E10.65']", "['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['biphasic insulin aspart 30', 'metformin', 'biphasic insulin aspart 50'] | ['[Na+].[Na+].[O-]P([O-])(F)=O', 'CSCC[C@H](N)C(O)=O', '[Na+].[Na+].[O-]P([O-])(F)=O'] | Inclusion Criteria: - Type 2 diabetes - Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months - HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive) - FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L - BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive) Exclusion Criteria: - Metformin contraindications according to local practice - Systemic use of TZDs (thiazolidinediones) for more than 1 month within 6 months prior to this trial | |
| 88 | NCT00643851 | completed | 1 | phase 3 | ['type 2 diabetes'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['dapagliflozin', 'metformin xr'] | ['CN(C)C(=N)NC(N)=N', 'CN(C)C(=N)NC(N)=N'] | Inclusion Criteria: - Males & females, 18-77 years old inclusive, with type 2 diabetes and with inadequate glycemic control - Drug naive or treated with anti-diabetic medication for < 24 weeks since original diagnosis - C-peptide ≥ 1.0 ng/mL - Body Mass Index ≤ 45.0 kg/m - Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women Exclusion Criteria: - AST and/or ALT >3.0 times the upper limit of normal (ULN) - Serum total bilirubin > 2.0 mg/dL - Creatine kinase > 3X the upper limit of normal (ULN) - Symptoms of severely uncontrolled diabetes - Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric or rheumatic diseases | |
| 89 | NCT00551616 | completed | 1 | phase 3 | ['contraception'] | ["['Z92.0', 'Z30.012', 'Z30.09']"] | ['cdb-2914', 'levonorgestrel'] | ['CN(C)C1=CC=C(C=C1)[C@H]1C[C@@]2(C)[C@@H](CC[C@]2(O)C(C)=O)[C@@H]2CCC3=CC(=O)CCC3=C12', '[H][C@@]12CC[C@@](O)(C#C)[C@@]1(CC)CC[C@]1([H])[C@@]3([H])CCC(=O)C=C3CC[C@@]21[H]'] | Inclusion Criteria: - women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern Ireland (UK) and 18 years or more in Ireland and US - present within 120 hours of unprotected intercourse - regular menstrual cycles - No current use of hormonal contraception - Willing to not use hormonal methods of contraception until study completion - At least one complete menstrual cycle (2 menses) post miscarriage, delivery or abortion - For women who present more than 72 hours after intercourse, decline the insertion of an IUD for emergency contraception - Able to provide informed consent - Willing to abstain from further acts of unprotected intercourse until study completion Exclusion Criteria: - One or more acts of unprotected intercourse more than 120 hours - current or recent use of hormonal methods of contraception - currently pregnant or breastfeeding - tubal ligation or current use of IUD - Use of hormonal emergency contraception since last menstrual period - Current use of IUD - Tubal ligation - Partner with a vasectomy - Unsure about the date of the last menstrual period - Severe asthma insufficiently controlled by oral glucocorticoid - Hypersensitivity to the active substance levonorgestrel or any of the excipients of the drug products used in the study | |
| 90 | NCT00655551 | completed | 1 | phase 3 | ['partial epilepsies', 'partial onset seizures'] | ["['G40.011', 'G40.019', 'G40.001', 'G40.009']"] | ['lacosamide', 'lacosamide', 'lacosamide'] | ['COC[C@@H](NC(C)=O)C(=O)NCC1=CC=CC=C1', 'COC[C@@H](NC(C)=O)C(=O)NCC1=CC=CC=C1', 'COC[C@@H](NC(C)=O)C(=O)NCC1=CC=CC=C1'] | Inclusion Criteria: - Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures - Stable dose regimen of 1 to 2 marketed antiepileptic drug(s) (AED(s)) for 28 days prior to screening and duration of trial - Acceptable candidate for venipuncture and intravenous (iv) infusion - At least 1 partial seizure with motor component per 90 days - Maximum allowed seizure frequency during 28 days prior to screening is 40 partial seizures of any type Exclusion Criteria: - Previous use of lacosamide - History of primary generalized seizures - History of status epilepticus within last 12 months - History of cluster seizures during 8 week period prior to screening - Non-epileptic events, including psychogenic seizures that could be confused with seizures - Use of neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening - Received any rescue benzodiazepines more than once during the 28 days prior to screening - Concomitant treatment of felbamate or previous felbamate therapy within last 6 months - Prior or concomitant vigabatrin use | |
| 91 | NCT01136954 | completed | 1 | phase 3 | ['partial seizures'] | ["['G40.111', 'G40.119', 'G40.211', 'G40.219', 'G40.101', 'G40.109', 'G40.201']"] | ['zonisamide'] | ['NS(=O)(=O)CC1=NOC2=CC=CC=C12'] | INCLUSION CRITERIA: 1. Subject has completed the double-blind study E2090-E044-312. 2. Parent/caregiver is willing to sign an informed consent where the subject is under the age of consent. 3. Subject is male or female aged 6 to 18 years who is willing to give informed (written or verbal) assent, if applicable. If mandated by local regulations, subjects of relevant age will be required to sign an appropriate informed consent. 4. Subject is in general good health as determined by medical history, physical exam and screening laboratory results. EXCLUSION CRITERIA: 1. Subject has a body weight < 20 kg. 2. Subject has developed a history of renal calculi or renal insufficiency (creatinine level > 135 µmol/l (1.5 mg/dl). 3. Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C. 4. Subject has a history of sensitivity to sulfonamide drugs or zonisamide and its excipients. 5. Female subject of 10 years of age or greater, or of child bearing potential (i.e. started menses) and is not taking or prepared to take a medically acceptable form of contraception (i.e. oral contraceptive pill, surgical sterilization, an implant or injected form of contraception, or intrauterine device), or who is not prepared to abstain from sexual activity for the duration of the study and for one month after the last administration of study medication. NOTE: Should a female subject become of child bearing potential during the study, they must be reconsented in order to given consent to undergo pregnancy testing and either confirm abstinence or receive a medically appropriate form of contraception. 6. Subject has a recent history of excessive alcohol use or drug abuse. 7. Subject has a history of suicide attempt. 8. Subject has a clinically significant organic disease. 9. Subject has a history of demonstrated non-compliance with treatment or subject or parent/legal guardian can be reasonably expected not to be compliant with study procedures or to complete the study. 10. Frequent need of rescue benzodiazepines (one or more times a month). 11. Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate, furosemide and drugs with anticholinergic activity. 12. Concomitant use of felbamate or use of felbamate within 2 months prior to Visit 1 of the E2090-E044-312 study. | |
| 92 | NCT00220831 | terminated | interim analysis showed significant differences between two treatment groups | 1 | phase 2/phase 3 | ['diabetes', 'myocardial infarction', 'cardiovascular disease'] | ["['E23.2', 'N25.1', 'P70.2', 'O24.92', 'Z83.3', 'Z86.32', 'E10.65']", "['I25.2', 'I21.9', 'I21.A1', 'I21.A9', 'I21.4', 'I22.2', 'I23.8']", "['A52.00', 'A52.09', 'A50.54', 'Z01.810', 'Q87.418', 'Z13.6', 'R94.30']"] | ['natural source vitamin e 400iu/day'] | ['CC(C)CCC[C@@H](C)CCC[C@@H](C)CCC[C@]1(C)CCC2=C(O1)C(C)=C(C)C(O)=C2C'] | Inclusion Criteria: - Diabetic patients aged 55 and above Exclusion Criteria: - Patient who takes antioxidant treatment will be asked to stop, or can't be included in the study - Patients who had a CVD incident (MI, Stroke, TIA), Unstable angina pectoris, Uncontrolled HTN, will have to wait a month after stabilization to be included in the study - Allergy to Vitamin E |
| 93 | NCT00633932 | completed | 1 | phase 3 | ['reflux esophagitis'] | ["['K21.9', 'K21.00', 'K21.01']"] | ['esomeprazole', 'esomeprazole', 'omeprazole'] | ['COC1=CC2=C(NC(=N2)[S@@](=O)CC2=NC=C(C)C(OC)=C2C)C=C1', 'COC1=CC2=C(NC(=N2)[S@@](=O)CC2=NC=C(C)C(OC)=C2C)C=C1', '[Na+].OC([O-])=O'] | Inclusion Criteria: - Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation Exclusion Criteria: - Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation. - Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation. | |
| 94 | NCT00295594 | completed | 1 | phase 3 | ['liver transplantation'] | ["['Z52.6', 'K71.8', 'K71.7', 'A06.4', 'C22.0', 'C22.3', 'K70.0']"] | ['tacrolimus'] | ['COC1=CC2=C(C(OC)=C1OC)C1=CC=C(OC)C(=O)C=C1C(CC2)NC(C)=O'] | Inclusion Criteria: - Patients 18 years of age or older who will undergo primary orthotopic liver or split liver allograft transplantation are eligible for the study. Patients receiving a liver transplant from cadaveric heart-beating donor with compatible AB0 blood type can be included. Exclusion Criteria: - Recipient of an auxiliary graft - Patient is requiring initial sequential or parallel therapy with other immunosuppressive antibody preparation(s). - Patient is requiring ongoing dosing with corticosteroids. - Patient is exhibiting symptoms of, or is having any previous history of neoplastic disease - Patient or donor is known to be HIV positive. - Patient is allergic or intolerant to study medication | |
| 95 | NCT00354991 | completed | 1 | phase 3 | ['hypertension'] | ["['I15.0', 'I97.3', 'K76.6', 'P29.2', 'G93.2', 'H40.053', 'I10']"] | ['losartan potassium (+) hydrochlorothiazide'] | ['NS(=O)(=O)C1=C(Cl)C=C2NCNS(=O)(=O)C2=C1'] | Inclusion Criteria: - Patient is male or female and = 18 years of age - Patients with essential hypertension previously treated with antihypertensive medications for at least 4 weeks but did not reach the blood pressure goal Exclusion Criteria: - History of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient/subject to participate - Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study - Previous history of severe essential hypertension - History of stroke or myocardial infarction (heart attack) - Evidence of renal or liver disease - Uncontrolled diabetes mellitus - Any known bleeding disorder - Known sensitivity or intolerance to the study medication (losartan or hydrochlorothiazide) - Other antihypertensive medications or medications that may affect blood pressure | |
| 96 | NCT00145925 | completed | 1 | phase 3 | ['diabetes mellitus, type 2'] | ["['E11.65', 'E11.9', 'E11.21', 'E11.36', 'E11.41', 'E11.42', 'E11.44']"] | ['perindopril-indapamide', 'gliclazide mr-based glucose lowering'] | ['CC1=CC=C(C=C1)S(=O)(=O)NC(=O)NN1CC2CCCC2C1'] | Inclusion Criteria: 1. A diagnosis of type 2 diabetes mellitus first made at age 30 years or older 2. Age 55 years or older at entry 3. Ability to provide informed consent 4. A substantially elevated risk of cardiovascular disease, indicated by: - A history of major macrovascular disease defined as any one of: stroke, myocardial infarction, hospital admission for transient ischaemic attack, hospital admission for unstable angina, coronary artery bypass graft, percutaneous transluminal coronary angioplasty (with or without stenting), peripheral revascularisation (angioplasty or surgery) or amputation secondary to vascular disease or - A history of major microvascular disease defined as any one of nephropathy (albumin:creatinine ratio >300ug/mg), retinal photocoagulation therapy, proliferative retinopathy (new blood vessels on the disc or elsewhere, vitreous haemorrhage, pre-retinal haemorrhage, or fibrous proliferations on the disc or elsewhere), macular oedema (retinal thickening within one disc diameter of the macular centre) or blindness in either eye (corrected visual acuity 6/60 or worse, persisting for three months or more) not known to be due to non-diabetic causes or - A first diagnosis of type 2 diabetes made 10 or more years prior to entry or - Another major risk factor for vascular disease defined as any one of: current daily cigarette smoking, total cholesterol greater than 6.0 mmol/l (with or without cholesterol lowering treatment), HDL cholesterol <1.0 mmol/l, microalbuminuria (albumin:creatinine ratio 30-300ug/mg) or - Age 65 years or over Exclusion Criteria: 1. A definite contraindication to treatment with an ACE inhibitor or a thiazide-like diuretic 2. A specific indication for treatment with an ACE inhibitor other than perindopril 2-4 mg daily (see also section 5.2.3) or a thiazide-like diuretic 3. A definite and specific indication for treatment with gliclazide or a haemoglobin A1c control target of 6.5% or less 4. A definite contra-indication to treatment with gliclazide or a haemoglobin A1c control target of 6.5% or less 5. A definite indication for long-term full-dose or bed-time insulin therapy 6. Participation in a trial within the month prior to the Registration Visit or current participation in another trial Other potential reasons for ineligibility include: - High probability of non-adherence to study treatment or follow-up - Current clinical instability (e.g. a major cerebral or coronary event or sight-threatening retinopathy or macular oedema within the previous few weeks) - Life threatening non-vascular disease other than diabetes and its complications - Moderate or severe dementia - Major disability that is likely to prevent regular attendance at study clinics Final decisions about eligibility were made at the discretion of the study investigator and the potential study participant, in the light of any requirements or guidance from local ethics committees and other regulatory bodies. | |
| 97 | NCT01328379 | completed | 0 | phase 3 | ['multiple sclerosis'] | ["['G35', 'C81.18']"] | ['dalfampridine-er 5mg', 'dalfampridine-er 10mg'] | ['NC1=CC=NC=C1', 'NC1=CC=NC=C1'] | Inclusion Criteria: - Patient has clinically definite Multiple Sclerosis as defined by the MacDonald Criteria. - Patient must be 18 to 70 years of age, inclusive (i.e. on or after their 18th birthday, up to the day before their 71st birthday at the Screening Visit). - Patient who has previously taken Ampyra® or dalfampridine (fampridine or 4 aminopyridine; 4-AP) in any formulation (including compounded), must have withdrawn from the drug for at least one month prior to the Screening Visit. - Patient must be mentally competent to understand and sign the Internal Review Board (IRB)-approved informed consent prior to the performance of any study-specific procedures. - Patient is able to perform all the required study procedures. - In the judgement of the Investigator, the patient has MS-related walking impairment but has sufficient ambulatory ability to be able to complete two trials of the Timed 25 Foot Walk (T25FW) at the screening Visit and every study visit thereafter, with the two trials completed within 5 minutes of one another and in accordance with the specific instructions provided by the National Multiple Sclerosis Society MS Functional Composite Manual. - Patient who is female and of childbearing potential (see Exclusion Criterion 1 for definition) must have a negative urine pregnancy test at the Screening Visit. Exclusion Criteria: - Patient is a female of childbearing potential (i.e., has not had a hysterectomy or bilateral oophorectomy, or is not at least two years postmenopausal), engaged in active heterosexual relations and is not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch or injectable contraceptive, double barrier method, or sexual activity restricted to vasectomized partner. - Patient is pregnant or breastfeeding. - Patient has any history of seizures. - Patient has moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 mL/minute. - Patient has active urinary tract infection (UTI) at Screening or within the 4 weeks before Screening. - Patient has had an onset (as assessed by the treating physician) of an MS exacerbation within 60 days prior to the Screening Visit. - Patient has started on a concomitant prescription medication regimen within the last three weeks, and/or their concomitant medication regimen is expected to change during the course of the study. - Patient has received cyclophosphamide (Cytoxan) or mitoxantrone (Novantrone) for MS treatment within six months prior to the Screening Visit. - Patient has started a treatment regimen of Betaseron, Avonex, Copaxone, Rebif, Tysabri, Extavia or Gilenya™ within 90 days prior to the Screening Visit or has had any change in the dosing regimen of these drugs within 30 days prior to the Screening Visit. - Patient has received corticosteroids (other than topical preparations) within 30 days prior to the Screening Visit and/or is expected to receive regularly scheduled corticosteroid treatment during the course of the study. - Patient has been administered botulinum toxin in the lower extremities within six months prior to the Screening Visit and/or is expected to receive botulinum toxin in the lower extremities during the course of the study. - Patient has a known allergy to pyridine-containing substances or any of the inactive ingredients of the dalfampridine tablet (colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide). - Patient has a history of drug or alcohol abuse within the past year. - Patient has clinically significant abnormal laboratory values. - Patient has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality. - Patient has any medical condition (including psychiatric disease)that would interfere with the interpretation of the study results or the conduct of the study. - Patient has participated in an investigational trial 30 days prior to Screening Visit or plans to enroll in another investigational trial at any time during this study. Non-drug (i.e. observational, registry) and non- medical device trials are allowed. | |
| 98 | NCT00427648 | terminated | funding ran out, poor accrual. | 0 | phase 3 | ['overactive bladder'] | ["['N32.81']"] | ['alkalinized xylocaine', 'placebo'] | ['CNC[C@H](O)C1=CC(O)=C(O)C=C1', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion criteria: - Female patient, 18 years of age and older - Overactive bladder defined as: - Urinary frequency defined as eight or more voids in a 24 hour period > 50% of days of the week - Symptoms of urgency - Symptoms of at least three months duration Exclusion criteria: - Positive urine culture in the past month, or more than 3 episodes of bladder infection in the last 2 months - Stress or overflow urinary incontinence (determined by clinician) if more than 14 episodes of urinary incontinence per week; also insensate incontinence - Pregnancy - Seizure disorder or clinically significant renal disease, allergy to lidocaine, uninvestigated hematuria, or history of urinary/reproductive tract malignancy - Post-void residual more than 200 cc |
| 99 | NCT01493960 | completed | 0 | phase 3 | ['colitis, ulcerative'] | ["['K51.80', 'K51.813', 'K51.814', 'K51.90', 'K51.913', 'K51.914', 'K51.811']"] | ['cobitolimod', 'placebo'] | ['CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: 1. Male or female ≥ 18 years of age. 2. Well established diagnosis of moderate to moderately severe chronic active UC with a CAI score ≥9, an endoscopic score ≥2, not responding adequately to currently available therapies and potential candidates for colectomy. Previously tried therapies should include: - At least one treatment course with mesalazine; at least 2.4 g/day for at least 4 weeks, or at least one treatment course with similar drugs in this class. - At least one full dose treatment course of corticosteroids (which can be the treatment of a recent relapse), with up to 0.75 mg/kg as a starting dose or highest dose according to local clinical practice. - At least one treatment course of azathioprine or mercaptopurine of at least 3 months duration and/or at least one adequate treatment course of an anti-TNF alpha. - Any unsuccessful combination treatment of the above. - May have tried treatment with cyclosporine and/or tacrolimus or any other immunosuppressant/immunomodulating agent. - Intolerance to any of the above medications is judged as inadequate response. 3. Patients shall at study enrolment be on an accumulated stable tolerable GCS dose equivalent to at least 140 mg of prednisolone/prednisone (by any route of administration) for the last two weeks. Patients may also be on concomitant therapies such as, but not restricted to, 5-ASA, azathioprine and sulphasalazine. 4. Ability to understand the treatment, willingness to comply with all study requirements, and ability to provide informed consent. Exclusion Criteria: 1. Patients with suspicion of Crohn's enterocolitis, ischaemic colitis, radiation colitis, diverticular disease associated colitis, as well as microscopic colitis should be excluded. Patients with disease limited to the rectum (ulcerative proctitis) should also be excluded. 2. History or presence of a clinically significant cardiovascular, hepatic, renal, haematological, endocrine, neurological, psychiatric disease, or immune compromised state as judged relevant by the investigator. 3. Patients with acute fulminant UC and/or signs of systemic toxicity to an extent that requires immediate surgical action. 4. History or presence of any colonic malignancy and/or dysplasia. 5. Concomitant treatment with cyclosporine, tacrolimus, anti-TNFs or similar immunosuppressants/immunomodulators is not allowed and should have been discontinued 4 weeks before enrolment. Patients who fail the wash-out criteria can undergo wash-out and be re-screened at a later time point. Ongoing treatment of anti-TNFs, tacrolimus or similar immunomodulators/immunosuppressant drugs should only be stopped in case of documented lack of efficacy or in case of intolerable side effects. 6. Treatment with antibiotics or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within two weeks before enrolment. 7. An active ongoing infection. 8. History of latent or active tuberculosis, evidence of prior or currently active tuberculosis by chest x-ray, patient with or having had frequent close contact with person with active tuberculosis, patients who previously have tested positive for a tuberculin skin test, or Mantoux (PPD) test, except in the case of previous vaccination or positive interferon gamma release test during screening or within 12 weeks prior to randomisation. 9. Known history of HIV infection based on documented history with positive serology or HIV positive serology. 10. Previously documented positive hepatitis B surface antigen determination, determination of total antibodies to the hepatitis B capsid antigen and/or hepatitis C antibody (HCVAb) with confirmation using the ribonucleic acid of hepatitis B virus. 11. Positive Clostridium difficile stool assay. 12. Currently receiving parenteral nutrition or blood transfusions. 13. Pregnancy or breast-feeding. 14. Women of childbearing potential not using reliable contraceptive methods (reliable methods are barrier protection, hormonal contraception, intra-uterine device or abstinence) throughout the duration of the study (52 weeks). 15. Concurrent participation in another clinical study with investigational therapy or previous use of investigational therapy within 30 days before enrolment. Patients who fail the wash-out criteria can undergo wash-out and be re-screened at a later time point. | |
| 100 | NCT00337571 | completed | 1 | phase 3 | ['behavioral symptoms', 'autistic disorder'] | ["['F84.0']"] | ['aripiprazole', 'placebo'] | ['ClC1=CC=CC(N2CCN(CCCCOC3=CC4=C(CCC(=O)N4)C=C3)CC2)=C1Cl', 'CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O'] | Inclusion Criteria: - Meets current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for AD and demonstrates serious behavioral problems; diagnosis confirmed by Autism, Diagnostic Interview-Revised (ADI-R). - CGI score > = 4 AND an ABC Irritability/Agitation subscale score > = 18 at screening and baseline (randomization) - Mental age of at least 18 months - Male or female 6 to 17 years of age inclusive, at the time of randomization Exclusion Criteria: - Patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each - Patients previously treated and not responding to aripiprazole treatment - The patient is currently diagnosed with another disorder on the autism spectrum, including PDD-NOS, Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or Childhood Disintegrative Disorder - Current diagnosis of bipolar disorder, psychosis, schizophrenia, or major depression - A seizure in the past year - History of severe head trauma or stroke - Non-pharmacologic therapy (e.g., psychotherapy, behavior modification) should be stable prior to screening and consistent throughout the study |