Kusajili – Centralise les essais cliniques mondiaux

A Study of SR58611A in the Prevention of Depression Relapse in Patients With Major Depressive Disorder The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of depressive symptoms in patients with major depressive disorder. Relapse will be assessed using the MADRS scale.Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with SR58611A are randomized to continue SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional treatment. The secondary objective is to evaluate the safety of SR58611A in patients with MDD.

• Pays Argentina, Bulgaria, Croatia, Czech Republic, Finland, France, Mexico, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa,
• Organes Aucun
• Spécialités Aucun

Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites. Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

• Pays Argentina, Australia, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Malaysia, Portugal, Romania, Serbia, Singapore, South Africa, Spain, Taiwan, Province of China, United Kingdom, United States,
• Organes Aucun
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SB-480848 In Subjects With Coronary Heart Disease This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease (CHD) or CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma Lp-PLA2 activity, explore the effects of SB-480848 on other circulating biomarkers associated with cardiovascular risk, and evaluate the pharmacokinetics, safety and tolerability of SB-480848 over 12 weeks of once-daily oral dosing. Subjects will first be randomized 1:1 to double-blind atorvastatin 20 mg or 80 mg once daily for a minimum of 3 weeks. Subjects will then be randomized 1:1:1:1 to oral doses of SB-480848 40 mg, 80 mg, 160 mg or placebo once daily for 12 weeks. Blood samples will be collected at various timepoints. Vital signs, electrocardiograms, clinical laboratory safety tests and adverse event assessments will be performed to evaluate the safety and tolerability of SB-480848.

• Pays Argentina, Australia, Bulgaria, Canada, Denmark, Estonia, France, Germany, Hungary, India, Netherlands, New Zealand, Pakistan, Romania, Spain, United States,
• Organes Aucun
• Spécialités Aucun

Therapy of Complicated Intra-Abdominal Infections With Moxifloxacin or Ertapenem A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.

• Pays Argentina, Belgium, Bulgaria, Estonia, France, Germany, Greece, Israel, Latvia, Lithuania, Romania, Russian Federation, South Africa, Spain,
• Organes Aucun
• Spécialités Aucun

A Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and sorafenib.

• Pays Argentina, Bulgaria, Canada, Chile, Czech Republic, France, Hungary, India, Italy, Poland, Romania, Russian Federation, Serbia, Ukraine, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun