Kusajili – Centralise les essais cliniques mondiaux

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II) Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk. Secondary Objectives: - To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points - To evaluate the effect of alirocumab on other lipid parameters - To evaluate the safety and tolerability of alirocumab

• Pays Canada, Denmark, France, Hungary, Israel, Korea, Republic of, Russian Federation, South Africa, Ukraine, United States,
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CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients The aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP) patients on the disease including disease severity, clinical signs and symptoms and measures used for diagnosis in daily routine practice as well as data on Avelox® including information on the use, effectiveness, treatment outcome, safety and tolerability. As this is a non-interventional observational study, routine clinical practice is observed. The application of medications follows the normal routines and is decided by the treating physician under recognition of the package insert.

• Pays Croatia, France, Hungary, Jordan, Kazakhstan, Lebanon, Macedonia, the former Yugoslav Republic of, Moldova, Republic of, Romania, Russian Federation, Ukraine,
• Organes Aucun
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Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis The purpose of the study is to evaluate the clinical efficacy, safety and tolerability of apremilast (30 mg twice daily [BID] and 40 mg BID), compared with placebo, in subjects with active Ulcerative Colitis (UC).

• Pays Australia, Bulgaria, Canada, Czech Republic, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Russian Federation, Ukraine, United States,
• Organes Aucun
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Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis This study is an extension to the study AC-058B201 and will investigate the long-term safety, tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple sclerosis.

• Pays Austria, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States,
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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
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Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer The purpose of this study is to collect information on how effective and how well tolerated an oral investigational drug is compared to a standard intravenous drug in patients with pretreated, advanced non-small lung cancer (NSCLC).

• Pays Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Russian Federation, Singapore, South Africa, Spain, Switzerland, Taiwan, Province of China, Thailand, Turkey, Ukraine, United Kingdom,
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Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.

• Pays Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States,
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Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in patients with Schizophrenia.

• Pays Austria, Bulgaria, Czech Republic, Estonia, France, Germany, Hungary, India, Lithuania, Poland, Russian Federation, Spain, Ukraine, United States,
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FUTURE 3 Study Extension The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).

• Pays Australia, Belarus, China, Czech Republic, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, Serbia, South Africa, Spain, Ukraine, United States,
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Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) <12 years of age.

• Pays Australia, Belarus, China, Czech Republic, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, Serbia, South Africa, Spain, Ukraine, United States,
• Organes Aucun
• Spécialités Aucun