Kusajili – Centralise les essais cliniques mondiaux

An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.

• Pays Argentina, Canada, Chile, Croatia, France, India, Russian Federation, Ukraine, United States,
• Organes Aucun
• Spécialités Aucun

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,
• Organes Aucun
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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,
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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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• Spécialités Aucun

A Study in the Treatment of Children and Adolescents With Major Depressive Disorder The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)

• Pays France, Germany, Russian Federation, Slovakia, South Africa, Ukraine, United States,
• Organes Aucun
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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,
• Organes Aucun
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Lurasidone Extended Use Study This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.

• Pays Canada, Colombia, Czech Republic, France, India, Lithuania, Romania, Russian Federation, Serbia, Slovakia, South Africa, Ukraine,
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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,
• Organes Aucun
• Spécialités Aucun

Dose-finding Study With Lu AA24530 in Major Depressive Disorder The primary purpose of this study is to assess the efficacy in treating patients with Major Depressive Disorder of one or more doses of Lu AA24530 relative to placebo

• Pays Australia, Austria, Belgium, Canada, Czech Republic, Finland, France, India, Korea, Republic of, Lithuania, Malaysia, Norway, Philippines, Russian Federation, Serbia, Sweden, Ukraine,
• Organes Aucun
• Spécialités Aucun