Kusajili – Clinical trials directory

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

• Country Canada, Denmark, France, Hungary, Israel, Korea, Republic of, Russian Federation, South Africa, Ukraine, United States,
• organs None
• Specialty None

Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.

• Country Australia, Belgium, Canada, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, South Africa, Spain, Sweden, United Kingdom, United States,
• organs None
• Specialty None

A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

• Country Australia, Austria, Czech Republic, France, Germany, Hungary, Italy, Poland, South Africa, Spain, United Kingdom,
• organs None
• Specialty None

A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.

• Country Austria, Czech Republic, Finland, France, Germany, Hungary, Poland, South Africa, Sweden, Switzerland, Turkey, United Kingdom,
• organs None
• Specialty None

Efficacy and Safety Study of 3 Thalidomide Doses for the Treatment of Relapsed Refractory Multiple Myeloma The primary objective is to compare the time to progression (TTP) of three daily doses of thalidomide (100, 200 and 400 mg) with high-dose dexamethasone in relapsed refractory multiple myeloma (MM) patients and to subsequently select the optimum thalidomide dose in terms of median TPP and toxicity.

• Country Bulgaria, Croatia, Czech Republic, France, Germany, Hungary, India, Italy, Philippines, Poland, Portugal, Serbia, Slovakia, South Africa, United Kingdom,
• organs None
• Specialty None

Study of Aripiprazole in Patients With Bipolar I Disorder The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.

• Country Australia, Bulgaria, Czech Republic, Estonia, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Russian Federation, South Africa, Spain, Switzerland, United Kingdom, United States,
• organs None
• Specialty None

Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.

• Country Australia, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Poland, Slovakia, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom,
• organs None
• Specialty None

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).

• Country 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,
• organs None
• Specialty None

Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis The primary purpose of this study is to identify an appropriate dose of study medication.

• Country Argentina, Canada, France, Hungary, Italy, Japan, Mexico, South Africa, United States,
• organs None
• Specialty None

Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

• Country Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, South Africa, Spain, Sweden,
• organs None
• Specialty None