Kusajili – Centralise les essais cliniques mondiaux

Pediatric Epilepsy Trial in Subjects 1-24 Months This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older.

• Pays Australia, Estonia, France, Hungary, Italy, Latvia, Lebanon, Lithuania, Netherlands, Portugal, Slovakia, Spain, Turkey, United States,
• Organes Aucun
• Spécialités Aucun

Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.

• Pays Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czech Republic, Estonia, Finland, France, Germany, Italy, Korea, Republic of, Mexico, Morocco, Netherlands, Poland, Russian Federation, Sweden, Tunisia, Turkey, United States,
• Organes Aucun
• Spécialités Aucun

4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures The purpose of this study is to determine the safety of perampanel given as adjunctive, long-term treatment in patients with refractory partial onset seizures.

• Pays Australia, Belgium, Czech Republic, Estonia, Finland, France, Germany, Latvia, Lithuania, Netherlands, Spain, Sweden, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

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

SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.

• Pays Australia, Czech Republic, Estonia, France, Germany, India, Italy, Lithuania, Malaysia, Netherlands, Poland, Portugal, South Africa, Spain, Taiwan, Province of China, Thailand, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

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.

• Pays Australia, Bulgaria, Czech Republic, Estonia, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Russian Federation, South Africa, Spain, Switzerland, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773

• Pays Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Lebanon, Netherlands, Norway, Sweden, United States,
• Organes Aucun
• Spécialités Aucun