NCT00233441

Placebo Controlled Double-blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200 or 300 mg OD With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter

Placebo Controlled Double Blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200, or 300 mg OD, With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 673 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of AF/AFL.

Detailed description

This is a dose-ranging multicenter, multinational, randomized, double-blind, placebo-controlled, parallel arm study with 4 SSR149744C dose regimens and amiodarone as a calibrator.To be eligible, patients must be in normal sinus rhythm for at least one hour at randomization and must have an electrocardiogram documented history of recent AF/AFL reverted to normal sinus rhythm by electrical, pharmacological or spontaneous conversion.

Conditions

• Atrial Fibrillation
• Atrial Flutter

Interventions

Type	Name	Description
DRUG	CELIVARONE (SSR149744C)

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2005-10-05
• Last updated: 2012-05-08

Locations

17 sites across 17 countries: United States, Argentina, Australia, Canada, Chile, Denmark, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Russia, Spain, Sweden, Switzerland