NCT00232310

Double Blind Placebo COntrolled Dose Ranging studY of the eFficacy and safEty of SSR149744c 300 or 600 mg for the Conversion of Atrial Fibrillation / fluttEr

Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744C 300 or 600 mg for the Conversion of Atrial Fibrillation / Flutter

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Double blind study to assess versus placebo the efficacy of SSR149744C for the conversion of atrial fibrillation/flutter to sinus rhythm at the time of the planned electrical cardioversion.

Detailed description

This is a dose ranging multicenter, multinational, randomized, double blind, placebo controlled, parallel arm study. Patients with AF/AFL will be randomized to one of two doses of SSR149744C. The efficacy of SSR149744C will be based on the proportion of patients converting to normal sinus rhythm at the end of the treatment period (48 hours post first dose). Patients will receive the study drug on D1 and D2. Patients not converting pharmacologically to sinus rhythm will undergo an electrical cardioversion on D3.

Conditions

• Atrial Fibrillation
• Atrial Flutter

Interventions

Type	Name	Description
DRUG	CELIVARONE (SSR149744C)

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2005-10-04
• Last updated: 2012-05-08

Locations

9 sites across 9 countries: United States, Canada, Czechia, France, Germany, Hungary, Italy, Netherlands, Portugal