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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00233441 |
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.
Condition | Intervention | Phase |
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Atrial Fibrillation Atrial Flutter |
Drug: SSR149744C |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Enrollment: | 673 |
Study Start Date: | December 2004 |
Study Completion Date: | May 2006 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | DRI5165 |
Study First Received: | October 4, 2005 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00233441 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Japan: Pharmaceuticals and Medical Devices Agency |
Atrial Fibrillation Atrial Flutter Arrhythmia Anti-Arrhythmia Agents |
Heart Diseases Atrial Fibrillation Amiodarone Atrial Flutter Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |