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Sponsors and Collaborators: |
MEDA Pharma GmbH & Co. KG 3M |
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Information provided by: | MEDA Pharma GmbH & Co. KG |
ClinicalTrials.gov Identifier: | NCT00408473 |
The purpose of the study is to assess the efficacy of flecainide controlled release (CR) in the prevention of recurrent AF during 9 months of active treatment compared to placebo in patients with only one documented AF episode.
Condition | Intervention | Phase |
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Atrial Fibrillation |
Drug: Flecainide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised Double-Blind Pilot Study Comparing Flecainide CR and Placebo in the Early Treatment of Patients With a Documented First Episode of Atrial Fibrillation. |
Estimated Enrollment: | 256 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Prof E Aliot | CHU Brabois, avenue de Bourgogne, 54511 Vandoeuvre-les-Nancy. FRANCE |
Study ID Numbers: | 1556-FLEC |
Study First Received: | December 6, 2006 |
Last Updated: | February 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00408473 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Heart Diseases Flecainide Cardiovascular Agents |
Anti-Arrhythmia Agents Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Therapeutic Uses Flecainide Cardiovascular Diseases |
Cardiovascular Agents Anti-Arrhythmia Agents Atrial Fibrillation Pharmacologic Actions Arrhythmias, Cardiac |