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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Atrial Fibrillation, Atrial Flutter

Intervention / Treatment
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* Drug: CELIVARONE (SSR149744C)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 21 years or more of either sex with documented sinus rhythm for at least 1 hour at the time of randomization with at least one ECG-documented AF/AFL episode in the last 3 months. Exclusion Criteria: MAIN CRITERIA (non-exhaustive list):Women of childbearing potential without adequate birthcontrol, Pregnant Women, Breastfeeding women, contraindications to amiodarone, conditions which increase the risk of severe antiarrhythmic drug side effects, severe left ventricular dysfunction, severe associated conditions.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CELIVARONE (SSR149744C)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the time from randomization to first documented AF/AFL recurrence indicated by 12-lead ECG or trans-telephonic ECG monitoring tracings showing AF/AFL. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoints will be the following:time from randomization to first symptomatic AF/AFL recurrence - mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Atrial Flutter, Arrhythmia, Anti-Arrhythmia Agents