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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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: AF/AFL for >72 hours and documented by 2 12-lead ECGs separated by at least 72 hours and indication for electrical cardioversion of the current AF/AFL episode as judged by the investigator. Exclusion Criteria: MAIN CRITERIA (non-exhaustive list): Women of childbearing potential without adequate birthcontrol, Pregnant Women, Breastfeeding women, conditions which increase the risk of severe antiarrhythmic drug side effects, permanent pacemaker, permanent AF/AFL, contraindication to anticoagulant, 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 efficacy endpoint is the rate of conversion to sinus rhythm documented by ECG just before the planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary efficacy endpoint will be the mean ventricular rate during AF/AFL on the 12-lead ECG performed just before the planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Atrial Flutter, Electric Countershock