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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CELIVARONE (SSR149744C) | Drug |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
MAIN CRITERIA (non-exhaustive list):
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22171925 | Result | Khitri AR, Aliot EM, Capucci A, Connolly SJ, Crijns H, Hohnloser SH, Kulakowski P, Roy D, Radzik D, Kowey PR. Celivarone for maintenance of sinus rhythm and conversion of atrial fibrillation/flutter. J Cardiovasc Electrophysiol. 2012 May;23(5):462-72. doi: 10.1111/j.1540-8167.2011.02234.x. Epub 2011 Dec 15. |
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| Laval |
| Canada |
| Sanofi-Aventis Administrative Office | Prague | Czechia |
| Sanofi-Aventis Administrative Office | Paris | France |
| Sanofi-Aventis Administrative Office | Berlin | Germany |
| Sanofi-Aventis Administrative Office | Budapest | Hungary |
| Sanofi-Aventis Administrative Office | Milan | Italy |
| Sanofi-Aventis Administrative Office | Gouda | Netherlands |
| Sanofi-Aventis Administrative Office | Porto Salvo | Portugal |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C499879 | celivarone |
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