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 (CORYFEE)
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ClinicalTrials.gov Identifier: NCT00232310 |
Recruitment Status :
Completed
First Posted : October 4, 2005
Last Update Posted : May 8, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Fibrillation Atrial Flutter | Drug: CELIVARONE (SSR149744C) | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 Start Date : | October 2005 |
Actual Primary Completion Date : | April 2006 |
Actual Study Completion Date : | April 2006 |

- 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.
- 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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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232310
United States, New Jersey | |
Sanofi-Aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Canada | |
Sanofi-Aventis Administrative Office | |
Laval, Canada | |
Czech Republic | |
Sanofi-Aventis Administrative Office | |
Praha, Czech Republic | |
France | |
Sanofi-Aventis Administrative Office | |
Paris, France | |
Germany | |
Sanofi-Aventis Administrative Office | |
Berlin, Germany | |
Hungary | |
Sanofi-Aventis Administrative Office | |
Budapest, Hungary | |
Italy | |
Sanofi-Aventis Administrative Office | |
Milano, Italy | |
Netherlands | |
Sanofi-Aventis Administrative Office | |
Gouda, Netherlands | |
Portugal | |
Sanofi-Aventis Administrative Office | |
Porto Salvo, Portugal |
Study Director: | ICD CSD | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00232310 |
Other Study ID Numbers: |
DRI5760 |
First Posted: | October 4, 2005 Key Record Dates |
Last Update Posted: | May 8, 2012 |
Last Verified: | May 2012 |
Atrial Fibrillation Atrial Flutter Electric Countershock |
Atrial Fibrillation Atrial Flutter Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes |