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)
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00232310
First received: October 3, 2005
Last updated: May 7, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Atrial Flutter |
Drug: CELIVARONE (SSR149744C) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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:
- 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.
| Enrollment: | 150 |
| Study Start Date: | October 2005 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00232310
Locations
| 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 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD CSD | Sanofi |
More Information
Publications:
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00232310 History of Changes |
| Other Study ID Numbers: | DRI5760 |
| Study First Received: | October 3, 2005 |
| Last Updated: | May 7, 2012 |
| Health Authority: | United States: Food and Drug Administration Italy: The Italian Medicines Agency Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Sanofi:
|
Atrial Fibrillation Atrial Flutter Electric Countershock |
Additional relevant MeSH terms:
|
Atrial Fibrillation Atrial Flutter Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013