Status:
COMPLETED
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
Lead Sponsor:
Sanofi
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
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
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 eff...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00232310
Start Date
October 1 2005
End Date
April 1 2006
Last Update
May 8 2012
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Laval, Canada
3
Sanofi-Aventis Administrative Office
Prague, Czechia
4
Sanofi-Aventis Administrative Office
Paris, France