Overview

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

Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
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.