A Phase 3 interventional study of Dronedarone (SR33589) and placebo in Atrial Fibrillation and Atrial Flutter, sponsored by Sanofi. Completed at 12 sites in 12 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2010-02-09.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL).
To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.
To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence.
This is a double-blind, parallel arm, placebo-controlled, multicentre, multinational, phase III study.
To be eligible, patients must be in normal sinus rhythm at randomisation and must have an ECG-documented history of recent AF/AFL reverted to normal sinus rhythm by electrical, pharmacological or spontaneous conversion
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 615 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women of childbearing potential without adequate birth control, Pregnant women, Breastfeeding women, Congestive heart failure NYHA class III or IV, Conditions which increase the risk of severe antiarrhythmic drug side effects, Severe associated conditions.
dronedarone 400mg tablets
Drug: Dronedarone (SR33589)
matching placebo tablets
Drug: placebo
oral administration
Also known as: Multaq®
oral administration
The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence
- AF/AFL related symptoms collected at the time of ECG/TTEM recording,
- mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence (12-lead ECG or TTEM)
- time from presumed study drug near steady state defined as D5 midnight to first documented AF/AFL recurrence as indicated by ECG/TTEM recording.
This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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Sanofi