American-Australian-African Trial With Dronedarone in Patients With Atrial Fibrillation or Atrial Flutter for the Maintenance of Sinus Rhythm (ADONIS)
Atrial Fibrillation, Atrial Flutter
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Atrial Flutter, Arrhythmia, Anti-Arrhythmia agents
Eligibility Criteria
Inclusion Criteria: Patients of either sex aged 21 years or more, in sinus rhythm for at least 1 hour at the time of randomisation and with at least one ECG-documented AF/AFL episode in the last 3 months. Exclusion Criteria: MAIN CRITERIA (non-exhaustive list, see protocol for details): 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.
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- sanofi-aventis Australia administrative office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Dronedarone 400mg bid
Placebo
dronedarone 400mg tablets
matching placebo tablets