The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.
- Dronedarone (Multaq)Drug
Intervention Desc: Mainly for the indication of cardiac arrhythmias (irregular heartbeat).
- amiodarone Drug
Intervention Desc: oral administration ARM 1: Kind: Experimental Label: Amiodarone 600mg/200mg od Description: over-encapsulated tablets of amiodarone 200mg (600mg daily for 28 days then 200mg daily) administered once daily (od) and matching placebo of dronedarone 400mg tablets
- Dronedarone (SR33589) Drug
Other Names: Multaq® Intervention Desc: oral administration ARM 1: Kind: Experimental Label: Dronedarone 400mg bid Description: dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
Patients will be randomized to one of two arms 1)Experimental arm and given dronedarone (SR33589) 400mg bid or 2) Active Comparator and given amiodarone 600mg daily for 28 days, then 200mg daily. Patients are then followed for 6 months to evaluate outcomes.
|Type||Measure||Time Frame||Safety Issue|
|Primary||The primary efficacy endpoint is treatment failure defined as recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy.|
|Secondary||The main safety endpoint is occurrence of Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye or Gastrointestinal specific events or premature study drug discontinuation following any adverse event.|
|Primary||Treatment Failure||minimum study duration is 6 months (+10 days); maximum is 15 months||No|
|Secondary||Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event||minimum study duration is 6 months (+10 days); maximum is 15 months||Yes|
- Sanofi-Aventis Lead