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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00489736 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: dronedarone (SR33589) Drug: amiodarone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Randomized Double Blind Trial to Evaluate the Efficacy and Safety of Dronedarone (400mg BID) Versus Amiodarone (600mg Daily for 28 Days, Then 200mg Daily Thereafter) for at Least 6 Months for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation (AF) |
| Enrollment: | 504 |
| Study Start Date: | June 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Dronedarone 400mg bid: Experimental
dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg
|
Drug: dronedarone (SR33589)
oral administration
|
|
Amiodarone 600mg/200mg od: Active Comparator
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
|
Drug: amiodarone
oral administration
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information are not intended to contain all the considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Show 23 Study Locations| Study Director: | International Clinical Development | Sanofi-Aventis |
More Information
| Responsible Party: | sanofi-aventis ( International Clinical Development, Clinical Study Director ) |
| Study ID Numbers: | EFC4968 |
| Study First Received: | June 20, 2007 |
| Results First Received: | September 30, 2009 |
| Last Updated: | December 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00489736 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Netherlands: Medicines Evaluation Board (MEB) |
|
Atrial Fibrillation sinus rhythm amiodarone |
|
Vasodilator Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Cardiovascular Agents Amiodarone Pharmacologic Actions |
Pathologic Processes Therapeutic Uses Cardiovascular Diseases Atrial Fibrillation Anti-Arrhythmia Agents Arrhythmias, Cardiac |