Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

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)”

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.

Intervention(s) in this Clinical Trial

• Drug: dronedarone (SR33589)
  • oral administration
• Drug: amiodarone
  • oral administration

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Dronedarone 400mg bid
  • dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg
• Active Comparator: Amiodarone 600mg/200mg od
  • 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

Primary Measures

• Treatment Failure
  • Time Frame: minimum study duration is 6 months (+10 days); maximum is 15 months
    Safety Issue?: No

Secondary Measures

• 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
  • Time Frame: minimum study duration is 6 months (+10 days); maximum is 15 months
    Safety Issue?: Yes

Inclusion Criteria:

• Patients with documented atrial fibrillation for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the investigator and under oral anticoagulation

Exclusion Criteria:

• Contraindication to oral anticoagulation
• Patient having received amiodarone in the past whatever the date (more than a total of twenty 200 mg tablets or more than 5 days intravenous)
• Patients known to have chronic AF, patients with atrial flutter or paroxysmal atrial fibrillation
• Severe congestive heart failure with New-York Heart Association (NYHA) class III or IV, severe bradycardia, high degree atrio-ventricular block, ongoing potentially dangerous symptoms when in AF such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator, first degree family history of sudden cardiac death below age 50 years in the absence of coronary heart disease, significant sinus node disease without a permanent pacemaker implanted
• History of torsades de pointes or long QT syndrome or QT- or QTc-interval ≥500 msecs before randomization
• Treatment with other class I or III antiarrhythmic drugs which cannot be discontinued
• Dysthyroidism or other contraindication to amiodarone
• The above information are not intended to contain all the considerations relevant to a patient's potential participation in a clinical trial.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

International Clinical Development Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00489736

Study ID Number: EFC4968

ClinicalTrials.gov Identifier: NCT00489736

Health Authority: United States: Food and Drug Administration