Phase 3 N=504 Randomized Triple-blind Treatment

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

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT00489736 ↗

Enrolled (actual)

504

Serious AEs

14.1%

Results posted

Nov 2009

Primary outcome: Primary: Treatment Failure — 184; 141 participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: dronedarone (SR33589) (Drug); amiodarone (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Sanofi
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Failure	184; 141	<0.0001 sig
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	83; 107	0.13

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00489736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.