drugset / Trial / NCT00259376

American-Australian-African Trial With Dronedarone in Patients With Atrial Fibrillation or Atrial Flutter for the Maintenance of Sinus Rhythm

NCT00259376

Phase 3 Completed 629 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL). To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence. To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.

Timeline

Start
2001-11
Primary completion
2003-09
Completion
2003-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Dronedarone Small molecule 400 mg Oral