NCT00259376

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 629 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a double-blind, parallel arm, placebo-controlled, multicentre, multinational, phase III study. To be eligible, patients must be in normal sinus rhythm at randomisation and must have an ECG-documented history of recent AF/AFL reverted to normal sinus rhythm by electrical, pharmacological or spontaneous conversion.

Conditions

• Atrial Fibrillation
• Atrial Flutter

Interventions

Type	Name	Description
DRUG	Dronedarone (SR33589)	oral administration
DRUG	placebo	oral administration

Timeline

• Start date: 2001-11-01
• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2005-11-29
• Last updated: 2010-02-15

Locations

5 sites across 5 countries: United States, Argentina, Australia, Canada, South Africa