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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: November 25, 2005
Last updated: February 12, 2010
Last verified: February 2010

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.

Condition Intervention Phase
Atrial Fibrillation
Atrial Flutter
Drug: Dronedarone (SR33589)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: American-Australian-African Trial With Dronedarone in Atrial Fibrillation or Flutter Patients for the Maintenance of Sinus Rhythm (ADONIS)

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence

Secondary Outcome Measures:
  • - AF/AFL related symptoms collected at the time of ECG/TTEM recording,
  • - mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence (12-lead ECG or TTEM)
  • - time from presumed study drug near steady state defined as D5 midnight to first documented AF/AFL recurrence as indicated by ECG/TTEM recording.

Enrollment: 629
Study Start Date: November 2001
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dronedarone 400mg bid
dronedarone 400mg tablets
Drug: Dronedarone (SR33589)
oral administration
Other Name: Multaq®
Experimental: Placebo
matching placebo tablets
Drug: placebo
oral administration

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.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients of either sex aged 21 years or more, in sinus rhythm for at least 1 hour at the time of randomisation and with at least one ECG-documented AF/AFL episode in the last 3 months.

Exclusion Criteria:

  • MAIN CRITERIA (non-exhaustive list, see protocol for details):

Women of childbearing potential without adequate birth control, Pregnant women, Breastfeeding women, Congestive heart failure NYHA class III or IV, Conditions which increase the risk of severe antiarrhythmic drug side effects, Severe associated conditions.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00259376

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
sanofi-aventis Australia administrative office
Macquarie Park, Australia
Sanofi-Aventis Administrative Office
Laval, Canada
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Sponsors and Collaborators
Study Director: ICD CSD Sanofi
  More Information

Responsible Party: International Clinical Development, Clinical Study Director, Sanofi-aventis Identifier: NCT00259376     History of Changes
Other Study ID Numbers: EFC4788  SR33589B 
Study First Received: November 25, 2005
Last Updated: February 12, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Sanofi:
Atrial Fibrillation
Atrial Flutter
Anti-Arrhythmia agents

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors processed this record on October 21, 2016