American-Australian-African Trial With DronedarONe In AF or AFL Patients for the Maintenance of Sinus Rhythm (ADONIS) - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00259376

Purpose

To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of 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 III

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia

Drug Information available for: Dronedarone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	American-Australian-African Trial With DronedarONe In Atrial Fibrillation or Flutter Patients for the Maintenance of Sinus Rhythm (ADONIS)

Further study details as provided by Sanofi-Aventis:

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:	625
Study Start Date:	November 2001
Study Completion Date:	September 2003
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259376

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Australia
sanofi-aventis Australia administrative office
Macquarie Park, Australia
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications of Results:

Singh BN, Connolly SJ, Crijns HJ, Roy D, Kowey PR, Capucci A, Radzik D, Aliot EM, Hohnloser SH; EURIDIS and ADONIS Investigators. Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med. 2007 Sep 6;357(10):987-99.

Study ID Numbers:	EFC4788, SR33589B
Study First Received:	November 25, 2005
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00259376
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Sanofi-Aventis:

Atrial Fibrillation
Atrial Flutter
Arrhythmia
Anti-Arrhythmia agents

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009