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Sponsored by: |
Sanofi-Aventis |
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00259376 |
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 |
ChemIDplus related topics: | Dronedarone |
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) |
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) |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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.
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 |
Sanofi-Aventis |
Study Director: | ICD CSD | Sanofi-Aventis |
Related Info 
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Study ID Numbers: | EFC4788, SR33589B |
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 |
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