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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00259428 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | EURopean Trial In Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS) |
Enrollment: | 615 |
Study Start Date: | November 2001 |
Study Completion Date: | August 2003 |
Primary Completion Date: | August 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.
Belgium | |
Sanofi-Aventis Administrative Office | |
Diegem, Belgium | |
Czech Republic | |
Sanofi-Aventis Administrative Office | |
Praha, Czech Republic | |
Denmark | |
Sanofi-Aventis Administrative Office | |
Horsholm, Denmark | |
Finland | |
Sanofi-Aventis Administrative Office | |
Helsinki, Finland | |
France | |
Sanofi-Aventis Administrative Office | |
Paris, France | |
Germany | |
Sanofi-Aventis Administrative Office | |
Berlin, Germany | |
Hungary | |
Sanofi- Aventis Administrative Office | |
Budapest, Hungary | |
Italy | |
Sanofi-Aventis Administrative Office | |
Milano, Italy | |
Netherlands | |
Sanofi-Aventis Administrative Office | |
Gouda, Netherlands | |
Poland | |
Sanofi-Aventis Administrative Office | |
Warszawa, Poland | |
Spain | |
Sanofi-Aventis Administrative Office | |
Barcelona, Spain | |
United Kingdom | |
Sanofi-Aventis Administrative Office | |
Guildford, United Kingdom |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD study director ) |
Study ID Numbers: | EFC3153, SR33589B |
Study First Received: | November 25, 2005 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00259428 History of Changes |
Health Authority: | United States: Food and Drug Administration; Germany: Ethics Commission; Denmark: Danish Medicines Agency |
Atrial Fibrillation Atrial Flutter Arrhythmia Anti-Arrhythmia agents |
Heart Diseases Anti-Arrhythmia Agents Atrial Fibrillation Atrial Flutter Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Cardiovascular Diseases |
Atrial Fibrillation Atrial Flutter Arrhythmias, Cardiac |