Status:
COMPLETED
EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)
Lead Sponsor:
Sanofi
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief 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/AF...
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-do...
Eligibility Criteria
Inclusion
- Patients of either sex aged 21 years or more, in sinus rhythm for at least 1 hour at the time of randomization and with at least one ECG-documented AF/AFL episode in the last 3 months.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2003
Estimated Enrollment :
615 Patients enrolled
Trial Details
Trial ID
NCT00259428
Start Date
November 1 2001
End Date
August 1 2003
Last Update
February 9 2010
Active Locations (12)
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1
Sanofi-Aventis Administrative Office
Diegem, Belgium
2
Sanofi-Aventis Administrative Office
Prague, Czechia
3
Sanofi-Aventis Administrative Office
Hørsholm, Denmark
4
Sanofi-Aventis Administrative Office
Helsinki, Finland