Status:
COMPLETED
American-Australian-African Trial With Dronedarone in Patients With Atrial Fibrillation or Atrial Flutter for the Maintenance of Sinus Rhythm
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 randomisation 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 :
September 1 2003
Estimated Enrollment :
629 Patients enrolled
Trial Details
Trial ID
NCT00259376
Start Date
November 1 2001
End Date
September 1 2003
Last Update
February 15 2010
Active Locations (5)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
sanofi-aventis Australia administrative office
Macquarie Park, Australia
4
Sanofi-Aventis Administrative Office
Laval, Canada