Status:
COMPLETED
European Study of Dronedarone in Atrial Fibrillation
Lead Sponsor:
Sanofi
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy of dronedarone for the control of ventricular rate at rest and during exercise in patients with atrial fibrillation (AF) and to assess the tolerabil...
Eligibility Criteria
Inclusion
- Patients with symptomatic permanent AF (\>6 months) for which cardioversion is not considered and resting ventricular rate \> or equal 80 bpm at screening measured on a 6-seconds rhythm strip,
Exclusion
- Unstable angina pectoris, recent myocardial infarction or history of torsades de pointes
- Third degree atrioventricular block at the screening ECG or significant sinus node disease without a permanent pacemaker implanted
- Clinically overt congestive heart failure at randomization
- Patients treated with amiodarone, other antiarrhythmic drugs or previous participation in this trial or in other dronedarone trials or taking an investigational drug
- Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic or psychiatric disease
- Pregnant and/or breastfeeding women or women of child-bearing potential with no adequate birth control
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00697086
Start Date
August 1 2002
End Date
June 1 2004
Last Update
July 30 2009
Active Locations (9)
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1
Sanofi-aventis Administrative Office
Diegem, Belgium
2
Sanofi-aventis Administrative Office
Prague, Czechia
3
Sanofi-aventis Administrative Office
Paris, France
4
Sanofi-aventis Administrative Office
Milan, Italy