European Study of Dronedarone in Atrial Fibrillation
- Registration Number
- NCT00697086
- Lead Sponsor
- Sanofi
- 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 tolerability of dronedarone in the target population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 Dronedarone (SR33589) -
- Primary Outcome Measures
Name Time Method Change from baseline in mean ventricular rate at rest and during exercise Day 14
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanofi-aventis Administrative Office
🇨🇭Geneva, Switzerland