Atrial Fibrillation
Conditions
Keywords
Heart disease
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.
Interventions
DRUGPlacebo
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean ventricular rate at rest and during exercise | Day 14 |
Countries
Belgium, Czechia, France, Italy, Netherlands, Poland, Spain, Sweden, Switzerland
Outcome results
None listed