Atrial Fibrillation MedDRA version: 9.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation
Conditions
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with documented AF for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the Investigator and receiving anticoagulants, - Signed informed consent for the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients aged below 21 years, - Contraindication to oral anticoagulation, - Patient having received amiodarone in the past whatever the date (more than a total of twenty 200 mg tablets or more than 5 days intravenous [IV]), - Women of childbearing potential without adequate birthcontrol; pregnant women; breastfeeding women, - Clinically relevant haematologic, hepatic, gastrointestinal, renal, pulmonary, endocrinologic, psychiatric, neurological or dermatological disease, - Serum potassium 5.5 mmol/l before randomization, - History of torsades de pointes; first degree family history of sudden cardiac death below age 50 years in the absence of coronary heart disease, - History of high degree atrio-ventricular block (2nd degree Mobitz 2 or higher), or significant sinus node disease (documented pause of 3 sec or more) without a permanent pacemaker implanted, - Bradycardia or = 500 msecs before randomization, - Wolff-Parkinson-White Syndrome, - Patients with atrial flutter; patients with paroxysmal AF, - Hyperthyroidism; hypothyroidism; other contraindications to amiodarone, - Treatment with other Class I or III antiarrhythmic drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that dronedarone is superior to amiodarone in the maintenance of sinus rhythm after pharmacological, electrical or spontaneous conversion of AF.;Secondary Objective: To evaluate the safety of dronedarone versus amiodarone.;Primary end point(s): Treatment failure defined as recurrence of AF or premature study drug discontinuation for intolerance or lack of efficacy. | — |
Countries
Austria, Belgium, Czech Republic, Estonia, Finland, Germany, Italy, Netherlands, Poland, Sweden
Outcome results
None listed