Placebo controlled double blind dose ranging study of the efficacy and safety of SSR149744C 50, 100, 200, or 300 mg OD, with amiodarone as calibrator for the maintenance of sinus rhythm in patients with recent atrial fibrillation/flutter.

• Conditions: Atrial fibrillation/flutter; MedDRA version: 7.0Level: PTClassification code 10003658

• Registration Number: EUCTR2004-001766-40-HU
• Lead Sponsor: Sanofi-Synthelabo Recherche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09-29
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

Patients with documented sinus rhythm for at least 1 hour at the time of randomization (two 12-lead ECGs at least 1 hour apart and both showing sinus rhythm on the day of randomization must be available);
With at least one 12-lead ECG documented AF/AFL apisode in the last 3 months.
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

Patients of either sex aged below 21 years;
Women of chibearing potential without adequate birthcontrol;
Pregnant women; Breastfeeding women.

Unstable angina pectoris;
Documented AF/AFL episode motivating inclusion in the study starting and not persisting beyond 10 days after an acute condition known to cause AF/AFL;
History of torsade de pointe;
Congenital long QT syndrome;
QT syndrome up to 500 msec;
Family history of sudden cardiac death below age 50 years in the absence of coronary heart disease;
Wolff-Parkinson-White syndrome;
History of high degree atrio-ventricular block or significant sinus node disease without a permanent pacemaker implanted.

Patients in whom amiodarone prescribed for sinus rhythm maintenance was dicontinued for inefficacy;
Patients in whom 3 or more class 1 or 3 antiarrhythmic drugs prescribed for sinus rhythm maintenance were discontinuated for inefficacy.

Clinically relevant haematologic, hepatic, gastro-intestinal, renal, pulmonary, endocrinologic or psychiatric disease.

patients for whom the washout requirements for previous amiodarone treatment cannot be respected;
Patients in whom a contra-indicated concomitant treatment is mandatory (drug which can cause torsade de pointe);
Treatment with other class 1 or 3 antiarrhythmic drugs which cannot be discontinuated with the required washout period before the first study drug administration.

Hyperthyroïdism;
Hypothyroïdism;
Other contra-indications to amiodarone.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified