Atrial fibrillation/flutter MedDRA version: 7.0 Level: PT Classification code 10003658
Conditions
Interventions
Product Code: SSR149744C
Pharmaceutical Form: Capsule*
CAS Number: 401925-44-8
Current Sponsor code: SSR149744C
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
Sanofi-Synthelabo Recherche
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of AF/AFL.;Secondary Objective: To assess the efficacy of SSR149744C versus placebo on symptomatic AF/AFL recurrence and AF/AFL related symptoms. To assess versus placebo the ventricular rate during the first AF/AFL episode in the different SSR149744C groups in case of AF/AFL recurrence. To assess versus placebo the tolerability of the different dose regimens of SSR149744C. Document SSR149744C plasma levels.;Primary end point(s): Time from randomization to first documented AF/AFL recurrence indicated by 12-lead ECGs or TTEM tracings showing AF/AFL. | — |
Countries
Denmark, Germany, Hungary, Italy, Spain, Sweden
Outcome results
None listed