Atrial fibrillation/flutter MedDRA version: 7.1 Level: LLT Classification code 10003658
Conditions
Interventions
Product Name: NA
Product Code: SSR149744C
Pharmaceutical Form: Capsule*
INN or Proposed INN: NA
CAS Number: 401925-44-8
Current Sponsor code: SSR149744C
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Sanofi-Synthelabo-Recherche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - AF/AFL for >72 hours and documented by 2 12-lead ECG recorded prior to randomization, separated by at least 72 hours and both showing AF/AFL - Indication for cardioversion of the current AF/AFL episode as judged by the investigator 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: -Women of childbearing potential without adequat birthcontrol, pregnant women and breastfeeding women. -Contraindication to oral anti-coagulant Criteria related to a cardiac condition or a disease resistance : -Permanent cardiac pacemaker or ICD -Unstable angina pectoris or recent myocardial infarction -Acute condition known to cause AF/AFL -History of torsades de pointes -Congenital long QT syndrome -QT-interval > 500 msec on the last 12-lead ECG before randomization -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 -PR-interval ³ 0.28 sec -Significant sinus node disease -Bradycardia < 50 bpm on the last 12-lead ECG before randomization -Clinically overt congestive heart failure with NYHA class III or IV at the time of randomization, -Left ventricular ejection fraction less than 35% on the screening 2D-echocardiogram -Ongoing potentially dangerous symptoms when in AF/AFL such as angina pectoris, transient ischemic attacks, stroke, syncope as judged by the investigator -Patients known to have permanent AF/AFL -Patients in whom 3 (on different days) consecutive electrical cardioversions were unsuccessful in re-establishing sinus rhythm. Other exclusion criteria : related to clinically relevant laboratory abnormalities and related to some concommitant medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess versus placebo the efficacy of SSR149744C for the conversion of atrial fibrillation/flutter to sinus rhythm at the time of the planned electrical cardioversion.;Secondary Objective: -To assess versus placebo the efficacy of SSR149744C for the control of ventricular rate in patients not converted at the time of the planned electrical cardioversion. -To assess versus placebo the tolerability of the different dose regimens of SSR149744C in the selected population. -To document SSR149744C plasma levels during the study. ;Primary end point(s): Rate of conversion to sinus rhythm documented by ECG at the time of planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration. | — |
Countries
Czech Republic, Hungary, Italy, Portugal
Outcome results
None listed