Ventricular arrhythmia triggered ICD interventions MedDRA version: 7.1 Level: LLT Classification code 10003131
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
Other descriptive name: NA
Concentration unit:
Sponsors
Sanofi-aventis recherche and developpement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with an ICD implanted during the previous year for documented spontaneous life-threatening ventricular arrhythmia or implanted with an ICD and with at least one appropriate ICD therapy (shock or ATP) for VT or VF in the previous year; LVEF measured by 2D-echocardiography must have been documented to less than 40% in the last 6 months; The ICD must have the following characteristics : data logging function with cumulative counting of device intervention (shocks and antitachycardia pacing [ATP]); electrogram storage capabilities; ventricular demand pacing. 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: Criteria related to a cardiac condition : Recent unstable angina pectoris or myocardial infarction ( 500 ms on the last 12-lead ECG before randomization; Wolff-Parkinson-White syndrome; Clinically overt congestive heart failure with NYHA class III or IV at the time of randomization; Incessant sustained VT/VF Criteria related to laboratory abnormalities Criteria related to concomitant medication : Patients for whom the washout requirements for previous amiodarone treatment cannot be respected; Patients in whom a contraindicated concomitant treatment is mandatory; Treatment with other class I or III antiarrhythmic drugs which cannot be discontinued with the required washout period before the first study drug administration Women of child bearing potential without adequate birth control, pregnant women and breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of SSR149744C for the prevention of ventricular-arrhythmia triggered ICD interventions;Secondary Objective: To assess versus placebo the tolerability of the different dose regimens of SSR149744C; To document SSR149744C plasma levels;Primary end point(s): The primary efficacy endpoint will be the time from randomization to all VT or VF arrhythmia episodes (documented by ICD interrogation including stored electrograms (EGMs) leading to any ICD intervention (ATP or ICD shock) | — |
Countries
Czech Republic, Germany, Italy
Outcome results
None listed