Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744c 100 or 300 mg for the Prevention of ventrICular ARrhythmia-triggered Icd interventiOnS
Phase 2
Completed
- Conditions
- ArrhythmiaTachycardia, VentricularVentricular Fibrillation
- Registration Number
- NCT00232297
- Lead Sponsor
- Sanofi
- Brief Summary
Primary objective:
* to assess the efficacy of SSR149744C for the prevention of ventricular arrhythmia-triggered ICD interventions.
Secondary objectives:
* to assess versus placebo the tolerability of the different dose regimens of SSR149744C in the selected population.
* to document SSR149744C plasma level during the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
Inclusion Criteria
- Patient 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 anti-tachycardia pacing) for ventricular tachycardia or ventricular fibrillation in the previous year.
- Left ventricular ejection fraction measured by 2D-echocardiography must have been documented to be less than 40% in the last 6 months.
Exclusion Criteria
MAIN CRITERIA (non-exhaustive list):
- Women of childbearing potential without adequate birthcontrol, Pregnant Women, Breastfeeding women, conditions which increase the risk of severe antiarrhythmic drug side effects, severe associated conditions.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Primary endpoint is time to all ventricular tachycardia or ventricular fibrillation arrhythmia leading to any ICD intervention (anti-tachycardia pacing or ICD shock).
- Secondary Outcome Measures
Name Time Method Time to all arrhythmia episodes leading to at least one documented ICD shock.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular targets and mechanisms of action of SSR149744C (Sanofi) in preventing ventricular arrhythmia-triggered ICD interventions?
How does SSR149744C compare to standard-of-care antiarrhythmics like amiodarone in reducing ICD interventions for ventricular tachycardia patients?
Which biomarkers correlate with SSR149744C efficacy in phase 2 trials for ventricular arrhythmia prevention in ICD recipients?
What are the key adverse events and management strategies for SSR149744C 100/300 mg in phase 2 trials for ventricular fibrillation prophylaxis?
Are there combination therapies involving SSR149744C and other potassium channel modulators for managing ventricular arrhythmia in ICD patients?
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇨🇭Geneva, Switzerland
Sanofi-Aventis Administrative Office🇨🇭Geneva, Switzerland