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

Sanofi153 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

153

Conditions

Arrhythmia Tachycardia, Ventricular Ventricular Fibrillation

Interventions

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.