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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

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.