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 (ICARIOS)

Sanofi

Status and phase

Completed

Phase 2

Conditions

Arrhythmia

Ventricular Fibrillation

Tachycardia, Ventricular

Treatments

Drug: SSR149744C

Study type

Interventional

Funder types

Industry

Identifiers

DRI5349

Details and patient eligibility

About

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.

Enrollment

153 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.