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

NCT00232297

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind