ICARIOS: 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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00232297

Collaborator

(none)

153

Enrollment

Locations

Duration (Months)

19.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmia Tachycardia, Ventricular Ventricular Fibrillation	Drug: SSR149744C	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

153 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

Primary Outcome Measures

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

Time to all arrhythmia episodes leading to at least one documented ICD shock. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey	United States	08807
2	Sanofi-Aventis Administrative Office	Diegem		Belgium
3	Sanofi-Aventis Administrative Office	Laval		Canada
4	Sanofi-Aventis Administrative Office	Praha		Czech Republic
5	Sanofi-Aventis Administrative Office	Berlin		Germany
6	Sanofi-Aventis Administrative Office	Milano		Italy
7	Sanofi-Aventis Administrative Office	Gouda		Netherlands
8	Sanofi-Aventis Administrative Office	Geneva		Switzerland