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) - Full Text View

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)

This study has been completed.

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00232297

Purpose

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	Intervention	Phase
Arrhythmia Tachycardia, Ventricular Ventricular Fibrillation	Drug: SSR149744C	Phase II

Genetics Home Reference related topics:

Brugada syndrome short QT syndrome

MedlinePlus related topics:

Arrhythmia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Sanofi-Aventis:

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.

Estimated Enrollment:	150
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232297

Locations


United States, New Jersey
	Sanofi-Aventis
	Bridgewater, New Jersey, United States, 08807

France
	Sanofi-Aventis
	Chilly, France, 91380

Sponsors and Collaborators

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	DRI5349, SSR149744C
First Received:	October 3, 2005
Last Updated:	August 2, 2007
ClinicalTrials.gov Identifier:	NCT00232297
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Italy: The Italian Medicines Agency