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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232297
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : May 8, 2012
Information provided by (Responsible Party):

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

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Study Type : Interventional  (Clinical Trial)
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 : June 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Primary Outcome Measures :
  1. 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 :
  1. Time to all arrhythmia episodes leading to at least one documented ICD shock.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00232297

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Laval, Canada
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Milano, Italy
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Sanofi-Aventis Administrative Office
Geneva, Switzerland
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi

Additional Information:
Publications of Results:
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Responsible Party: Sanofi Identifier: NCT00232297     History of Changes
Other Study ID Numbers: DRI5349
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012
Keywords provided by Sanofi:
Tachycardia, Ventricular
Ventricular Fibrillation
Defibrillators Implantable
Anti-arrhythmia agents
Additional relevant MeSH terms:
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Ventricular Fibrillation
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes