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

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: February 2007

Interventions Used in this Clinical Trial

  • Drug: SSR149744C

Outcome Measures for this Clinical Trial

Primary 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 Measures

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

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • ICD CSD, Study Director, Sanofi

Citations Reporting on Results

Gojkovic O, Aliot EM, Capucci A, Connolly SJ, Crijns H, Hohnloser SH, Kulakowski P, Roy D, Radzik D, Singh BN, Kowey PR. Celivarone in patients with an implantable cardioverter-defibrillator: adjunctive therapy for the reduction of ventricular arrhythmia-triggered implantable cardioverter-defibrillator interventions. Heart Rhythm. 2012 Feb;9(2):217-224.e2. doi: 10.1016/j.hrthm.2011.09.073. Epub 2011 Oct 4.


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