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
Completed · Phase 2
Conditions studied: Arrhythmia, Tachycardia, Ventricular, Ventricular Fibrillation
In brief
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.
Key facts
- Study ID
- NCT00232297
- Run by
- Sanofi
- People needed
- 153
- Starts
- 2005-06-01
- Expected to finish
- 2007-02-01
- Last updated by the study team
- 2012-05-08
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
- Sanofi-Aventis Administrative Office — Diegem, Belgium
- Sanofi-Aventis Administrative Office — Laval, Canada
- Sanofi-Aventis Administrative Office — Prague, Czechia
- Sanofi-Aventis Administrative Office — Berlin, Germany
- Sanofi-Aventis Administrative Office — Milan, Italy
- Sanofi-Aventis Administrative Office — Gouda, Netherlands
- Sanofi-Aventis Administrative Office — Geneva, Switzerland
Full record on ClinicalTrials.gov
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