Status:
COMPLETED
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
Lead Sponsor:
Sanofi
Conditions:
Arrhythmia
Tachycardia, Ventricular
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00232297
Start Date
June 1 2005
End Date
February 1 2007
Last Update
May 8 2012
Active Locations (8)
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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
Prague, Czechia