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
NCT00232297 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153
Last updated 2012-05-08
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.
Conditions
- Arrhythmia
- Tachycardia, Ventricular
- Ventricular Fibrillation
Interventions
- DRUG
-
SSR149744C
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
ICD CSD · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-06-30
- Primary Completion
- 2007-02-28
- Completion
- 2007-02-28
Countries
- United States
- Belgium
- Canada
- Czechia
- Germany
- Italy
- Netherlands
- Switzerland
Study Locations
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