NCT00232297

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	SSR149744C

Timeline

• Start date: 2005-06-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2005-10-04
• Last updated: 2012-05-08

Locations

8 sites across 8 countries: United States, Belgium, Canada, Czechia, Germany, Italy, Netherlands, Switzerland