Arrhythmia Clinical Trial
— ICARIOSOfficial 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.
Status | Completed |
Enrollment | 153 |
Est. completion date | February 2007 |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Sanofi-Aventis Administrative Office | Diegem | |
Canada | Sanofi-Aventis Administrative Office | Laval | |
Czech Republic | Sanofi-Aventis Administrative Office | Praha | |
Germany | Sanofi-Aventis Administrative Office | Berlin | |
Italy | Sanofi-Aventis Administrative Office | Milano | |
Netherlands | Sanofi-Aventis Administrative Office | Gouda | |
Switzerland | Sanofi-Aventis Administrative Office | Geneva | |
United States | Sanofi-Aventis Administrative Office | Bridgewater | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
United States, Belgium, Canada, Czech Republic, Germany, Italy, Netherlands, Switzerland,
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- — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary endpoint is time to all ventricular tachycardia or ventricular fibrillation arrhythmia leading to any ICD intervention (anti-tachycardia pacing or ICD shock). | |||
Secondary | Time to all arrhythmia episodes leading to at least one documented ICD shock. |
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