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 - Icarios

• Conditions: Ventricular arrhythmia triggered ICD interventions; MedDRA version: 7.1Level: LLTClassification code 10003131

• Registration Number: EUCTR2004-004799-35-CZ
• Lead Sponsor: Sanofi-aventis recherche and developpement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-13
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients 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 ATP) for VT or VF in the previous year;
LVEF measured by 2D-echocardiography must have been documented to less than 40% in the last 6 months;
The ICD must have the following characteristics : data logging function with cumulative counting of device intervention (shocks and antitachycardia pacing [ATP]); electrogram storage capabilities; ventricular demand pacing.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Criteria related to a cardiac condition : Recent unstable angina pectoris or myocardial infarction (< 4 weeks); History of torsade de pointes; Congenital long QR syndrome; QT-interval> 500 ms on the last 12-lead ECG before randomization; Wolff-Parkinson-White syndrome; Clinically overt congestive heart failure with NYHA class III or IV at the time of randomization; Incessant sustained VT/VF
Criteria related to laboratory abnormalities
Criteria related to concomitant medication : Patients for whom the washout requirements for previous amiodarone treatment cannot be respected; Patients in whom a contraindicated concomitant treatment is mandatory; Treatment with other class I or III antiarrhythmic drugs which cannot be discontinued with the required washout period before the first study drug administration
Women of child bearing potential without adequate birth control, pregnant women and breastfeeding women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified