Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death

Exclusion Criteria

• •Patients of either sex aged below 21 years (or the age of legal consent of the country),
• •Women of childbearing potential without adequate birth control or pregnant or breastfeeding women
• •Patients with known ICD lead problem (lead dislodgement)
• •ICD without the following characteristics :
• •* data logging function with cumulative counting of device intervention (shocks and anti-tachycardia pacing \[ATP\])
• •* electrogram storage capabilities
• •* ventricular demand pacing.
• •Recent unstable angina pectoris or myocardial infarction (\< 4 weeks),
• •History of torsades de pointes,
• •Genetic channelopathies including congenital long QT syndrome,
• •Wolff-Parkinson-White syndrome,
• •Patients in unstable hemodynamic condition such as acute pulmonary edema within 12 hours prior to start of study medication; cardiogenic shock; treatment with intravenous pressor agents; patients on respirator; congestive heart failure of stage New York Heart Association (NYHA) IV within the last 4 weeks; uncorrected, hemodynamically significant primary obstructive valvular disease; hemodynamically significant obstructive cardiomyopathy; a cardiac operation or revascularization procedure within 4 weeks preceding randomization,
• •Incessant sustained VT/VF (VT/VF that recurs promptly despite termination attempts) during the three days preceding randomization.
• •Patients with inappropriate (not triggered by VT nor VF) shocks during the month preceding randomization.
• •Clinically relevant haematologic, hepatobiliary (ALT, AST \> 3 times the upper limit of normal at randomization), gastro-intestinal, renal (serum creatinine \> 221 µmol/l (2.5 mg/dl) at randomization), pulmonary, endocrinologic or psychiatric disease.
• •Patients treated with oral amiodarone (more than 20 tablets during the 2 months preceding randomization)
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.