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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The Primary objective was to assess the efficacy of Celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death.

Secondary objectives were:

• To assess the tolerability and safety of the different dose regimens of Celivarone in the selected population.

• To document Celivarone plasma levels during the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Amiodarone

Criteria

Inclusion criteria :

• Implantable Cardioverter Defibrillator (ICD) patients with a Left Ventricular Ejection Fraction (LVEF) of 40% or less AND one of the following criteria:

• at least one ICD therapy for Ventricular Tachycardia (VT) OR

• Ventricular Fibrillation (VF) in the previous month OR

• ICD implantation in the previous month for documented VT/VF

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.