Resumen

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.

Descripción detallada

The study included a one week screening period, followed by a treatment period ranging between 6 and 19 months. The treatment was to be continued until the End of Treatment visit scheduled 10-15 days prior to the common Scheduled Study End Date (SSED). The SSED was defined as about 190 days after the last patient randomization date. The expected recruitment duration was about 14 months and thus the total duration of the study about 20 months. Visits were planned to be performed at baseline, after 5 days, after 14 days, every month for 6 months and then, every three months after 6 months until the end of the study.

Elegibilidad

Edad mínima: 21 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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.

Intervenciones

drug

Celivarone

Pharmaceutical form: capsule Route of administration: oral

drug

Amiodarone

Pharmaceutical form: capsule Route of administration: oral

drug

Matching placebo

Pharmaceutical form: capsule Route of administration: oral Matching placebo added to active drug if any for a total of 3 capsules per intake

Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of Celivarone at 50, 100 or 300 mg OD With Amiodarone as Calibrator for the Prevention of ICD Interventions or Death

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Celivarone

Amiodarone

Matching placebo

Ubicaciones

Investigational Site Number 032002

Investigational Site Number 032003

Investigational Site Number 032004

Patrocinadores