Ventricular arrhythmia MedDRA version: 14.0 Level: PT Classification code 10047281 Term: Ventricular arrhythmia System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: Celivarone
Product Code: SSR149744C
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Celivarone
CAS Number: 401925-44-8
Current Sponsor code: SSR149744C
Concentration unit: mg mil
Sponsors
Sanofi-aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (All inclusion criteria must be present for the patient to be eligible for the study): ICD patients with a LVEF of 40% or less AND one of the following criteria: •at least one ICD therapy for VT or VF in the previous month •OR ICD implantation in the previous month for documented VT/VF Signed informed consent for the study 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
Exclusion criteria: Methodology related criteria: E 01. Patients of either sex aged below 21 years (or the age of legal consent of the country), E 02. Women of childbearing potential without adequate birthcontrol (NB women must be menopaused or sterile or hysterectomized or if women of child-bearing potential they must be on adequate birth control e.g. oral contraception or Intra Uterine Device (IUD). E 03. Pregnant Women, E 04. Breastfeeding women, E 05. Previous (2 preceding months) or current participation in another clinical trial with an investigational drug (under development) or with an investigational device, E 06. Patients with known ICD lead problem (lead dislodgement) E 07. ICD without the following characteristics : •data logging function with cumulative counting of device intervention (shocks and antitachycardia pacing [ATP]) • electrogram storage capabilities • ventricular demand pacing. E 08. Recent unstable angina pectoris or myocardial infarction ( 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 E 16. Patients treated with oral amiodarone (more than 20 tablets during the 2 months preceding randomization) E 17. Patients in whom a contraindicated concomitant treatment is mandatory (class I or III antiarrhythmic agents). Criteria Related to the calibrator arm E 18. All conditions for which according to the local labelling amiodarone is contraindicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the efficacy of celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death.;Secondary Objective: The secondary objective are: •to assess the tolerability of the different dose regimens of celivarone in the selected population •to document SSR149744 plasma levels during the study.;Primary end point(s): VT/VF triggered ICD interventions (shocks or ATPs) or sudden death. | — |
Countries
Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden
Outcome results
None listed