Ventricular Arrhythmia Clinical Trial
Official title:
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
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 SSR149744 plasma levels during the study.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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