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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
486
Pharmaceutical form: capsule Route of administration: oral
Pharmaceutical form: capsule Route of administration: oral
Pharmaceutical form: capsule Route of administration: oral Matching placebo added to active drug if any for a total of 3 capsules per intake
Time to Ventricular Tachycardia or Ventricular Fibrillation (VT/VF) triggered ICD interventions or sudden death
The presence of VT or VF was documented by ICD interrogation leading to any ICD interventions (shocks or anti-tachycardia pacing). The 10 first ICD interventions for each patient were centrally and blindly adjudicated by an Adjudication Committee.
Time frame: up to 20 months (median follow-up of 12 months)
Time to ICD shocks (appropriate or inappropriate) or death from any cause
Time frame: up to 20 months (median follow-up of 12 months)
Time to Cardiovascular hospitalization or death
Time frame: up to 20 months (median follow-up of 12 months)
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Investigational Site Number 840006
Huntsville, Alabama, United States
Investigational Site Number 840042
Mobile, Alabama, United States
Investigational Site Number 840014
Mesa, Arizona, United States
Investigational Site Number 840032
Phoenix, Arizona, United States
Investigational Site Number 840033
Tucson, Arizona, United States
Investigational Site Number 840054
Redondo Beach, California, United States
Investigational Site Number 840007
Redwood City, California, United States
Investigational Site Number 840039
Colorado Springs, Colorado, United States
Investigational Site Number 840002
Fort Myers, Florida, United States
Investigational Site Number 840010
Orlando, Florida, United States
...and 141 more locations