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

Phase 2

Completed

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Celivarone 50 mg	Matching placebo	Celivarone, 50 mg once daily up to 10-15 days before the common study end date
Celivarone 100 mg	Celivarone	Celivarone, 100 mg once daily up to 10-15 days before the common study end date
Celivarone 100 mg	Matching placebo	Celivarone, 100 mg once daily up to 10-15 days before the common study end date
Celivarone 300 mg	Celivarone	Celivarone, 300 mg once daily up to 10-15 days before the common study end date
Celivarone 300 mg	Matching placebo	Celivarone, 300 mg once daily up to 10-15 days before the common study end date
Amiodarone	Matching placebo	Amiodarone, 600 mg once daily for 10 days (loading dose) then 200 mg once daily up to 10-15 days before the common study end date
Celivarone 50 mg	Celivarone	Celivarone, 50 mg once daily up to 10-15 days before the common study end date
Placebo	Matching placebo	Matching placebo once daily up to 10-15 days before the common study end date
Amiodarone	Amiodarone	Amiodarone, 600 mg once daily for 10 days (loading dose) then 200 mg once daily up to 10-15 days before the common study end date

Primary Outcome Measures

Name	Time	Method
Time to Ventricular Tachycardia or Ventricular Fibrillation (VT/VF) triggered ICD interventions or sudden death	up to 20 months (median follow-up of 12 months)	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.

Secondary Outcome Measures

Name	Time	Method
Time to ICD shocks (appropriate or inappropriate) or death from any cause	up to 20 months (median follow-up of 12 months)
Time to Cardiovascular hospitalization or death	up to 20 months (median follow-up of 12 months)

Locations (151): Investigational Site Number 840006
🇺🇸
Huntsville, Alabama, United States
Investigational Site Number 840042
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Mobile, Alabama, United States
Investigational Site Number 840014
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Mesa, Arizona, United States
Investigational Site Number 840032
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Phoenix, Arizona, United States
Investigational Site Number 840033
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Tucson, Arizona, United States
Investigational Site Number 840054
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Redondo Beach, California, United States
Investigational Site Number 840007
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Redwood City, California, United States
Investigational Site Number 840039
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Colorado Springs, Colorado, United States
Investigational Site Number 840002
🇺🇸
Fort Myers, Florida, United States
Investigational Site Number 840010
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Orlando, Florida, United States
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Investigational Site Number 840006
🇺🇸Huntsville, Alabama, United States