NCT00993382

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 486 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arrhythmia Prophylaxis
• Ventricular Arrhythmia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-10-12
• Last updated: 2016-05-30

Locations

151 sites across 26 countries: United States, Argentina, Australia, Belgium, Canada, Chile, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, South Africa, Spain, Sweden, Turkey (Türkiye)