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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 486
- 试验地点
- 151
- 主要终点
- Time to Ventricular Tachycardia or Ventricular Fibrillation (VT/VF) triggered ICD interventions or sudden death
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Celivarone 50 mg
Celivarone, 50 mg once daily up to 10-15 days before the common study end date
干预措施: Celivarone (Drug)
Celivarone 50 mg
Celivarone, 50 mg once daily up to 10-15 days before the common study end date
干预措施: Matching placebo (Drug)
Celivarone 100 mg
Celivarone, 100 mg once daily up to 10-15 days before the common study end date
干预措施: Celivarone (Drug)
Celivarone 100 mg
Celivarone, 100 mg once daily up to 10-15 days before the common study end date
干预措施: Matching placebo (Drug)
Celivarone 300 mg
Celivarone, 300 mg once daily up to 10-15 days before the common study end date
干预措施: Celivarone (Drug)
Celivarone 300 mg
Celivarone, 300 mg once daily up to 10-15 days before the common study end date
干预措施: Matching placebo (Drug)
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
干预措施: Amiodarone (Drug)
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
干预措施: Matching placebo (Drug)
Placebo
Matching placebo once daily up to 10-15 days before the common study end date
干预措施: Matching placebo (Drug)
结局指标
主要结局
Time to Ventricular Tachycardia or Ventricular Fibrillation (VT/VF) triggered ICD interventions or sudden death
时间窗: 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.
次要结局
- 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))