A Randomized, International, Multi-center, Open-label Study to Document Pharmacokinetics and Optimal Timing of Initiation of Dronedarone Treatment Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation Whatever the Reason for the Change of Treatment.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 154
- 试验地点
- 40
- 主要终点
- Plasma levels of dronedarone and its metabolite
研究概览
简要总结
Primary Objective:
- Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to different timings of Dronedarone initiation.
Secondary Objective:
- Explore potential PK interaction between Dronedarone and Amiodarone
- Evaluate the rate of Atrial Fibrillation (AF) recurrence during the study period (from randomization up to 60 days after)
- To assess the safety of the change from Amiodarone to Dronedarone and Dronedarone safety
详细描述
The maximum study duration per patient is 10 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 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
Group A
Dronedarone 400 mg twice daily for 8 weeks starting from randomization.
The last 2 months regimen of Amiodarone 200 mg/day is continued until randomization.
干预措施: Dronedarone (Drug)
Group B
Dronedarone 400 mg twice daily for 6 weeks starting 2 weeks after randomization.
The last 2 months regimen of Amiodarone 200 mg/day is continued until randomization.
干预措施: Dronedarone (Drug)
Group C
Dronedarone 400 mg twice daily for 4 weeks starting 4 weeks after randomization.
The last 2 months regimen of Amiodarone 200 mg/day is continued until randomization.
干预措施: Dronedarone (Drug)
结局指标
主要结局
Plasma levels of dronedarone and its metabolite
时间窗: At randomization (baseline), 3 hours after the first dose of dronedarone, after 1, 2 and 4 weeks of treatment with dronedarone (before dronedarone dose)
次要结局
- Plasma levels of amiodarone and its metabolite(At randomization (baseline), 3 hours after the first dose of dronedarone, after 1, 2 and 4 weeks of treatment with dronedarone (before dronedarone dose))
- Number of patients with AF recurrence(From randomization up to 60 days after)
- Number of patients with symptomatic bradycardia (Heart Rate (HR) < 50 beats per minute at rest)(Up to 8 weeks after randomization)
- Number of patients with Adverse Events of Special Interest (AESIs)(Up to 8 weeks after randomization)
- Number of patients with symptomatic tachycardia (HR > 120 beats per minute at rest)(Up to 8 weeks after randomization)