A Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Assess the Effects of Dronedarone 400 mg BID for 12 Weeks on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 112
- 试验地点
- 92
- 主要终点
- Atrial Fibrillation (AF) Burden During the 12-week Treatment Period
研究概览
简要总结
Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a permanent pacemaker.
Secondary objectives were to evaluate:
- the effects of dronedarone on AF pattern characteristics i.e. ventricular rate during AF;
- the effects of dronedarone on subject-perceived AF burden and symptom severity as reported by subjects using the Atrial Fibrillation Severity Scale (AFSS);
- the incidence of electrical cardioversion (or overdrive pacing) during treatment;
- the safety of dronedarone.
详细描述
The maximum duration of the study period for a participant was 18 weeks (approximatively 4.5 months) including up to 4 weeks screening, 12-week Treatment period and a post-treatment follow-up of 2 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
- 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
Dronedarone
Dronedarone 400 mg twice a day for 12 weeks
干预措施: Dronedarone (Drug)
Placebo
Placebo (for Dronedarone) twice a day for 12 weeks
干预措施: Placebo (for Dronedarone) (Drug)
结局指标
主要结局
Atrial Fibrillation (AF) Burden During the 12-week Treatment Period
时间窗: Baseline (before randomization), 4 weeks and 12 weeks after randomization
AF burden, defined as the percent time a subject is in AF, was evaluated centrally by a Pacemaker Core Lab based on pacemaker interrogation reports including Electrogram (EGM) data provided by the Investigator. AF burden during the 12-week treatment period was defined as the duration-weighted average of AF burden collected at Week 4 and Week 12. It was calculated from the single available measurement when one measurement was missing.
次要结局
- AF Burden During the First 4 Weeks of Treatment and After 4-week Treatment(4 weeks and 12 weeks after randomization)
- Average Ventricular Rate During AF Episodes(Baseline (before randomization), 4 weeks and 12 weeks after randomization)
- Atrial Fibrillation Severity Scale (AFSS) Scores(Baseline (before randomization) and 12 weeks after randomization)
- Incidence Rate of Electrical Cardioversion (or Overdrive Pacing)(12 weeks)