Randomized Double Blind Trial to Evaluate the Efficacy and Safety of Dronedarone (400mg BID) Versus Amiodarone (600mg Daily for 28 Days, Then 200mg Daily Thereafter) for at Least 6 Months for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation (AF)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- Treatment Failure
研究概览
简要总结
The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.
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, Care Provider, Investigator)
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
- •Patients with documented atrial fibrillation for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the investigator and under oral anticoagulation
排除标准
- •Contraindication to oral anticoagulation
- •Patient having received amiodarone in the past whatever the date (more than a total of twenty 200 mg tablets or more than 5 days intravenous)
- •Patients known to have chronic AF, patients with atrial flutter or paroxysmal atrial fibrillation
- •Severe congestive heart failure with New-York Heart Association (NYHA) class III or IV, severe bradycardia, high degree atrio-ventricular block, ongoing potentially dangerous symptoms when in AF such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator, first degree family history of sudden cardiac death below age 50 years in the absence of coronary heart disease, significant sinus node disease without a permanent pacemaker implanted
- •History of torsades de pointes or long QT syndrome or QT- or QTc-interval ≥500 msecs before randomization
- •Treatment with other class I or III antiarrhythmic drugs which cannot be discontinued
- •Dysthyroidism or other contraindication to amiodarone
- •The above information are not intended to contain all the considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Dronedarone 400mg bid
dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg
干预措施: dronedarone (SR33589) (Drug)
Amiodarone 600mg/200mg od
over-encapsulated tablets of amiodarone 200mg (600mg daily for 28 days then 200mg daily) administered once daily (od) and matching placebo of dronedarone 400mg tablets
干预措施: amiodarone (Drug)
结局指标
主要结局
Treatment Failure
时间窗: minimum study duration is 6 months (+10 days); maximum is 15 months
The primary event is the treatment failure defined as the first recurrence of atrial fibrillation or premature study drug discontinuation for intolerance or lack of efficacy according to the investigator judgement. The primary efficacy analysis is performed on the time from first study drug intake to this primary event. The "Measured Values" table below presents the numbers of patients with the event at the end of the study period.
次要结局
- Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event(minimum study duration is 6 months (+10 days); maximum is 15 months)