A Phase III, Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of MK-6621 in Patients With Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 主要终点
- Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm
研究概览
简要总结
This study will investigate if treatment with vernakalant hydrochloride (MK-6621) results in a greater proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm compared to placebo.
详细描述
Amendment 4 of the protocol revised the planned enrollment to 123 participants and removed China as one of the countries participating in 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
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Abstinent or willing to use 2 acceptable methods of birth control
- •Patient has an atrial arrhythmia with dysrhythmic symptoms
- •Patient is receiving adequate anticoagulant therapy
- •Patient has stable blood pressure
- •Patient weighs between 45 and 136 kg (99 and 300 lbs)
- •Patient is adequately hydrated
排除标准
- •Patient is pregnant, breast-feeding, or expecting to become pregnant during the study
- •Patient routinely consumes more than 2 alcoholic drinks per day
- •Patient has known or suspected prolonged QT, familial long QT syndrome, previous Torsades de Pointes, Brugada syndrome
- •Patient has known bradycardia, advanced AV block, or sick-sinus syndrome, unless controlled by a pacemaker
- •Patient has severe aortic stenosis
- •Patient has atrial flutter
- •Patient has Class IV congestive heart failure (CHF)
- •Patient has had a myocardial infarction (MI) or acute coronary syndrome (ACS)
- •Patient has had cardiac surgery within 30 days
- •Patient has known atrial thrombus
- •Patient has reversible causes of Atrial Fibrillation
- •Patient has failed electrical cardioversion during current episode of Atrial Fibrillation
- •Patient has uncorrected electrolyte imbalance
- •Patient has clinical evidence of digoxin toxicity
- •Patient has received certain antiarrhythmic drugs or intravenous amiodarone within 7 days
- •Patient is known to be HIV positive
- •Patient has a history of cancer within the past 5 years, except for certain skin or cervical cancers
研究组 & 干预措施
vernakalant HCl
vernakalant hydrochloride
干预措施: vernakalant hydrochloride (Drug)
placebo
placebo
干预措施: Placebo to vernakalent hydrochloride (Drug)
结局指标
主要结局
Proportion of Patients With Treatment-induced Conversion of Atrial Fibrillation to Sinus Rhythm
时间窗: Within 90 minutes after first exposure
The proportion of patients with treatment-induced conversion of atrial fibrillation to sinus rhythm for a minimum duration of 1 minute
次要结局
未报告次要终点