CTRI/2012/07/002823Other3 期
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
Merck Sharp and Dohme0 个研究点目标入组 615 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 615
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
- •-Ejection Fraction 35%.
研究者
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