跳至主要内容
临床试验/CTRI/2012/07/002823
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

发起方
Merck Sharp and Dohme

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