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临床试验/CTRI/2010/091/003007
CTRI/2010/091/003007已完成4 期

Efficacy and safety of Ivabradine (Coralan) in the treatment of stable angina pectoris

Serdia Pharmaceuticals India Pvt Ltd Mumbai0 个研究点目标入组 300 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
300

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

  • 1) Male and female patients between 18 years to 75 years of age
  • 2) Confirmed case of Coronary Artery Disease (CAD) documented by either of the following:
  • a.History of stable angina (on treatment with anti-anginal drug for at least last 3 months prior to inclusion)
  • b.Previous myocardial infarction of > 6 months duration prior to inclusion
  • c.Positive exercise tolerance test (ETT, based on available report)
  • d.Previous revascularization of > 6 months prior to inclusion (percutaneous or surgical)
  • e.Angiographic evidence that one or more major coronary arteries had narrowed by 50% or more (ETT, based on available report)
  • 3) Given written informed consent to participate in the study and agree for regular follow-up

排除标准

  • 1) Resting heart rate below 60 beats per minute
  • 2) Heart failure
  • 3) History of myocardial infarction/ stroke of < 6 months prior to inclusion
  • 4) AV block, SA block and/or sick-sinus syndrome
  • 5) Symptomatic hypotension
  • 6) Unstable/ Prinzmetal angina
  • 7) Atrial fibrillation/ flutter, arrhythmias
  • 8) Severe hepatic abnormalities
  • 9) Intolerance and any other clinical condition likely to interfere in the study conduct
  • 10) History of drug abuse/ alcohol abuse
  • 11) Pregnancy/ Lactation

研究者

发起方
Serdia Pharmaceuticals India Pvt Ltd Mumbai

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