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临床试验/EUCTR2012-000215-89-IT
EUCTR2012-000215-89-IT进行中(未招募)不适用

Effects of ivabradine on vascular function in individuals at increased risk of developing cardiovascular disease and with impaired endothelial functionAn international, multicentre, randomised, double-blind, placebo-controlled study over 12 weeks.

Institut de Recherches Internationales Servier0 个研究点目标入组 340 人开始时间: 2013年4月23日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
340

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • ­- Men or postmenopausal women of any ethnic origin aged between 21 and 74 years
  • - ­In sinus rhythm with resting HR at least 75 bpm
  • - ­At increased risk of subsequent cardiovascular disease (documented by the presence of at least two cardiovascular risk factors such as diabetes, hypertension, smoking, hypercholesterolemia) and impaired FMD (<5.0%)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 270
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 70

排除标准

  • ­- Previous diagnosis of coronary heart disease
  • - Previous diagnosis of heart failure or current clinical signs or symptoms in keeping with a diagnosis of heart failure
  • - History of cerebrovascular or peripheral arterial disease
  • - Uncontrolled hypertension
  • - Chronic infectious or inflammatory disease
  • - Chronic Obstructive Pulmonary Disease (COPD) treated with inhaled bronchodilators
  • - Malignancy
  • - Current therapy with nicorandil, nitrate, insulin
  • - Contra-indication to ivabradine

研究者

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