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临床试验/EUCTR2006-006246-34-PL
EUCTR2006-006246-34-PL进行中(未招募)不适用

Evaluation of the anti-anginal efficacy and safety of oral administration of ivabradine compared to placebo on top of a background therapy with a calcium antagonist (amlodipine or nifedipine) in patients with stable angina pectoris.A 6-week randomised double-blind parallel-group international multicentre study.

Institut de Recherches Internationales Servier0 个研究点目标入组 1,240 人开始时间: 2008年4月3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
1,240

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

  • - Male or female aged >= 18 years,
  • - History of chronic stable angina pectoris,
  • - Normal sinus rythm,
  • - Patients having been treated by amlodipine or nifedipine for at least 4 weeks before selection,
  • - Patients with documented coronary artery disease (CAD).
  • 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 682
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 558

排除标准

  • - Recent acute myocardial infarction, coronary bypass surgery or percutaneous coronary intervention,
  • - Resting angina, unstable angina, Prinzmetal angina or microvascular angina,
  • - Patient with a pacemaker or implanted cardioverter-defibrillator,
  • - Patient who cannot perform exercise tests,
  • - Congestive heart failure stage III or IV NYHA, uncontrolled heart failure,
  • - HR < 60 bpm measured on ECG at rest at selection.

研究者

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