EUCTR2005-002456-18-SK进行中（未招募）1 期
A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PRELIMINARY EFFICACY OF A FOUR-WEEK TREATMENT WITH YM758 IN SUBJECTS WITH STABLE ANGINA. - IRIS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
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 and older, 75 y. and younger
- •- at least 3 months chronic stable effort induced angina relieved by rest or
- •nitroglycerin
- •- analysable ST segment on 12-lead ECG
- •- heart rate 5O bpm. and more at rest
- •- two positive reproductible exercise tolerance tests during the screening period and on Day 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- unstable angina, rest angina, Prinzmetal angina, significant valvular and pericardial disease, history or presence of atrial fibrillation (flutter, sick sinus syndrome, 2nd or 3rd degree atrioventricular block, congestive heart failure NYHA class III-IV.
- •- current use of antifungal medication except of short acting nitrates
- •- current use if drugs that should interfere with ST-segment changes
- •- current use of CYP3A4 inhibitors and inducers
- •- history or presence of clinically relevant ophtalmologic diseases
- •- impaired liver or renal functions
- •- uncontrolled intercurrent illness
研究者
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