EUCTR2018-004393-10-GB进行中（未招募）1 期
A randomised, double-blind, placebo-controlled, cross-over trial of zibotentan in microvascular angina - Precision medicine with zibotentan in microvascular angina (PRIZE)
HS Greater Glasgow & Clyde0 个研究点目标入组 356 人开始时间: 2019年11月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 356
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
- •1.Age =>18 years.
- •2.Microvascular angina1.
- •3.Able to comply with study procedures.
- •4.Written informed consent.
- •FOR OPTIONAL MRI SUB-STUDY
- •1.Participation in the main study.
- •2.Able to comply with the sub-study procedures
- •3.Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 178
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 178
排除标准
- •1.Exercise tolerance >540 seconds in men and >430 seconds in women (i.e. actual exercise duration (s) achieved on the Bruce protocol commensurate with predicted), or, lack of anginal symptoms and/or ST-segment depression (0.1 mV) limiting exercise.
- •2.Non-cardiovascular exercise-limiting problem e.g. morbid (or severe) obesity (BMI =40.0 kg/m2)
- •3.Endothelin genotype not available
- •4.Women who are pregnant, breast-feeding or of child-bearing potential (WoCBP) without a negative pregnancy test and who are unwilling or unable to follow the reproductive restrictions defined in section 8.10 (of the study protocol) and use highly effective contraception as defined in Appendix 3 for the duration of the study treatment and 30 days after last dose of study drug.
- •5.Men who are sexually active with a WoCBP who are unwilling to use condoms or other highly effective methods of contraception for the duration of study treatment and for 14 weeks after last dose of study drug.
- •6.Heart failure (New York Heart Association Grade =II i.e. mild symptoms and slight limitation during ordinary activity)
- •7.Recent (<3 months) myocardial infarction
- •8.A history of epilepsy, other CNS adverse events, neurologic symptoms or signs consistent with spinal cord compression or CNS metastases.
- •9.Moderate or more severe renal impairment (GFR < 45 mL/min)
- •10.Liver disease with a Child-Pugh score of A (5-6 points) or higher [41]
- •11.Participation in another intervention study involving a drug within the past 90 days or 5 half-lives whichever is longer (co-enrolment in observational studies is permitted).
- •FOR OPTIONAL MRI SUB-STUDY
- •1.Implantable cardiac device i.e. pacemaker, implantable defibrillator.
- •2.Contra-indication to intravenous adenosine, i.e. asthma; chronic obstructive lung disease; decompensated heart failure; long QT syndrome; second- or third-degree AV block and sick sinus syndrome; severe hypotension.
- •3.Contra-indication to contrast media
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