EUCTR2014-001008-23-GB进行中（未招募）1 期
Riociguat in patients with respiratory disease and hypoxia – a proof-of-concept study - RIOPRED
The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital0 个研究点目标入组 12 人开始时间: 2014年8月27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
- 12
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
- •Age 40 to 80 years, Male and Female
- •Primary diagnosis of either chronic obstructive pulmonary disease (COPD) or pulmonary fibrosis (PF) with recent stability
- •Capacity and willingness to provide fully informed consent for participation in the study
- •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 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •On prescribed nitrates (tablets or sublingual), dipyridamole, theophylline, warfarin, clopidogrel, rivaroxaban and dabigatran
- •Other concomitant respiratory diagnoses including asthma, pulmonary hypertension (of any other aetiology), lung cancer, recent respiratory infection, recent acute pulmonary embolism, recent pneumothora
- •Unable to give written, informed consent
- •Contraindication to spirometry not included elsewhere: recent eye surgery, glaucoma
- •Uncontrolled arterial hypertension (systolic BP > 180mmHg and/or diastolic BP > 110mmHg
- •Systolic BP < 95mmHg
- •Resting awake heart rate < 50 beats per minute or > 105bpm
- •History of uncontrolled atrial fibrillation within 3 months of screening
- •Left heart failure with an ejection fraction less than 40%
- •Hypertrophic Obstructive Cardiomyopathy (HOCM)
- •Proven or suspected active or recent* coronary artery disease
- •Other active atherosclerotic disease: active peripheral arterial disease, stroke within 3 months of screening
- •Significant valvular heart disease
- •History of active or serious haemoptysis/pulmonary haemorrhage
- •Hepatic dysfunction
- •Bilirubin > 2 times ULN at screening and/or
- •ALT or AST > 3 times ULN at screening and/or
- •Albumin < 32g/L/hepatic encephalopathy > grade 1 at screening
- •Renal insufficiency: GFR < 30ml/min
- •Pregnant or lactating women.
研究者
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