EUCTR2013-001759-10-BE进行中（未招募）1 期
An open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
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 patients (18 -75 years of age) with idiopathic, heritable, drug/toxin induced PAH or associated PAH due to congenital heart disease (i.e. atrial septal defects if corrected for more than 12 months) demonstrating insufficient response to treatment with PDE-5i for at least 3 months
- •Patients with and without endothelin receptor antagonist (ERA) therapy
- •World Health Organization Functional Class (WHO FC) III at screening
- •6-minute walking distance of 165-440 m
- •Cardiac index <3.0 L/min/m2.
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •All types of PH except subtypes of Dana Point Group I specified in the inclusion criteria
- •Evidence of clinically significant restrictive or obstructive parenchymal lung diseases in the judgment of the investigator (e.g. based on a clean CT lung scan).
- •Diffusing capacity of the lung for carbon monoxide (DLCO) <30% predicted
- •History or active state of serious hemoptysis / pulmonary hemorrhage including those managed by bronchial artery embolization
- •Patients unable to perform a valid 6MWD test
- •Pregnant women (i.e. positive pregnancy test or other signs of pregnancy), or breast feeding women, or women with childbearing potential not using a combination of 2 effective methods of birth control
研究者
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