EUCTR2007-001643-21-GB进行中（未招募）1 期
se of endothelin-1 antagonists in patients with Established Pulmonary Hypertension and Fibrotic Lung Disease. – A randomised, placebo-controlled, double-blinded study. - Tracleer in Interstitial Lung Disease and Pulmonary Hypertension
Royal Brompton and Harefield NHS Trust0 个研究点目标入组 48 人开始时间: 2007年10月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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
入选标准
- •1. Patients >=18yrs, <80yrs
- •2. Patients with Idiopathic Pulmonary Fibrosis according to ATS/ERS criteria.
- •3. Patients with pulmonary hypertension on right heart catheter (mean pulmonary arterial pressure >25mmHg with pulmonary artery occlusion pressure, left atrial pressure or left ventricular end-diastolic pressure <15mmHg).
- •4. Patients providing written informed consent.
- •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
- •1. Patients <18, >80yrs.
- •2. Patients with unstable disease, or an acute exacerbation of their underlying fibrotic lung disease.
- •3. Patients with significant other organ co-morbidity including hepatic or renal impairment.
- •4. Patients with systolic BP < 85mmHg
- •5. Patients with other conditions that may affect the ability to perform a 6-minute walk test.
- •6. Patients unable to provide informed consent and comply with the patient protocol.
- •7. Patients receiving excluded medications (including: epoprostenol, or prostacyclin analogues, phosphodiesterase inhibitors, other endothelin receptor antagonists, drugs with potential interaction with bosentan such as glibenclamide, fluconazole, cyclosporin A, or tacrolimus, and other invesgational agents).
- •8. Patients with planned surgical intervention during the study period.
- •9. Pregnant patients or patients of child bearing capacity who are using a reliable contraceptive method.
- •10. Patients with clinically overt ischaemic heart disease
- •11. Patients with predominant emphysema on CT scan (greater than interstitial changes)
研究者
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