NL-OMON40399已完成3 期
AMB115811: A randomised, multicentre, double-blind, placebo-controlled study of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - AMB115811
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Age 18-80 year.
- •* Inoperable CTEPH (see protocol page 19 for details).
- •* mPAP > 25 mmHg, PVR > 400 dynes.sec/cm5 and PCWP or LVEDP < 15 mmHg.
- •* Distance during 6 minutes walk test 150-475 meters.
- •* WHO class II or III.
- •* SaO2 at least 92% (pulse oximetry).
- •* Anticoagulation for a minimum of 3 months.
- •* Females of childbearing potential: 2 reliable methods of contraception.
排除标准
- •* Previous PAH therapy (PDE5i, ERA, prostanoid (more than 7 days)) in the last 12 weeks.
- •* Any previous ERA treatment discontinued due to tolerance issues other than those associated with liver function abnormalities.
- •* Previous endarteriectomy or balloon pulmonary angioplasty.
- •* Intravenous inotropes in the last 2 weeks.
- •* Calcium Channel Blockers or statins with a dose change in the last 4 weeks.
- •* Enrolled in an exercise training program for cardiopulmonary rehabilitation in the last 12 weeks or plans to enrol during the first 16 weeks of the study (see protocol page 21 for details).
- •* BP > 180/110 mmHg or < 90/50 mmHg.
- •* Acute MI within the last 90 days.
- •* Clinically significant aortic or mitral valve disease; pericardial constriction; restrictive or congestive cardiomyopathy; life-threatening cardiac arrhythmias; significant left ventricular dysfunction; left ventricular outflow obstruction; symptomatic coronary artery disease; autonomic hypotension; fluid depletion.
- •* FEV1<70% of predicted.
- •* MBI *35.
- •* General exclusion criteria, see protocol page 22.
- •* Pregnancy or breastfeeding
研究者
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