NCT02021292已完成2 期
Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel-group, 24-week Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
Actelion36 个研究点 分布在 16 个国家目标入组 80 人开始时间: 2014年8月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 36
- 主要终点
- Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest.
研究概览
简要总结
Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Subject with CTEPH (WHO Group 4) judged as inoperable due to the localization of the obstruction being surgically inaccessible (i.e., distal disease).
- •Female of childbearing potential must have a negative pre-treatment serum pregnancy test, be advised on appropriate methods of contraception, and agree to use 2 reliable methods of contraception.
排除标准
- •Previous pulmonary endarterectomy.
- •Recurrent thromboembolism despite sufficient oral anticoagulants.
- •Symptomatic acute pulmonary embolism in the 6-month period prior to randomization.
- •Known moderate-to-severe restrictive lung disease (i.e., TLC < 60% of predicted value) or obstructive lung disease (i.e., FEV1 < 70% of predicted, with FEV1/FVC < 65%) or known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial lung disease, emphysema).
- •Acute or chronic conditions (other than dyspnea) that limit the ability to comply with study requirements in the 3-month period prior to Screening visit or during the Screening period.
研究组 & 干预措施
Macitentan
Experimental
Macitentan 10 mg, oral tablet, to be taken once daily.
干预措施: Macitentan (Drug)
Placebo
Placebo Comparator
Matching placebo oral tablet, to be taken once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest.
时间窗: From baseline to Week 16
The primary efficacy endpoint is defined as the PVR at rest at Week 16 expressed as percent of baseline PVR at rest.
次要结局
- Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD).(From baseline to Week 24)
- Change From Baseline to Week 24 in Borg Dyspnea Index Collected at the End of the 6-minute Walk Test (6MWT).(From baseline to Week 24)
- Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24(From baseline to Week 24)
研究者
研究点 (36)
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