JPRN-jRCT2051200150暂停3 期
A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension
akano Masayoshi0 个研究点目标入组 144 人开始时间: 2021年3月11日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 144
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
- >= 18age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •Chronic thromboembolic pulmonary hypertension (CTEPH) (World Health Organization [WHO] Group 4) fulfilling one of the following criteria:
- •a) inoperable due to the localization of the obstruction being surgically inaccessible (that is, distal disease),
- •b) persistent/recurrent CTEPH after balloon pulmonary angioplasty (BPA), and deemed inoperable due to the localization of the obstruction being surgically inaccessible (that is, distal disease),
- •c) persistent/recurrent CTEPH after rescue pulmonary endarterectomy (PEA)
- •- 6-minute walk distance (6MWD) greater than or equal to (>=) 100 meter (m) and less than or equal to (<=) 450 meters (m), documented by an eligibility and a baseline 6-minute walk test (6MWT). The baseline 6MWD must not differ by more than 15 percent (%) from the eligibility test
- •- World Health Organization functional class (WHO FC) >= II
- •- Participants are to receive riociguat as per local standard of care, unless it is contraindicated or unavailable
排除标准
- •- Acute pulmonary embolism within 3 months prior to or during Screening
- •- Planned balloon pulmonary angioplasty (BPA) during the fixed duration part of the double-blind period
- •- Significant obstructive and restrictive lung disease
- •- Acute or chronic conditions (other than dyspnea) that limit the ability to comply with study requirements, in particular with 6MWT (for example, intermittent claudication).
- •- Symptomatic coronary artery disease requiring an intervention within 3 months prior to or during Screening or anticipated during the fixed duration part of the study
- •- Decompensated cardiac failure if not under close supervision
- •- Known and documented life-threatening cardiac arrhythmias
- •- Acute myocardial infarction within 6 months prior to, or during Screening
- •- Cerebrovascular events (including transient ischemic attack) within 3 months prior to, or during Screening
- •- Known or suspicion of pulmonary veno-occlusive disease (PVOD)
- •- Administration of ERAs, intravenous prostacyclins / prostacyclin analogs, or investigational treatment within 90 days prior to Randomization
- •- Change in dose or initiation of Phosphodiesterase type-5 (PDE-5) inhibitors, oral, inhaled or subcutaneous (SC) prostacyclins / prostacyclin analogues, prostacyclin receptor agonists or riociguat,
- •a) within 90 days prior to Randomization, or b) anticipated during the fixed duration part of the double-blind [DB] period
- •- Hypotension, that is, systolic blood pressure (SBP) less than (<) 90 millimeters of mercury (mmHg) or diastolic blood pressure (DBP) <50 mmHg at Screening.
- •- Severe renal dysfunction with an estimated Glomerular Filtration Rate <30 milliliters per minute per 1.73 meter square (mL/min/1.73 m^2) using the Chronic Kidney Disease Epidemiology Collaboration formula at Screening
- •- Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based on records that confirm documented medical history
- •- Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)greater than or equal to (>=) 1.5*upper limit of normal (ULN) at Screening
- •- Hemoglobin <100 g/L (<10 gram per deciliter [g/dL]) at Screening
研究者
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