A study to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertensio
- Conditions
- Chronic thromboembolic pulmonary hypertension
- Registration Number
- JPRN-jRCT2051200150
- Lead Sponsor
- akano Masayoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 144
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 28 in 6- minute Walk Distance [6MWD]<br>Baseline up to Week 28<br>Change from baseline to week 28 in 6MWD as measured by 6-minute walk test [6MWT]) will be reported. The purpose of the six-minute walk test (6MWT) is to quantify exercise tolerance and capacity. This standardized test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in 6 minutes.
- Secondary Outcome Measures
Name Time Method