A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Chronic Thromboembolic Pulmonary Hypertension

In brief

The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).

Key facts

Study ID

NCT04271475

Run by

Actelion

People needed

127

Starts

2020-07-07

Expected to finish

2023-12-21

Last updated by the study team

2025-06-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Keck School of Medicine of USC — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• University of Florida Health Jacksonville — Gainesville, Florida, United States
• Piedmont Healthcare — Atlanta, Georgia, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Maryland — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• VA Sierra Nevada Health Care System — Reno, Nevada, United States
• University of New Mexico School of Medicine — Albuquerque, New Mexico, United States
• Syracuse VA Medical Center — Syracuse, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Legacy Hospital — Portland, Oregon, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baylor Scott White - Plano — Plano, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• University of Utah Cardiovascular Center — Salt Lake City, Utah, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• Nexo Salud Investigacion Clinica — Buenos Aires, Argentina
• University of California San Diego Medical Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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