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Clinical Trials in the USA / NCT04273945
Active, not recruiting Phase 3

Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension

NCT04273945 · tracked via the Priya Life Science USA tracker
Sponsor
Actelion
Phase
Phase 3
Started
2020-06-30
Last updated
2026-08-28

Condition(s) studied

Pulmonary Arterial Hypertension

Investigational drug(s) / intervention(s)

Macitentan 10 mgMacitentan 37.5 mgMacitentan 75 mgPlacebo

Macitentan 10 mg: Participants will receive macitentan 10 mg film-coated tablets orally.

Macitentan 37.5 mg: Participants will receive macitentan 37.5 mg film-coated tablets orally.

Macitentan 75 mg: Participants will receive macitentan 75 mg film-coated tablets orally.

Placebo: Participants will receive matching placebo film-coated tablets orally.

Study summary

The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Target population: greater than or equal to (\>=) 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age * Target population: Symptomatic Pulmonary Arterial Hypertension (PAH) in World Health Organization Functional Class (WHO FC) II, III, or IV * Target population: PAH subtype falling in one of the below classifications: Idiopathic; Heritable; Drug- or toxin-induced; Related to: Connective tissue disease, HIV infection, Portal hypertension, and Congenital heart disease with small/coincidental cardiac defect with systemic-to-pulmonary shunt (for example atrial septal defect, ventricular septal defect, patent ductus arteriosus, atrioventricular septal defect) which does not account for the elevated pulmonary vascular resistance (PVR) or persistent PAH documented by an Right heart catheterization (RHC) \>= 1 year after simple systemic-to pulmonary shunt repair * PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to screening: Mean pulmonary artery pressure (mPAP) greater than (\>) 20 millimeters of mercury (mm Hg), and; Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) less than or equal to (\<=) 15 mm Hg, and PVR \>= 3 Wood Units (that is, \>= 240 dyn\*sec/cm\^5) * Able to perform the 6-minute walking test (6MWT) with a minimum distance of 50 meters (m) and maximum distance of 440m at screening. Participants able to walk more than 440m at screening are eligible if they are in WHO FC III or IV and n-terminal prohormone of brain natriuretic peptide or n-terminal pro B-type natriuretic peptide (NT-proBNP) level is \>=300 nanograms per liter (ng/L) at screening, based on central laboratory results Exclusion Criteria: * Known presence of three or more of the following risk factors for heart failure with preserved ejection fraction at screening, based on records that confirm documented medical history: Body mass index (BMI) \> 30 kilograms per meter square (kg/m\^2), Diabetes mellitus of any type, Essential hypertension (even if well controlled); Coronary artery disease, that is, any of the following: history of stable angina, or known more than 50 percent (%) stenosis in a coronary artery, or history of myocardial infarction, or history of or planned coronary artery bypass grafting and/or coronary artery stenting * Presence of moderate or severe obstructive lung disease (forced expiratory volume in 1 second \[FEV1\] / forced vital capacity \[FVC\] \< 70%; and FEV1 \< 60% of predicted after bronchodilator administration) ) in participants with a known or suspected history of significant lung disease as documented by a spirometry test performed within 1 year prior to 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) \> 1.5\*upper limit of normal (ULN) at screening * Hemoglobin \< 100 gram per liter (g/L) (\< 10 gram per deciliter \[g/dL\]) at screening

Primary outcome measure(s)

Trial sites (274)

FacilityCityRegionStatus
Mayo Clinic Phoenix Arizona
Arizona Pulmonary Specialists, Ltd Scottsdale Arizona
Scripps Memorial Hospital La Jolla California
USC Keck Los Angeles California
Jeffrey S. Sager, MD Medical Corporation Santa Barbara California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California
National Jewish Health Denver Colorado
Cleveland Clinic Weston Florida
Piedmont Healthcare Atlanta Georgia
Northside Hospital Atlanta Georgia
Advocate Christ Medical Center Oak Lawn Illinois
Indiana University Indianapolis Indiana
St. Vincent Medical Group, Inc. Indianapolis Indiana
University Of Iowa - Hospitals & Clinics Iowa City Iowa
Norton Pulmonary Specialists Louisville Kentucky
Louisiana State University New Orleans Louisiana
University of Michigan Ann Arbor Michigan
Troy Beaumont Troy Michigan
Washington University School Of Medicine St Louis Missouri
Saint Louis University Academic Pavillion St Louis Missouri
University of Nebraska Medical Center Omaha Nebraska
Reno Heart Institute Reno Nevada
Winthrop University Hospital Mineola New York
Mount Sinai New York New York
Columbia University New York New York
Stony Brook University Medical Center Stony Brook New York
Duke Durham North Carolina
Lindner Clinical Trial Center/Christ Hospital Cincinnati Ohio
Integris Baptist Office Oklahoma City Oklahoma
The Oregon Clinic Pulmonary West Beaverton Oregon
The Oregon Clinic Portland Oregon
Oregon Health And Science University Portland Oregon
University of Pennsylvania Philadelphia Pennsylvania
Allegheny General Hospital of Research Pittsburgh Pennsylvania
Lankenau Medical Center Wynnewood Pennsylvania
AnMed Health Anderson South Carolina
UT Southwestern Medical Center Dallas Texas
Baylor College of Medicine (BCM) - Baylor Heart Clinic Houston Texas
Baylor Scott White - Plano Plano Texas
San Antonio Methodist TX Transplant Physicians Group San Antonio Texas

+ 234 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04273945 on ClinicalTrials.gov ↗ ← All trials in the USA