Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Double-blind Treatment Period: Time to First Clinical Events Committee (CEC)-adjudicated Morbidity or Mortality (M/M) Events — Up to 4 years
Time to first CEC-adjudicated M/M event on-treatment (ie.,up to 7 days after last dose of DB study intervention) is defined as time from randomization to first of following events: All-cause death, including death caused by on-treatment adverse event that occur within 4 weeks of study DB treatment discontinuation;non-planned Pulmonary Arterial Hypertension(PAH)-related hospitalization(including for worsening of PAH, atrial septostomy, lung transplantation with or without heart transplantation, or initiation of parenteral prostacyclins);PAH-related disease progression, defined as worsening of World Health Organization(WHO) Functional Class(FC) from baseline or deterioration by at least 15% in exercise capacity, as measured by 6-minute walk distance(6MWD), from baseline and confirmed by second 6MWD test performed on different day within 2 week of initial test or appearance or worsening of signs or symptoms of right-sided heart failure that require initiation of intravenous diuretics.
Trial sites (274)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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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 Australia