Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
Public ClinicalTrials.gov record NCT04273945. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04273945
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 935 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2020 (Actual)
- Primary completion
- Oct 7, 2025 (Actual)
- Completion
- Feb 20, 2029 (Estimated)
- Last update posted
- Oct 6, 2026
2020 – 2029
United States locations
- U.S. sites
- 43
- U.S. states
- 24
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | — |
| Arizona Pulmonary Specialists, Ltd | Scottsdale | Arizona | 85258 | — |
| Scripps Memorial Hospital | La Jolla | California | 92037 | — |
| USC Keck | Los Angeles | California | 90033 | — |
| Jeffrey S. Sager, MD Medical Corporation | Santa Barbara | California | 93105 | — |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | 90502-2006 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| Cleveland Clinic | Weston | Florida | 33331 3609 | — |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | — |
| Northside Hospital | Atlanta | Georgia | 30342 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| St. Vincent Medical Group, Inc. | Indianapolis | Indiana | 46260 | — |
| University Of Iowa - Hospitals & Clinics | Iowa City | Iowa | 52242 | — |
| Norton Pulmonary Specialists | Louisville | Kentucky | 40202 | — |
| Louisiana State University | New Orleans | Louisiana | 70112 7021 | — |
| University of Michigan | Ann Arbor | Michigan | 48109-5000 | — |
| Troy Beaumont | Troy | Michigan | 53215 | — |
| Washington University School Of Medicine | St Louis | Missouri | 63110-1032 | — |
| Saint Louis University Academic Pavillion | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-2265 | — |
| Reno Heart Institute | Reno | Nevada | 89511 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| Mount Sinai | New York | New York | 10029 | — |
| Columbia University | New York | New York | 10032 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| Duke | Durham | North Carolina | 27710-4000 | — |
| Lindner Clinical Trial Center/Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Integris Baptist Office | Oklahoma City | Oklahoma | 73112 | — |
| The Oregon Clinic Pulmonary West | Beaverton | Oregon | 97008 | — |
| The Oregon Clinic | Portland | Oregon | 97220-9442 | — |
| Oregon Health And Science University | Portland | Oregon | 97239-3011 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104-5545 | — |
| Allegheny General Hospital of Research | Pittsburgh | Pennsylvania | 15212 | — |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | — |
| AnMed Health | Anderson | South Carolina | 29621 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Baylor College of Medicine (BCM) - Baylor Heart Clinic | Houston | Texas | 77030 | — |
| Baylor Scott White - Plano | Plano | Texas | 75093 | — |
| San Antonio Methodist TX Transplant Physicians Group | San Antonio | Texas | 78229-3771 | — |
| The Robert Larner, M.D. College of Medicine at The University of Vermont | Burlington | Vermont | 05405 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
| Medical College Of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 231 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04273945, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 6, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04273945 live on ClinicalTrials.gov.