Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04273945 · ClinicalTrials.gov registry record · Phase 3
Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
A Phase 3 study of Pulmonary Arterial Hypertension, sponsored by Actelion.
- Active
- Registry status
- Phase 3
- Development phase
- 935
- Enrollment target
- 20
- Study locations
NCT04273945 is a Phase 3 study of Pulmonary Arterial Hypertension that is active but no longer recruiting, run by Actelion. The registered enrollment target is 935 participants, above the 448-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (109% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT04273945, a Phase 3 study of Pulmonary Arterial Hypertension, is active but no longer recruiting, sponsored by Actelion.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 935 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Macitentan 10 mg
- DRUG Macitentan 37.5 mg
- DRUG Macitentan 75 mg
Study Locations (20)
California
- Scripps Memorial Hospital - La Jolla
- USC Keck - Los Angeles
- Jeffrey S. Sager, MD Medical Corporation - Santa Barbara
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
Arizona
- Mayo Clinic - Phoenix
- Arizona Pulmonary Specialists, Ltd - Scottsdale
Georgia
- Piedmont Healthcare - Atlanta
- Northside Hospital - Atlanta
Indiana
- Indiana University - Indianapolis
- St. Vincent Medical Group, Inc. - Indianapolis
Michigan
- University of Michigan - Ann Arbor
- Troy Beaumont - Troy
Missouri
- Washington University School Of Medicine - St Louis
- Saint Louis University Academic Pavillion - St Louis
Colorado
- National Jewish Health - Denver
Florida
- Cleveland Clinic - Weston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 935 participants |
| Start Date | 2020-06-30 |
| Est. Completion | 2029-02-20 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04273945
The ClinicalTrials.gov registry entry for NCT04273945 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 935 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 448-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (109% higher). The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04273945 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Arizona, Georgia.
Frequently Asked Questions
What is clinical trial NCT04273945 about?
NCT04273945 is a clinical study titled "Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension". 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...
What is the current status of trial NCT04273945?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 935 participants. The study started on 2020-06-30. Estimated completion is 2029-02-20.
What conditions does trial NCT04273945 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT04273945?
The interventions under investigation include: Placebo (DRUG), Macitentan 10 mg (DRUG), Macitentan 37.5 mg (DRUG), Macitentan 75 mg (DRUG).
Who is sponsoring clinical trial NCT04273945?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04273945 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Arterial Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH
RECRUITING · Phase 3
-
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
RECRUITING · Phase 3
-
Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
ACTIVE NOT RECRUITING · Phase 3
-
A Phase 3 Study to Evaluate the Safety and Tolerability of L606 in Subjects With PAH or PH-ILD
ACTIVE NOT RECRUITING · Phase 3
-
The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension
COMPLETED · Phase 3
-
Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.