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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: Active Phase 3 study of Pulmonary Arterial Hypertension, sponsored by Actelion.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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, o
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 |
What the registry record for NCT04273945 still lists
NCT04273945 is an interventional study that assigns participants to a tested intervention. The registered 935 participants enrollment target is mid-sized for trials with a published cap, above the 448-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (109% higher).
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 names 20 study sites across 12 states, led by 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.
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Where NCT04273945's enrollment target sits among peer trials
935 7th of 63 higher than 57 of 63 other Pulmonary Arterial Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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