Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension (NCT04273945)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (274 Sites)
Showing the first 25 of 274 sites.
- 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
📞 Contact the Study Coordinator
Phone: (800) 664-4580
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Pulmonary Arterial Hypertension
- A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION) — Aurora, Colorado
- A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension — Phoenix, Arizona
- Pulmonary Vascular Disease Phenomics Program PVDOMICS — Tucson, Arizona
- An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH) — Jacksonville, Florida
- A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension — Aurora, Colorado
- ADAPT - A Patient Registry of the Real-world Use of Orenitram® — Fresno, California
Explore by condition: All Pulmonary Arterial Hypertension clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.