A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
Completed · Phase 3 · NCT03626688
Conditions: PAH, Pulmonary Hypertension, Pulmonary Arterial Hypertension, Hypertension, Connective Tissue Diseases, Familial Primary Pulmonary Hypertension, Vascular Diseases, Cardiovascular Diseases, Hypertension, Pulmonary, Lung Diseases, Respiratory Tract Disease
At a glance
- Research payments reported, 2025
- $1.8M
- U.S. investigators named
- 51
- Sites paid
- 50
- Planned or actual enrollment
- 687
About the trial
- Sponsor
- United Therapeutics
- Tested
- Ralinepag (drug), Placebo (drug)
- Dates
- Started 2019-01-24; completion 2025-12-31
- Results posted
- Not yet
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
From ClinicalTrials.gov, last updated 2026-06-16. Full record, eligibility and contacts (opens in a new tab)
Industry funding
United Therapeutics Corporation reported $1.8M in research payments for this study in 2025 (486 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Jose Tallaj Heart Failure & Transplant Cardiology · Birmingham, AL
- Bhuvin M. Buddhdev, MD Pulmonology · Phoenix, AZ
- Franz Rischard, DO Internal Medicine · Tucson, AZ
- Adam J. Brownstein, MD Pulmonology · Los Angeles, CA
- Timothy M. Fernandes, MD Pulmonology · La Jolla, CA
- Sivagini Ganesh, M.D. Pulmonology · Los Angeles, CA
- Paresh C. Giri, M.D. Pulmonology · Yucaipa, CA
- Jeffrey S. Sager, MD Pulmonology · Santa Barbara, CA
- Shelley M. Shapiro, MD Pulmonology · Los Angeles, CA
- Namita Sood, M.D. Pulmonology · Sacramento, CA
- Bassam Yaghmour, M.D. Critical Care Medicine · Orange, CA
- Roham T. Zamanian, MD Pulmonology · Stanford, CA
- David Badesch, MD Pulmonology · Aurora, CO
- Marjorie P. George, MD Pulmonology · Denver, CO
- Sashi Adigopula, M.D. Heart Failure & Transplant Cardiology · Fort Myers, FL
- Ali Ataya, M.D. Critical Care Medicine · Gainesville, FL
- Charles Burger, MD Pulmonology · Jacksonville, FL
- Daniel T. Layish, M.D. Pulmonology · Orlando, FL
- Stacy A. Mandras, MD Heart Failure & Transplant Cardiology · Orlando, FL
- Jinesh Mehta, M.D. Pulmonology · Weston, FL
- Micah R. Fisher, MD Pulmonology · Atlanta, GA
- Chad Miller, MD Pulmonology · Austell, GA
- Linda M. Cadaret, MD Heart Failure & Transplant Cardiology · Iowa City, IA
- Ashish Haryani, MD Heart Failure & Transplant Cardiology · Elk Grove Village, IL
- Stanley Swat Heart Failure & Transplant Cardiology · Chicago, IL
- Ashwin K. Ravichandran, MD Heart Failure & Transplant Cardiology · Indianapolis, IN
- Nicholas S. Hill, MD Pulmonology · Boston, MA
- Gautam V. Ramani, MD Heart Failure & Transplant Cardiology · Baltimore, MD
- Reda E. Girgis, MD Pulmonology · Grand Rapids, MI
- Murali M. Chakinala, MD Pulmonology · Saint Louis, MO
- Terry A. Fortin, MD Cardiology · Durham, NC
- Lana Melendres-groves, MD Pulmonology · Albuquerque, NM
- Daniel J. Lachant, D.O. Pulmonology · Rochester, NY
- Josanna M. Rodriguez-lopez, M.D. Pulmonology · New York, NY
- Roxana Sulica, M.D., Critical Care Medicine · New York, NY
- R J. White, MD Pulmonology · Rochester, NY
- Jean M. Elwing, MD Pulmonology · Cincinnati, OH
- Veronica Franco, MD Heart Failure & Transplant Cardiology · Columbus, OH
- Lianne L. Lin, MD Pulmonology · Beaverton, OR
- Jeffrey C. Robinson, M.D. Pulmonology · Portland, OR
- Jason S. Fritz, MD Critical Care Medicine · Philadelphia, PA
- Amresh Raina, MD Heart Failure & Transplant Cardiology · Pittsburgh, PA
- Michael Scharf, MD Pulmonology · Philadelphia, PA
- John W. Swisher, PHD, M.D. Pulmonology · Knoxville, TN
- Sonja D. Bartolome, M.D. Pulmonology · Dallas, TX
- Chetan A. Naik, M.D. Pulmonology · Dallas, TX
- Bela Patel, M.D. Pulmonology · Houston, TX
- Raju M. Reddy, M.D. Pulmonology · Austin, TX
- Zeenat Safdar, MD Pulmonology · Houston, TX
- Sameh Aziz, MD Critical Care Medicine · Roanoke, VA
- Kenneth Presberg, MD Pulmonology · Milwaukee, WI
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- University of Florida $174,004
- The Methodist Hospital Research Institute $125,733
- Strong Memorial Hospital, NY $122,063
- Ronald Reagan UCLA Medical Center, CA $87,827
- University of California Davis Medical Center, CA $84,661
- St Josephs Hospital and Medical Center, AZ $69,357
- University of Cincinnati Physicians Company, LLC $66,320
- The Board of Trustees of the Leland Stanford Junior University $62,482
- Corewell Health $61,414
- University of Southern California $58,706
- The Regents of the University of California $53,953
- The University of Texas Southwestern Medical Center $50,692
- NYU Grossman School of Medicine $47,580
- Ascension Seton Medical Center Austin, TX $43,022
- Uci Health-Orange, CA $42,619
- Baylor Research Institute $41,508
- Emory University Hospital, GA $37,564
- Medical College of Wisconsin Inc $34,529
- University of New Mexico Hsc $32,895
- The University of Maryland Baltimore $30,209
- Carilion Medical Center, VA $30,179
- Community Hospital East, IN $29,941
- National Jewish Health, CO $28,697
- The University of Arizona $28,620
- The University of Chicago $26,628
- Regents of the University of Colorado $25,904
- University of Iowa Hospital & Clinics, IA $24,417
- Cleveland Clinic Florida $23,403
- Jeffrey S. Sager, MD Medical Corporation $23,036
- Central Indiana Health Services Cardiac Services, Inc $22,736
- Thomas Jefferson University $22,579
- The Washington University $21,725
- Mayo Clinic Jacksonville $20,271
- Massachusetts General Hospital, MA $18,405
- $17,676
- Allegheny Singer Research Institute $17,342
- The University of Texas Health $17,017
- Alexian Brothers Health System $16,662
- University of Alabama Hospital, AL $16,625
- Ohsu Hospital and Clinics, OR $16,466
- Tufts Medical Center, MA $14,786
- Central Florida Pulmonary Group P A $14,428
- Duke University Department of Medicine $14,036
- Adventhealth Orlando, FL $6,025
- Center for Biomedical Research $5,270
- Hospital of Univ of Pennsylvania, PA $4,028
- The Ohio State University $3,922
- Greater Los Angeles Veterans Research and Education Foundation $2,195
- The Oregon Clinic PC $1,260
- Loma Linda University Health (lluh) $180
- Piedmont Healthcare, Inc. $52
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.