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Completed Phase 3 Interventional

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

ClinicalTrials.gov ID: NCT03626688

Public ClinicalTrials.gov record NCT03626688. 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.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 3:02 PM EDT

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, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAH

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03626688
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
United Therapeutics
Industry
Enrollment
687 participants

Conditions and interventions

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
Jan 24, 2019 (Actual)
Primary completion
Dec 31, 2025 (Actual)
Completion
Dec 31, 2025 (Actual)
Last update posted
Jun 16, 2026

2019 – 2025

United States locations

U.S. sites
68
U.S. states
29
U.S. cities
53
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 —
St. Joseph's Hospital and Medical Center Phoenix Arizona 85013 —
University of Arizona Tucson Arizona 85724 —
UCSD Health Sciences La Jolla California 92037 —
Loma Linda University Medical Center Loma Linda California 92354 —
Ronald Reagan UCLA Medical Center Los Angeles California 90024 —
Kaiser Permanente Los Angeles Medical Center Los Angeles California 90027 —
Keck Hospital of USC Los Angeles California 90033 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
VA Greater Los Angeles Healthcare System Los Angeles California 90073 —
University of California, Irvine Orange California 19103 —
University of California Davis Medical Center Sacramento California 95817 —
SBPA Research LLC Santa Barbara California 93105 —
Stanford Healthcare Stanford California 94305 —
LA Biomedical Research Institute Harbor-UCLA Medical Center Torrance California 90502 —
University of Colorado Hospital Aurora Colorado 80045 —
National Jewish Health Denver Colorado 80206 —
University of Florida Gainesville Florida 32610 —
University of Miami Miami Florida 33136 —
Central Florida Pulmonary Group Orlando Florida 32803 —
Cleveland Clinic Florida Weston Florida 33331 —
Emory University Hospital Atlanta Georgia 30322 —
Piedmont Healthcare Pulmonary and Critical Care Research Austell Georgia 30106 —
University of Chicago Medical Center Chicago Illinois 60637 —
Ascension Alexian Brothers Elk Grove Village Illinois 60007 —
Indiana University School of Medicine Indianapolis Indiana 46202 —
Community Health Network Cancer Center North Indianapolis Indiana 46250 —
St. Vincent Medical Group, Inc. Indianapolis Indiana 46260 —
University of Iowa Hospitals and Clinics Iowa City Iowa 52242 —
Kentuckiana Pulmonary Research Center Louisville Kentucky 40202 —
Ochsner Medical Center New Orleans Louisiana 70121 —
Chest Medicine Associates South Portland Maine 04106 —
University of Maryland Medical Center Baltimore Maryland 21201 —
Tufts Medical Center Boston Massachusetts 02111 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Boston University Medical Center Boston Massachusetts 02118 —
Spectrum Health Medical Group Grand Rapids Michigan 49546 —
Washington University School of Medicine St Louis Missouri 63110 —
Nebraska Medical Center Omaha Nebraska 68198 —
University of New Mexico Albuquerque New Mexico 87131 —
Winthrop Hospital Mineola New York 11501 —
NYU Langone Medical Center New York New York 10016 —
Weill-Cornell-New York Presbyterian Hospital New York New York 10021 —
Mount Sinai School of Medicine New York New York 10029 —
University of Rochester Rochester New York 14642 —
Duke University Medical Center Durham North Carolina 27710 —
East Carolina University Greenville North Carolina 27834 —
University of Cincinnati-Medical Science Building Cincinnati Ohio 45267 —
Cleveland Clinic Cleveland Ohio 44195 —
The Ohio State University Wexner Medical Center Columbus Ohio 43210 —
Integris Baptist Medical Center Oklahoma City Oklahoma 73112 —
Oregon Clinic-Pulmonary West Portland Oregon 97225 —
Oregon Health & Science University Portland Oregon 97239 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Thomas Jefferson University Hospital Philadelphia Pennsylvania 19107 —
Temple University Philadelphia Pennsylvania 19140 —
Allegheny General Hospital Pittsburgh Pennsylvania 15212 —
Statcare Pulmonary Consultants Knoxville Tennessee 37919 —
Ascension Texas Cardiovascular Austin Texas 78705 —
Baylor University Medical Center Dallas Texas 75246 —
UT Southwestern Medical Center Dallas Texas 75390 —
Memorial Hermann Hospital Houston Texas 77030 —
The Methodist Hospital Research Institute Houston Texas 77030 —
Vermont Lung Center Colchester Vermont 05446 —
University of Virginia Medical Center Charlottesville Virginia 22908 —
Sentara Cardiovascular Research Institute Norfolk Virginia 23507 —
Carilion Clinic Pulmonary and Sleep Medicine Roanoke Virginia 24014 —
Medical College of Wisconsin/Froedtert Hospital 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 141 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03626688, 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 Jun 16, 2026 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03626688 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →