OPsumit USers Registry

NCT02126943 | Completed

• 1 other identifier: AC-055-503
• Study Type: observational
• Target: 2,686
• Locations: 2 countries
• Sites: 146

Brief Summary

Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.

Conditions

Pulmonary Arterial Hypertension

Keywords

PAH; pulmonary arterial hypertension

Outcome Measures

Primary Outcomes (1)

• To estimate incidence rates for specified outcomes.

  Liver test abnormalities/ Occurrence of Hepatic Adverse Events (HAEs)/ Occurrence of any other AEs/ Discontinuation of Opsumit and reason for stopping therapy/ Hospitalization and death.

  1 year

Secondary Outcomes (1)

• To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period.

  1 year

Other Outcomes (1)

• To describe PAH treatment patterns at enrollment and during observation period.

  1 year

Study Arms (1)

Opsumit (macitentan)

10 mg tablets

Drug: Opsumit (macitentan)

Interventions

Opsumit (macitentan) DRUG

10 mg tablets

Also known as: ACT-064992

Opsumit (macitentan)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients newly treated with Opsumit

You may qualify if:

• Patients newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit.
• Signed ICF

You may not qualify if:

• Previous user of Opsumit defined as patient who initiated therapy \>30 days prior to enrollment.
• Patients enrolled in any ongoing clinical trials

Sponsors & Collaborators

• Actelion: lead

Study Sites (146)

Investigator Site

Mobile, Alabama, 36604, United States

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Phoenix, Arizona, 85006, United States

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Phoenix, Arizona, 85032, United States

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Phoenix, Arizona, 85054, United States

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Fullerton, California, 92835, United States

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La Jolla, California, 92093, United States

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Loma Linda, California, 92354, United States

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Los Angeles, California, 90033, United States

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Los Angeles, California, 90095-1690, United States

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Los Angeles, California, 90211, United States

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Moreno Valley, California, 92553, United States

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San Juan Capistrano, California, 92675, United States

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Santa Barbara, California, 93105, United States

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Stanford, California, 94305, United States

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Aurora, Colorado, 80045, United States

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Denver, Colorado, 80206, United States

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Greeley, Colorado, 80631, United States

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Wheat Ridge, Colorado, 80033, United States

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New Haven, Connecticut, 06515, United States

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Newark, Delaware, 19718, United States

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Washington D.C., District of Columbia, 20007, United States

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Brandon, Florida, 33511, United States

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Celebration, Florida, 34747, United States

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Clermont, Florida, 34711, United States

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Fort Lauderdale, Florida, 33316, United States

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Gainesville, Florida, 32610, United States

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Hudson, Florida, 34667, United States

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Jacksonville, Florida, 32207, United States

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Jacksonville, Florida, 32209, United States

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Kissimmee, Florida, 34741, United States

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Leesburg, Florida, 34748, United States

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Melbourne, Florida, 32901, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33136, United States

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Miami Beach, Florida, 33140, United States

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Orlando, Florida, 32803, United States

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Pensacola, Florida, 32504, United States

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Sebring, Florida, 33870, United States

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South Miami, Florida, 33143, United States

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St. Petersburg, Florida, 33701, United States

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St. Petersburg, Florida, 33704, United States

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St. Petersburg, Florida, 33707, United States

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Tampa, Florida, 33606, United States

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Weston, Florida, 33331, United States

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Zephyrhills, Florida, 33542, United States

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Marietta, Georgia, 30060, United States

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Honolulu, Hawaii, 96813, United States

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Chicago, Illinois, 60611, United States

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Oak Brook, Illinois, 60181, United States

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Oak Brook, Illinois, 60523, United States

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Carmel, Indiana, 46032, United States

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Fort Wayne, Indiana, 46804, United States

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Greenwood, Indiana, 46143, United States

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Indianapolis, Indiana, 46260, United States

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Clive, Iowa, 50325, United States

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Iowa City, Iowa, 52242, United States

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Kansas City, Kansas, 66160, United States

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Lexington, Kentucky, 40536, United States

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Louisville, Kentucky, 40202, United States

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New Orleans, Louisiana, 70112, United States

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New Orleans, Louisiana, 70121, United States

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Shreveport, Louisiana, 71105, United States

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Shreveport, Louisiana, 71130, United States

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South Portland, Maine, 04106, United States

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Baltimore, Maryland, 21201, United States

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Boston, Massachusetts, 02111, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02118, United States

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Ann Arbor, Michigan, 48109-0273, United States

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Detroit, Michigan, 48202, United States

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Lansing, Michigan, 48910, United States

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Troy, Michigan, 48085, United States

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Minneapolis, Minnesota, 55407-3799, United States

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Rochester, Minnesota, 55905, United States

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St Louis, Missouri, 63104, United States

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St Louis, Missouri, 63141, United States

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Lincoln, Nebraska, 68506, United States

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Omaha, Nebraska, 68198-5990, United States

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Reno, Nevada, 89503, United States

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Cherry Hill, New Jersey, 08034, United States

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Newark, New Jersey, 07112, United States

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Union, New Jersey, 07002, United States

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Albuquerque, New Mexico, 87106, United States

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Albany, New York, 12208, United States

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Brooklyn, New York, 11215, United States

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Fayetteville, New York, 13066, United States

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Hauppauge, New York, 11788, United States

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Mineola, New York, 11501, United States

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New Hyde Park, New York, 11040, United States

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New York, New York, 10016, United States

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New York, New York, 10029, United States

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The Bronx, New York, 10467, United States

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Chapel Hill, North Carolina, 27599, United States

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Durham, North Carolina, 27710, United States

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Greensboro, North Carolina, 27401, United States

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Pinehurst, North Carolina, 28374, United States

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Canton, Ohio, 44708, United States

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Cincinnati, Ohio, 43130, United States

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Cincinnati, Ohio, 45219, United States

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Cincinnati, Ohio, 45242-5223, United States

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Cincinnati, Ohio, 45267-2564, United States

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Columbus, Ohio, 43210, United States

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Columbus, Ohio, 43213, United States

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Dayton, Ohio, 45459, United States

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Lima, Ohio, 45801, United States

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Middleburg Heights, Ohio, 44130, United States

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Toledo, Ohio, 43614, United States

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Wooster, Ohio, 44691, United States

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Oklahoma City, Oklahoma, 73112, United States

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Portland, Oregon, 97210, United States

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Portland, Oregon, 97225, United States

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Portland, Oregon, 97239-3098, United States

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Abington, Pennsylvania, 19001, United States

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Doylestown, Pennsylvania, 18907, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107, United States

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Philadelphia, Pennsylvania, 19140, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Wynnewood, Pennsylvania, 19096, United States

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York, Pennsylvania, 17402, United States

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Anderson, South Carolina, 29621, United States

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Charleston, South Carolina, 29425, United States

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Columbia, South Carolina, 29204, United States

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Rock Hill, South Carolina, 29732, United States

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Sioux Falls, South Dakota, 57108, United States

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Chattanooga, Tennessee, 37404, United States

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Memphis, Tennessee, 38157, United States

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Dallas, Texas, 75390-8550, United States

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Houston, Texas, 77030, United States

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Plano, Texas, 75093, United States

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San Antonio, Texas, 78229, United States

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Sherman, Texas, 75092, United States

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Temple, Texas, 76508-0001, United States

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Weslaco, Texas, 78596, United States

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Charlottesville, Virginia, 22908, United States

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Falls Church, Virginia, 22042, United States

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Norfolk, Virginia, 23507, United States

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Richmond, Virginia, 23298-0050, United States

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Seattle, Washington, 98195, United States

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Spokane, Washington, 99204, United States

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Tacoma, Washington, 98405, United States

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Madison, Wisconsin, 53792, United States

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Milwaukee, Wisconsin, 53215, United States

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Milwaukee, Wisconsin, 53226, United States

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Ponce, PR, 00716, Puerto Rico

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Guaynabo, 00968, Puerto Rico

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Related Publications (5)

• Melendres-Groves LD, Channick RN, Chin KM, McLaughlin VV, MacDonald G, Martin N, Ong R, Sandros M, Kim NH. Characteristics, Treatment Patterns and Outcomes of Patients with Pulmonary Arterial Hypertension by Race and Ethnicity Using Real-World Data from the Combined OPUS/OrPHeUS Studies. Adv Ther. 2025 Nov 19. doi: 10.1007/s12325-025-03403-4. Online ahead of print.

  PMID: 41258625 DERIVED

• Kim NH, Chin KM, McLaughlin VV, Ong R, MacDonald G, Martin N, Senatore A, Channick R. Macitentan and Tadalafil Combination Therapy in Patients with Pulmonary Arterial Hypertension and Cardiovascular Comorbidities: Real-World Evidence from OPUS and OrPHeUS. Adv Ther. 2025 Jul;42(7):3306-3333. doi: 10.1007/s12325-025-03180-0. Epub 2025 May 19.

  PMID: 40388087 DERIVED

• Chin KM, Channick R, Kim NH, Ong R, Turricchia S, Martin N, Mitchell L, McLaughlin VV. Macitentan in Pulmonary Arterial Hypertension Due to Congenital Heart Disease (CHD-PAH): Real-World Evidence from the OPUS/OrPHeUS Studies. Cardiol Ther. 2024 Dec;13(4):775-796. doi: 10.1007/s40119-024-00386-1. Epub 2024 Nov 25.

  PMID: 39585521 DERIVED

• Channick R, Chin KM, McLaughlin VV, Lammi MR, Zamanian RT, Turricchia S, Ong R, Mitchell L, Kim NH. Macitentan in Pulmonary Arterial Hypertension Associated with Connective Tissue Disease (CTD-PAH): Real-World Evidence from the Combined OPUS/OrPHeUS Dataset. Cardiol Ther. 2024 Jun;13(2):315-339. doi: 10.1007/s40119-024-00361-w. Epub 2024 Mar 7.

  PMID: 38451426 DERIVED

• Kim NH, Chin KM, McLaughlin VV, DuBrock H, Restrepo-Jaramillo R, Safdar Z, MacDonald G, Martin N, Rosenberg D, Solonets M, Channick R. Safety of Macitentan for the Treatment of Portopulmonary Hypertension: Real-World Evidence from the Combined OPUS/OrPHeUS Studies. Pulm Ther. 2024 Mar;10(1):85-107. doi: 10.1007/s41030-023-00251-x. Epub 2024 Jan 7.

  PMID: 38184507 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

macitentan

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• V McLaughlin, MD

  Chair of the OPUS scientific committee (OSC)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: April 30, 2014
• Study Start: April 30, 2014
• Primary Completion: April 24, 2020
• Study Completion: April 24, 2020
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

US (144); PR (2)