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OPsumit USers Registry

NCT ID: NCT02126943

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2686 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2020-04-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Opsumit (macitentan)

10 mg tablets

Opsumit (macitentan)

Intervention Type DRUG

10 mg tablets

Interventions

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Opsumit (macitentan)

10 mg tablets

Intervention Type DRUG

Other Intervention Names

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ACT-064992

Eligibility Criteria

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Inclusion Criteria

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

Signed ICF

Exclusion Criteria

Previous user of Opsumit defined as patient who initiated therapy \>30 days prior to enrollment.

Patients enrolled in any ongoing clinical trials
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Actelion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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V McLaughlin, MD

Role: STUDY_CHAIR

Chair of the OPUS scientific committee (OSC)

Locations

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Investigator Site

Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Fullerton, California, United States

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La Jolla, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Moreno Valley, California, United States

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San Juan Capistrano, California, United States

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Santa Barbara, California, United States

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Stanford, California, United States

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Aurora, Colorado, United States

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Denver, Colorado, United States

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Greeley, Colorado, United States

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Wheat Ridge, Colorado, United States

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New Haven, Connecticut, United States

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Newark, Delaware, United States

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

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Brandon, Florida, United States

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Celebration, Florida, United States

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Clermont, Florida, United States

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Fort Lauderdale, Florida, United States

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Gainesville, Florida, United States

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Hudson, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Leesburg, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Orlando, Florida, United States

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Pensacola, Florida, United States

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Sebring, Florida, United States

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South Miami, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Weston, Florida, United States

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Zephyrhills, Florida, United States

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Marietta, Georgia, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Oak Brook, Illinois, United States

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Oak Brook, Illinois, United States

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Carmel, Indiana, United States

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Fort Wayne, Indiana, United States

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Greenwood, Indiana, United States

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Indianapolis, Indiana, United States

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Clive, Iowa, United States

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Iowa City, Iowa, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Shreveport, Louisiana, United States

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South Portland, Maine, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Lansing, Michigan, United States

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Troy, Michigan, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Reno, Nevada, United States

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Cherry Hill, New Jersey, United States

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Newark, New Jersey, United States

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Union, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Fayetteville, New York, United States

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Hauppauge, New York, United States

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Mineola, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Greensboro, North Carolina, United States

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Pinehurst, North Carolina, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Lima, Ohio, United States

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Middleburg Heights, Ohio, United States

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Toledo, Ohio, United States

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Wooster, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Abington, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wynnewood, Pennsylvania, United States

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York, Pennsylvania, United States

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Anderson, South Carolina, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Rock Hill, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Chattanooga, Tennessee, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Sherman, Texas, United States

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Temple, Texas, United States

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Weslaco, Texas, United States

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Charlottesville, Virginia, United States

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Falls Church, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Ponce, PR, Puerto Rico

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Guaynabo, , Puerto Rico

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Countries

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United States Puerto Rico

References

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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.

Reference Type DERIVED
PMID: 39585521 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38451426 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38184507 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40388087 (View on PubMed)

Other Identifiers

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AC-055-503

Identifier Type: -

Identifier Source: org_study_id

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