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Pulmonary Arterial HypertensionOPUSNCT02126943

OPsumit USers Registry

An observational study of Pulmonary Arterial Hypertension, run by Actelion at 146 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Opsumit (macitentan)
Type of treatment
Pill or oral medicine
How many people
2,686 participants
Where
146 sitesin 2 countries
Study dates
30 Apr 2014to 24 Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients newly treated with Opsumit

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

146 sites in 2 countries.

146 sites in 2 countries

United States144 sites

  • Investigator Site

    Abington, Pennsylvania, 19001

  • Investigator Site

    Albany, New York, 12208

  • Investigator Site

    Albuquerque, New Mexico, 87106

  • Investigator Site

    Anderson, South Carolina, 29621

  • Investigator Site

    Ann Arbor, Michigan, 48109-0273

  • Investigator Site

    Aurora, Colorado, 80045

  • Investigator Site

    Baltimore, Maryland, 21201

  • Investigator Site

    Boston, Massachusetts, 02111

  • Investigator Site

    Boston, Massachusetts, 02114

  • Investigator Site

    Boston, Massachusetts, 02118

  • Investigator Site

    Brandon, Florida, 33511

  • Investigator Site

    Brooklyn, New York, 11215

  • Investigator Site

    Canton, Ohio, 44708

  • Investigator Site

    Carmel, Indiana, 46032

  • Investigator Site

    Celebration, Florida, 34747

  • Investigator Site

    Chapel Hill, North Carolina, 27599

  • Investigator Site

    Charleston, South Carolina, 29425

  • Investigator Site

    Charlottesville, Virginia, 22908

  • Investigator Site

    Chattanooga, Tennessee, 37404

  • Investigator Site

    Cherry Hill, New Jersey, 08034

  • Investigator Site

    Chicago, Illinois, 60611

  • Investigator Site

    Cincinnati, Ohio, 43130

  • Investigator Site

    Cincinnati, Ohio, 45219

  • Investigator Site

    Cincinnati, Ohio, 45242-5223

  • Investigator Site

    Cincinnati, Ohio, 45267-2564

  • Investigator Site

    Clermont, Florida, 34711

  • Investigator Site

    Clive, Iowa, 50325

  • Investigator Site

    Columbia, South Carolina, 29204

  • Investigator Site

    Columbus, Ohio, 43210

  • Investigator Site

    Columbus, Ohio, 43213

  • Investigator Site

    Dallas, Texas, 75390-8550

  • Investigator Site

    Dayton, Ohio, 45459

  • Investigator Site

    Denver, Colorado, 80206

  • Investigator Site

    Detroit, Michigan, 48202

  • Investigator Site

    Doylestown, Pennsylvania, 18907

  • Investigator Site

    Durham, North Carolina, 27710

  • Investigator Site

    Falls Church, Virginia, 22042

  • Investigator Site

    Fayetteville, New York, 13066

  • Investigator Site

    Fort Lauderdale, Florida, 33316

  • Investigator Site

    Fort Wayne, Indiana, 46804

  • Investigator Site

    Fullerton, California, 92835

  • Investigator Site

    Gainesville, Florida, 32610

  • Investigator Site

    Greeley, Colorado, 80631

  • Investigator Site

    Greensboro, North Carolina, 27401

  • Investigator Site

    Greenwood, Indiana, 46143

  • Investigator Site

    Hauppauge, New York, 11788

  • Investigator Site

    Honolulu, Hawaii, 96813

  • Investigator Site

    Houston, Texas, 77030

  • Investigator Site

    Hudson, Florida, 34667

  • Investigator Site

    Indianapolis, Indiana, 46260

  • Investigator Site

    Iowa City, Iowa, 52242

  • Investigator Site

    Jacksonville, Florida, 32207

  • Investigator Site

    Jacksonville, Florida, 32209

  • Investigator Site

    Kansas City, Kansas, 66160

  • Investigator Site

    Kissimmee, Florida, 34741

  • Investigator Site

    La Jolla, California, 92093

  • Investigator Site

    Lansing, Michigan, 48910

  • Investigator Site

    Leesburg, Florida, 34748

  • Investigator Site

    Lexington, Kentucky, 40536

  • Investigator Site

    Lima, Ohio, 45801

  • Investigator Site

    Lincoln, Nebraska, 68506

  • Investigator Site

    Loma Linda, California, 92354

  • Investigator Site

    Los Angeles, California, 90033

  • Investigator Site

    Los Angeles, California, 90095-1690

  • Investigator Site

    Los Angeles, California, 90211

  • Investigator Site

    Louisville, Kentucky, 40202

  • Investigator Site

    Madison, Wisconsin, 53792

  • Investigator Site

    Marietta, Georgia, 30060

  • Investigator Site

    Melbourne, Florida, 32901

  • Investigator Site

    Memphis, Tennessee, 38157

  • Investigator Site

    Miami, Florida, 33125

  • Investigator Site

    Miami, Florida, 33136

  • Investigator Site

    Miami Beach, Florida, 33140

  • Investigator Site

    Middleburg Heights, Ohio, 44130

  • Investigator Site

    Milwaukee, Wisconsin, 53215

  • Investigator Site

    Milwaukee, Wisconsin, 53226

  • Investigator Site

    Mineola, New York, 11501

  • Investigator Site

    Minneapolis, Minnesota, 55407-3799

  • Investigator Site

    Mobile, Alabama, 36604

  • Investigator Site

    Moreno Valley, California, 92553

  • Investigator Site

    New Haven, Connecticut, 06515

  • Investigator Site

    New Hyde Park, New York, 11040

  • Investigator Site

    New Orleans, Louisiana, 70112

  • Investigator Site

    New Orleans, Louisiana, 70121

  • Investigator Site

    New York, New York, 10016

  • Investigator Site

    New York, New York, 10029

  • Investigator Site

    Newark, Delaware, 19718

  • Investigator Site

    Newark, New Jersey, 07112

  • Investigator Site

    Norfolk, Virginia, 23507

  • Investigator Site

    Oak Brook, Illinois, 60181

  • Investigator Site

    Oak Brook, Illinois, 60523

  • Investigator Site

    Oklahoma City, Oklahoma, 73112

  • Investigator Site

    Omaha, Nebraska, 68198-5990

  • Investigator Site

    Orlando, Florida, 32803

  • Investigator Site

    Pensacola, Florida, 32504

  • Investigator Site

    Philadelphia, Pennsylvania, 19104

  • Investigator Site

    Philadelphia, Pennsylvania, 19107

  • Investigator Site

    Philadelphia, Pennsylvania, 19140

  • Investigator Site

    Phoenix, Arizona, 85006

  • Investigator Site

    Phoenix, Arizona, 85032

  • Investigator Site

    Phoenix, Arizona, 85054

  • Investigator Site

    Pinehurst, North Carolina, 28374

  • Investigator Site

    Pittsburgh, Pennsylvania, 15213

  • Investigator Site

    Plano, Texas, 75093

  • Investigator Site

    Portland, Oregon, 97210

  • Investigator Site

    Portland, Oregon, 97225

  • Investigator Site

    Portland, Oregon, 97239-3098

  • Investigator Site

    Reno, Nevada, 89503

  • Investigator Site

    Richmond, Virginia, 23298-0050

  • Investigator Site

    Rochester, Minnesota, 55905

  • Investigator Site

    Rock Hill, South Carolina, 29732

  • Investigator Site

    San Antonio, Texas, 78229

  • Investigator Site

    San Juan Capistrano, California, 92675

  • Investigator Site

    Santa Barbara, California, 93105

  • Investigator Site

    Seattle, Washington, 98195

  • Investigator Site

    Sebring, Florida, 33870

  • Investigator Site

    Sherman, Texas, 75092

  • Investigator Site

    Shreveport, Louisiana, 71105

  • Investigator Site

    Shreveport, Louisiana, 71130

  • Investigator Site

    Sioux Falls, South Dakota, 57108

  • Investigator Site

    South Miami, Florida, 33143

  • Investigator Site

    South Portland, Maine, 04106

  • Investigator Site

    Spokane, Washington, 99204

  • Investigator Site

    St Louis, Missouri, 63104

  • Investigator Site

    St Louis, Missouri, 63141

  • Investigator Site

    St. Petersburg, Florida, 33701

  • Investigator Site

    St. Petersburg, Florida, 33704

  • Investigator Site

    St. Petersburg, Florida, 33707

  • Investigator Site

    Stanford, California, 94305

  • Investigator Site

    Tacoma, Washington, 98405

  • Investigator Site

    Tampa, Florida, 33606

  • Investigator Site

    Temple, Texas, 76508-0001

  • Investigator Site

    The Bronx, New York, 10467

  • Investigator Site

    Toledo, Ohio, 43614

  • Investigator Site

    Troy, Michigan, 48085

  • Investigator Site

    Union, New Jersey, 07002

  • Investigator Site

    Washington D.C., District of Columbia, 20007

  • Investigator Site

    Weslaco, Texas, 78596

  • Investigator Site

    Weston, Florida, 33331

  • Investigator Site

    Wheat Ridge, Colorado, 80033

  • Investigator Site

    Wooster, Ohio, 44691

  • Investigator Site

    Wynnewood, Pennsylvania, 19096

  • Investigator Site

    York, Pennsylvania, 17402

  • Investigator Site

    Zephyrhills, Florida, 33542

Other trials in United States

Puerto Rico2 sites

  • Investigator Site

    Guaynabo, 00968

  • Investigator Site

    Ponce, PR, 00716

Other trials in Puerto Rico

About this study

Official title: US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice

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.

Being tested
Opsumit (macitentan)
Keywords
PAH, pulmonary arterial hypertension
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Opsumit (macitentan)Drug

    Also called ACT-064992

    10 mg tablets

Study groups in NCT02126943
Study groupRoleWhat they receive
Opsumit (macitentan)10 mg tablets
Receives: Drug: Opsumit (macitentan)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (1)

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2014 (estimated)
  2. Study start30 Apr 2014
  3. Primary completion24 Apr 2020
  4. Study completion24 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,686 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02126943
Sponsor's protocol ID
AC-055-503
Acronym
OPUS
Status last verified
Mar 2025
First submitted
29 Apr 2014
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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. 2026 Jan;43(1):231-254. doi: 10.1007/s12325-025-03403-4. Epub 2025 Nov 19.

    PubMed 41258625

  • 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.

    PubMed 40388087

  • 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.

    PubMed 39585521

  • 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.

    PubMed 38451426

  • 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.

    PubMed 38184507

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Arterial Hypertension, run by Actelion at 146 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To estimate incidence rates for specified outcomes. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02126943, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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