OPsumit USers Registry (OPUS)

March 28, 2025 updated by: Actelion

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2686

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968
        • Investigator Site
      • Ponce, Puerto Rico, 00716
        • Investigator Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Investigator Site
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Investigator Site
      • Phoenix, Arizona, United States, 85006
        • Investigator Site
      • Phoenix, Arizona, United States, 85054
        • Investigator Site
    • California
      • Fullerton, California, United States, 92835
        • Investigator Site
      • La Jolla, California, United States, 92093
        • Investigator Site
      • Loma Linda, California, United States, 92354
        • Investigator Site
      • Los Angeles, California, United States, 90033
        • Investigator Site
      • Los Angeles, California, United States, 90095-1690
        • Investigator Site
      • Los Angeles, California, United States, 90211
        • Investigator Site
      • Moreno Valley, California, United States, 92553
        • Investigator Site
      • San Juan Capistrano, California, United States, 92675
        • Investigator Site
      • Santa Barbara, California, United States, 93105
        • Investigator Site
      • Stanford, California, United States, 94305
        • Investigator Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Investigator Site
      • Denver, Colorado, United States, 80206
        • Investigator Site
      • Greeley, Colorado, United States, 80631
        • Investigator Site
      • Wheat Ridge, Colorado, United States, 80033
        • Investigator Site
    • Connecticut
      • New Haven, Connecticut, United States, 06515
        • Investigator Site
    • Delaware
      • Newark, Delaware, United States, 19718
        • Investigator Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Investigator Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Investigator Site
      • Celebration, Florida, United States, 34747
        • Investigator Site
      • Clermont, Florida, United States, 34711
        • Investigator Site
      • Fort Lauderdale, Florida, United States, 33316
        • Investigator Site
      • Gainesville, Florida, United States, 32610
        • Investigator Site
      • Hudson, Florida, United States, 34667
        • Investigator Site
      • Jacksonville, Florida, United States, 32207
        • Investigator Site
      • Jacksonville, Florida, United States, 32209
        • Investigator Site
      • Kissimmee, Florida, United States, 34741
        • Investigator Site
      • Leesburg, Florida, United States, 34748
        • Investigator Site
      • Melbourne, Florida, United States, 32901
        • Investigator Site
      • Miami, Florida, United States, 33136
        • Investigator Site
      • Miami, Florida, United States, 33125
        • Investigator Site
      • Miami Beach, Florida, United States, 33140
        • Investigator Site
      • Orlando, Florida, United States, 32803
        • Investigator Site
      • Pensacola, Florida, United States, 32504
        • Investigator Site
      • Saint Petersburg, Florida, United States, 33701
        • Investigator Site
      • Saint Petersburg, Florida, United States, 33704
        • Investigator Site
      • Saint Petersburg, Florida, United States, 33707
        • Investigator Site
      • Sebring, Florida, United States, 33870
        • Investigator Site
      • South Miami, Florida, United States, 33143
        • Investigator Site
      • Tampa, Florida, United States, 33606
        • Investigator Site
      • Weston, Florida, United States, 33331
        • Investigator Site
      • Zephyrhills, Florida, United States, 33542
        • Investigator Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Investigator Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Investigator Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Investigator Site
      • Oak Brook, Illinois, United States, 60181
        • Investigator Site
      • Oak Brook, Illinois, United States, 60523
        • Investigator Site
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Investigator Site
      • Fort Wayne, Indiana, United States, 46804
        • Investigator Site
      • Greenwood, Indiana, United States, 46143
        • Investigator Site
      • Indianapolis, Indiana, United States, 46260
        • Investigator Site
    • Iowa
      • Clive, Iowa, United States, 50325
        • Investigator Site
      • Iowa City, Iowa, United States, 52242
        • Investigator Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Investigator Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Investigator Site
      • Louisville, Kentucky, United States, 40202
        • Investigator Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Investigator Site
      • New Orleans, Louisiana, United States, 70121
        • Investigator Site
      • Shreveport, Louisiana, United States, 71105
        • Investigator Site
      • Shreveport, Louisiana, United States, 71130
        • Investigator Site
    • Maine
      • South Portland, Maine, United States, 04106
        • Investigator Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Investigator Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Investigator Site
      • Boston, Massachusetts, United States, 02111
        • Investigator Site
      • Boston, Massachusetts, United States, 02118
        • Investigator Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0273
        • Investigator Site
      • Detroit, Michigan, United States, 48202
        • Investigator Site
      • Lansing, Michigan, United States, 48910
        • Investigator Site
      • Troy, Michigan, United States, 48085
        • Investigator Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407-3799
        • Investigator Site
      • Rochester, Minnesota, United States, 55905
        • Investigator Site
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Investigator Site
      • Saint Louis, Missouri, United States, 63141
        • Investigator Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Investigator Site
      • Omaha, Nebraska, United States, 68198-5990
        • Investigator Site
    • Nevada
      • Reno, Nevada, United States, 89503
        • Investigator Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08034
        • Investigator Site
      • Newark, New Jersey, United States, 07112
        • Investigator Site
      • Union, New Jersey, United States, 07002
        • Investigator Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Investigator Site
    • New York
      • Albany, New York, United States, 12208
        • Investigator Site
      • Bronx, New York, United States, 10467
        • Investigator Site
      • Brooklyn, New York, United States, 11215
        • Investigator Site
      • Fayetteville, New York, United States, 13066
        • Investigator Site
      • Hauppauge, New York, United States, 11788
        • Investigator Site
      • Mineola, New York, United States, 11501
        • Investigator Site
      • New Hyde Park, New York, United States, 11040
        • Investigator Site
      • New York, New York, United States, 10016
        • Investigator Site
      • New York, New York, United States, 10029
        • Investigator Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Investigator Site
      • Durham, North Carolina, United States, 27710
        • Investigator Site
      • Greensboro, North Carolina, United States, 27401
        • Investigator Site
      • Pinehurst, North Carolina, United States, 28374
        • Investigator Site
    • Ohio
      • Canton, Ohio, United States, 44708
        • Investigator Site
      • Cincinnati, Ohio, United States, 43130
        • Investigator Site
      • Cincinnati, Ohio, United States, 45219
        • Investigator Site
      • Cincinnati, Ohio, United States, 45242-5223
        • Investigator Site
      • Cincinnati, Ohio, United States, 45267-2564
        • Investigator Site
      • Columbus, Ohio, United States, 43210
        • Investigator Site
      • Columbus, Ohio, United States, 43213
        • Investigator Site
      • Dayton, Ohio, United States, 45459
        • Investigator Site
      • Lima, Ohio, United States, 45801
        • Investigator Site
      • Middleburg Heights, Ohio, United States, 44130
        • Investigator Site
      • Toledo, Ohio, United States, 43614
        • Investigator Site
      • Wooster, Ohio, United States, 44691
        • Investigator Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Investigator Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Investigator Site
      • Portland, Oregon, United States, 97225
        • Investigator Site
      • Portland, Oregon, United States, 97239-3098
        • Investigator Site
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Investigator Site
      • Doylestown, Pennsylvania, United States, 18907
        • Investigator Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Investigator Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Investigator Site
      • Philadelphia, Pennsylvania, United States, 19140
        • Investigator Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Investigator Site
      • Wynnewood, Pennsylvania, United States, 19096
        • Investigator Site
      • York, Pennsylvania, United States, 17402
        • Investigator Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Investigator Site
      • Charleston, South Carolina, United States, 29425
        • Investigator Site
      • Columbia, South Carolina, United States, 29204
        • Investigator Site
      • Rock Hill, South Carolina, United States, 29732
        • Investigator Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Investigator Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Investigator Site
      • Memphis, Tennessee, United States, 38157
        • Investigator Site
    • Texas
      • Dallas, Texas, United States, 75390-8550
        • Investigator Site
      • Houston, Texas, United States, 77030
        • Investigator Site
      • Plano, Texas, United States, 75093
        • Investigator Site
      • San Antonio, Texas, United States, 78229
        • Investigator Site
      • Sherman, Texas, United States, 75092
        • Investigator Site
      • Temple, Texas, United States, 76508-0001
        • Investigator Site
      • Weslaco, Texas, United States, 78596
        • Investigator Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Investigator Site
      • Falls Church, Virginia, United States, 22042
        • Investigator Site
      • Norfolk, Virginia, United States, 23507
        • Investigator Site
      • Richmond, Virginia, United States, 23298-0050
        • Investigator Site
    • Washington
      • Seattle, Washington, United States, 98195
        • Investigator Site
      • Spokane, Washington, United States, 99204
        • Investigator Site
      • Tacoma, Washington, United States, 98405
        • Investigator Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Investigator Site
      • Milwaukee, Wisconsin, United States, 53215
        • Investigator Site
      • Milwaukee, Wisconsin, United States, 53226
        • Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients newly treated with Opsumit

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Opsumit (macitentan)
10 mg tablets
Drug: Opsumit (macitentan)
10 mg tablets
Other Names:
  • ACT-064992

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To estimate incidence rates for specified outcomes.
Time Frame: 1 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period.
Time Frame: 1 year
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
To describe PAH treatment patterns at enrollment and during observation period.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Actelion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: V McLaughlin, MD, Chair of the OPUS scientific committee (OSC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC-055-503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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