OPsumit USers Registry (OPUS)

August 12, 2020 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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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
      • Oakbrook Terrace, Illinois, United States, 60181
        • Investigator site
      • Oakbrook Terrace, 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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
Opsumit (macitentan)
10 mg tablets
Drug: Opsumit (macitentan)
10 mg tablets
Other Names:
  • ACT-064992

What is the study measuring?

Primary Outcome Measures

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

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

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

Actelion

Investigators

  • 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)

April 30, 2014

Primary Completion (Actual)

April 24, 2020

Study Completion (Actual)

April 24, 2020

Study Registration Dates

First Submitted

April 29, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

April 30, 2014

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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