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OPsumit USers Registry (OPUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02126943
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Actelion

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.

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Drug: Opsumit (macitentan)

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice
Actual Study Start Date : April 30, 2014
Actual Primary Completion Date : April 24, 2020
Actual Study Completion Date : April 24, 2020


Group/Cohort Intervention/treatment
Opsumit (macitentan)
10 mg tablets
Drug: Opsumit (macitentan)
10 mg tablets
Other Name: ACT-064992




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period. [ Time Frame: 1 year ]

Other Outcome Measures:
  1. To describe PAH treatment patterns at enrollment and during observation period. [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients newly treated with Opsumit
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126943


Locations
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United States, Alabama
Investigator Site
Mobile, Alabama, United States, 36604
United States, Arizona
Investigator Site
Phoenix, Arizona, United States, 85006
Investigator Site
Phoenix, Arizona, United States, 85032
Investigator Site
Phoenix, Arizona, United States, 85054
United States, California
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Fullerton, California, United States, 92835
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La Jolla, California, United States, 92093
Investigator Site
Loma Linda, California, United States, 92354
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Los Angeles, California, United States, 90033
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Los Angeles, California, United States, 90095-1690
Investigator Site
Los Angeles, California, United States, 90211
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Moreno Valley, California, United States, 92553
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San Juan Capistrano, California, United States, 92675
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Santa Barbara, California, United States, 93105
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Stanford, California, United States, 94305
United States, Colorado
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Aurora, Colorado, United States, 80045
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Denver, Colorado, United States, 80206
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Greeley, Colorado, United States, 80631
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Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Investigator Site
New Haven, Connecticut, United States, 06515
United States, Delaware
Investigator Site
Newark, Delaware, United States, 19718
United States, District of Columbia
Investigator Site
Washington, District of Columbia, United States, 20007
United States, Florida
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Brandon, Florida, United States, 33511
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Celebration, Florida, United States, 34747
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Clermont, Florida, United States, 34711
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Fort Lauderdale, Florida, United States, 33316
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Gainesville, Florida, United States, 32610
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Hudson, Florida, United States, 34667
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Jacksonville, Florida, United States, 32207
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Jacksonville, Florida, United States, 32209
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Kissimmee, Florida, United States, 34741
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Leesburg, Florida, United States, 34748
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Melbourne, Florida, United States, 32901
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Miami Beach, Florida, United States, 33140
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Miami, Florida, United States, 33125
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Miami, Florida, United States, 33136
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Orlando, Florida, United States, 32803
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Pensacola, Florida, United States, 32504
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Saint Petersburg, Florida, United States, 33701
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Saint Petersburg, Florida, United States, 33704
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Saint Petersburg, Florida, United States, 33707
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Sebring, Florida, United States, 33870
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South Miami, Florida, United States, 33143
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Tampa, Florida, United States, 33606
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Weston, Florida, United States, 33331
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Zephyrhills, Florida, United States, 33542
United States, Georgia
Investigator Site
Marietta, Georgia, United States, 30060
United States, Hawaii
Investigator Site
Honolulu, Hawaii, United States, 96813
United States, Illinois
Investigator Site
Chicago, Illinois, United States, 60611
Investigator Site
Oakbrook Terrace, Illinois, United States, 60181
Investigator Site
Oakbrook Terrace, Illinois, United States, 60523
United States, Indiana
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Carmel, Indiana, United States, 46032
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Fort Wayne, Indiana, United States, 46804
Investigator Site
Greenwood, Indiana, United States, 46143
Investigator Site
Indianapolis, Indiana, United States, 46260
United States, Iowa
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Clive, Iowa, United States, 50325
Investigator Site
Iowa City, Iowa, United States, 52242
United States, Kansas
Investigator Site
Kansas City, Kansas, United States, 66160
United States, Kentucky
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Lexington, Kentucky, United States, 40536
Investigator Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
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New Orleans, Louisiana, United States, 70112
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New Orleans, Louisiana, United States, 70121
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Shreveport, Louisiana, United States, 71105
Investigator Site
Shreveport, Louisiana, United States, 71130
United States, Maine
Investigator Site
South Portland, Maine, United States, 04106
United States, Maryland
Investigator Site
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Investigator Site
Boston, Massachusetts, United States, 02111
Investigator Site
Boston, Massachusetts, United States, 02114
Investigator Site
Boston, Massachusetts, United States, 02118
United States, Michigan
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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
United States, Minnesota
Investigator Site
Minneapolis, Minnesota, United States, 55407-3799
Investigator Site
Rochester, Minnesota, United States, 55905
United States, Missouri
Investigator Site
Saint Louis, Missouri, United States, 63104
Investigator Site
Saint Louis, Missouri, United States, 63141
United States, Nebraska
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Lincoln, Nebraska, United States, 68506
Investigator Site
Omaha, Nebraska, United States, 68198-5990
United States, Nevada
Investigator Site
Reno, Nevada, United States, 89503
United States, New Jersey
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Cherry Hill, New Jersey, United States, 08034
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Newark, New Jersey, United States, 07112
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Union, New Jersey, United States, 07002
United States, New Mexico
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Albuquerque, New Mexico, United States, 87106
United States, New York
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Albany, New York, United States, 12208
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Bronx, New York, United States, 10467
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Brooklyn, New York, United States, 11215
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Fayetteville, New York, United States, 13066
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Hauppauge, New York, United States, 11788
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Mineola, New York, United States, 11501
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New Hyde Park, New York, United States, 11040
Investigator Site
New York, New York, United States, 10016
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New York, New York, United States, 10029
United States, North Carolina
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Chapel Hill, North Carolina, United States, 27599
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Durham, North Carolina, United States, 27710
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Greensboro, North Carolina, United States, 27401
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Pinehurst, North Carolina, United States, 28374
United States, Ohio
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Canton, Ohio, United States, 44708
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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
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Columbus, Ohio, United States, 43210
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Columbus, Ohio, United States, 43213
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Dayton, Ohio, United States, 45459
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Lima, Ohio, United States, 45801
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Middleburg Heights, Ohio, United States, 44130
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Toledo, Ohio, United States, 43614
Investigator Site
Wooster, Ohio, United States, 44691
United States, Oklahoma
Investigator Site
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Investigator Site
Portland, Oregon, United States, 97210
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Portland, Oregon, United States, 97225
Investigator Site
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
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Abington, Pennsylvania, United States, 19001
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Doylestown, Pennsylvania, United States, 18907
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Philadelphia, Pennsylvania, United States, 19104
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Philadelphia, Pennsylvania, United States, 19107
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Philadelphia, Pennsylvania, United States, 19140
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Pittsburgh, Pennsylvania, United States, 15213
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Wynnewood, Pennsylvania, United States, 19096
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York, Pennsylvania, United States, 17402
United States, South Carolina
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Anderson, South Carolina, United States, 29621
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Charleston, South Carolina, United States, 29425
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Columbia, South Carolina, United States, 29204
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Rock Hill, South Carolina, United States, 29732
United States, South Dakota
Investigator Site
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
Investigator Site
Chattanooga, Tennessee, United States, 37404
Investigator Site
Memphis, Tennessee, United States, 38157
United States, Texas
Investigator Site
Dallas, Texas, United States, 75390-8550
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Houston, Texas, United States, 77030
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Plano, Texas, United States, 75093
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San Antonio, Texas, United States, 78229
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Sherman, Texas, United States, 75092
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Temple, Texas, United States, 76508-0001
Investigator Site
Weslaco, Texas, United States, 78596
United States, Virginia
Investigator Site
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
United States, Washington
Investigator Site
Seattle, Washington, United States, 98195
Investigator Site
Spokane, Washington, United States, 99204
Investigator Site
Tacoma, Washington, United States, 98405
United States, Wisconsin
Investigator Site
Madison, Wisconsin, United States, 53792
Investigator Site
Milwaukee, Wisconsin, United States, 53215
Investigator Site
Milwaukee, Wisconsin, United States, 53226
Puerto Rico
Investigator Site
Guaynabo, Puerto Rico, 00968
Investigator Site
Ponce, Puerto Rico, 00716
Sponsors and Collaborators
Actelion
Investigators
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Study Chair: V McLaughlin, MD Chair of the OPUS scientific committee (OSC)
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02126943    
Other Study ID Numbers: AC-055-503
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Keywords provided by Actelion:
PAH
pulmonary arterial hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Macitentan
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists