OPsumit brugerregister (OPUS)
USA-baserede, observationelle, lægemiddelregister af Opsumit® (Macitentan) Nye brugere i klinisk praksis
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Kontakter og lokationer
Studiesteder
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Alabama
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Mobile, Alabama, Forenede Stater, 36604
- Investigator Site
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Arizona
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Phoenix, Arizona, Forenede Stater, 85032
- Investigator Site
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Phoenix, Arizona, Forenede Stater, 85006
- Investigator Site
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Phoenix, Arizona, Forenede Stater, 85054
- Investigator Site
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California
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Fullerton, California, Forenede Stater, 92835
- Investigator Site
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La Jolla, California, Forenede Stater, 92093
- Investigator Site
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Loma Linda, California, Forenede Stater, 92354
- Investigator Site
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Los Angeles, California, Forenede Stater, 90033
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Los Angeles, California, Forenede Stater, 90095-1690
- Investigator Site
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Los Angeles, California, Forenede Stater, 90211
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Moreno Valley, California, Forenede Stater, 92553
- Investigator Site
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San Juan Capistrano, California, Forenede Stater, 92675
- Investigator Site
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Santa Barbara, California, Forenede Stater, 93105
- Investigator Site
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Stanford, California, Forenede Stater, 94305
- Investigator Site
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Investigator Site
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Denver, Colorado, Forenede Stater, 80206
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Greeley, Colorado, Forenede Stater, 80631
- Investigator Site
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Wheat Ridge, Colorado, Forenede Stater, 80033
- Investigator Site
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06515
- Investigator Site
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Delaware
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Newark, Delaware, Forenede Stater, 19718
- Investigator Site
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20007
- Investigator Site
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Florida
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Brandon, Florida, Forenede Stater, 33511
- Investigator Site
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Celebration, Florida, Forenede Stater, 34747
- Investigator Site
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Clermont, Florida, Forenede Stater, 34711
- Investigator Site
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Fort Lauderdale, Florida, Forenede Stater, 33316
- Investigator Site
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Gainesville, Florida, Forenede Stater, 32610
- Investigator Site
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Hudson, Florida, Forenede Stater, 34667
- Investigator Site
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Jacksonville, Florida, Forenede Stater, 32207
- Investigator Site
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Jacksonville, Florida, Forenede Stater, 32209
- Investigator Site
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Kissimmee, Florida, Forenede Stater, 34741
- Investigator Site
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Leesburg, Florida, Forenede Stater, 34748
- Investigator Site
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Melbourne, Florida, Forenede Stater, 32901
- Investigator Site
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Miami, Florida, Forenede Stater, 33136
- Investigator Site
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Miami, Florida, Forenede Stater, 33125
- Investigator Site
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Miami Beach, Florida, Forenede Stater, 33140
- Investigator Site
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Orlando, Florida, Forenede Stater, 32803
- Investigator Site
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Pensacola, Florida, Forenede Stater, 32504
- Investigator Site
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Saint Petersburg, Florida, Forenede Stater, 33701
- Investigator Site
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Saint Petersburg, Florida, Forenede Stater, 33704
- Investigator Site
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Saint Petersburg, Florida, Forenede Stater, 33707
- Investigator Site
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Sebring, Florida, Forenede Stater, 33870
- Investigator Site
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South Miami, Florida, Forenede Stater, 33143
- Investigator Site
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Tampa, Florida, Forenede Stater, 33606
- Investigator Site
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Weston, Florida, Forenede Stater, 33331
- Investigator Site
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Zephyrhills, Florida, Forenede Stater, 33542
- Investigator Site
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Georgia
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Marietta, Georgia, Forenede Stater, 30060
- Investigator Site
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- Investigator Site
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Investigator Site
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Oak Brook, Illinois, Forenede Stater, 60181
- Investigator Site
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Oak Brook, Illinois, Forenede Stater, 60523
- Investigator Site
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Indiana
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Carmel, Indiana, Forenede Stater, 46032
- Investigator Site
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Fort Wayne, Indiana, Forenede Stater, 46804
- Investigator Site
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Greenwood, Indiana, Forenede Stater, 46143
- Investigator Site
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Indianapolis, Indiana, Forenede Stater, 46260
- Investigator Site
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Iowa
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Clive, Iowa, Forenede Stater, 50325
- Investigator Site
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Iowa City, Iowa, Forenede Stater, 52242
- Investigator Site
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- Investigator Site
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
- Investigator Site
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Louisville, Kentucky, Forenede Stater, 40202
- Investigator Site
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70112
- Investigator Site
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New Orleans, Louisiana, Forenede Stater, 70121
- Investigator Site
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Shreveport, Louisiana, Forenede Stater, 71105
- Investigator Site
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Shreveport, Louisiana, Forenede Stater, 71130
- Investigator Site
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Maine
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South Portland, Maine, Forenede Stater, 04106
- Investigator Site
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- Investigator Site
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Investigator Site
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Boston, Massachusetts, Forenede Stater, 02111
- Investigator Site
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Boston, Massachusetts, Forenede Stater, 02118
- Investigator Site
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109-0273
- Investigator Site
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Detroit, Michigan, Forenede Stater, 48202
- Investigator Site
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Lansing, Michigan, Forenede Stater, 48910
- Investigator Site
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Troy, Michigan, Forenede Stater, 48085
- Investigator Site
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55407-3799
- Investigator Site
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Rochester, Minnesota, Forenede Stater, 55905
- Investigator Site
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Missouri
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Saint Louis, Missouri, Forenede Stater, 63104
- Investigator Site
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Saint Louis, Missouri, Forenede Stater, 63141
- Investigator Site
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68506
- Investigator Site
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Omaha, Nebraska, Forenede Stater, 68198-5990
- Investigator Site
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Nevada
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Reno, Nevada, Forenede Stater, 89503
- Investigator Site
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New Jersey
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Cherry Hill, New Jersey, Forenede Stater, 08034
- Investigator Site
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Newark, New Jersey, Forenede Stater, 07112
- Investigator Site
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Union, New Jersey, Forenede Stater, 07002
- Investigator Site
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87106
- Investigator Site
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New York
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Albany, New York, Forenede Stater, 12208
- Investigator Site
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Bronx, New York, Forenede Stater, 10467
- Investigator Site
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Brooklyn, New York, Forenede Stater, 11215
- Investigator Site
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Fayetteville, New York, Forenede Stater, 13066
- Investigator Site
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Hauppauge, New York, Forenede Stater, 11788
- Investigator Site
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Mineola, New York, Forenede Stater, 11501
- Investigator Site
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New Hyde Park, New York, Forenede Stater, 11040
- Investigator Site
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New York, New York, Forenede Stater, 10016
- Investigator Site
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New York, New York, Forenede Stater, 10029
- Investigator Site
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- Investigator Site
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Durham, North Carolina, Forenede Stater, 27710
- Investigator Site
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Greensboro, North Carolina, Forenede Stater, 27401
- Investigator Site
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Pinehurst, North Carolina, Forenede Stater, 28374
- Investigator Site
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Ohio
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Canton, Ohio, Forenede Stater, 44708
- Investigator Site
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Cincinnati, Ohio, Forenede Stater, 43130
- Investigator Site
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Cincinnati, Ohio, Forenede Stater, 45219
- Investigator Site
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Cincinnati, Ohio, Forenede Stater, 45242-5223
- Investigator Site
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Cincinnati, Ohio, Forenede Stater, 45267-2564
- Investigator Site
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Columbus, Ohio, Forenede Stater, 43210
- Investigator Site
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Columbus, Ohio, Forenede Stater, 43213
- Investigator Site
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Dayton, Ohio, Forenede Stater, 45459
- Investigator Site
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Lima, Ohio, Forenede Stater, 45801
- Investigator Site
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Middleburg Heights, Ohio, Forenede Stater, 44130
- Investigator Site
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Toledo, Ohio, Forenede Stater, 43614
- Investigator Site
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Wooster, Ohio, Forenede Stater, 44691
- Investigator Site
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73112
- Investigator Site
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Oregon
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Portland, Oregon, Forenede Stater, 97210
- Investigator Site
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Portland, Oregon, Forenede Stater, 97225
- Investigator Site
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Portland, Oregon, Forenede Stater, 97239-3098
- Investigator Site
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Pennsylvania
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Abington, Pennsylvania, Forenede Stater, 19001
- Investigator Site
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Doylestown, Pennsylvania, Forenede Stater, 18907
- Investigator Site
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Investigator Site
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Investigator Site
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Philadelphia, Pennsylvania, Forenede Stater, 19140
- Investigator Site
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Investigator Site
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Wynnewood, Pennsylvania, Forenede Stater, 19096
- Investigator Site
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York, Pennsylvania, Forenede Stater, 17402
- Investigator Site
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South Carolina
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Anderson, South Carolina, Forenede Stater, 29621
- Investigator Site
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Charleston, South Carolina, Forenede Stater, 29425
- Investigator Site
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Columbia, South Carolina, Forenede Stater, 29204
- Investigator Site
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Rock Hill, South Carolina, Forenede Stater, 29732
- Investigator Site
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57108
- Investigator Site
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404
- Investigator Site
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Memphis, Tennessee, Forenede Stater, 38157
- Investigator Site
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Texas
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Dallas, Texas, Forenede Stater, 75390-8550
- Investigator Site
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Houston, Texas, Forenede Stater, 77030
- Investigator Site
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Plano, Texas, Forenede Stater, 75093
- Investigator Site
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San Antonio, Texas, Forenede Stater, 78229
- Investigator Site
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Sherman, Texas, Forenede Stater, 75092
- Investigator Site
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Temple, Texas, Forenede Stater, 76508-0001
- Investigator Site
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Weslaco, Texas, Forenede Stater, 78596
- Investigator Site
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- Investigator Site
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Falls Church, Virginia, Forenede Stater, 22042
- Investigator Site
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Norfolk, Virginia, Forenede Stater, 23507
- Investigator Site
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Richmond, Virginia, Forenede Stater, 23298-0050
- Investigator Site
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Washington
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Seattle, Washington, Forenede Stater, 98195
- Investigator Site
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Spokane, Washington, Forenede Stater, 99204
- Investigator Site
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Tacoma, Washington, Forenede Stater, 98405
- Investigator Site
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
- Investigator Site
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Milwaukee, Wisconsin, Forenede Stater, 53215
- Investigator Site
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Investigator Site
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Guaynabo, Puerto Rico, 00968
- Investigator Site
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Ponce, Puerto Rico, 00716
- Investigator Site
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
Patienter, der er nybehandlet med Opsumit, defineret som en ny bruger af terapi, påbegyndt ≤ 30 dage før indskrivningsbesøg.
Signeret ICF
Ekskluderingskriterier:
Tidligere bruger af Opsumit defineret som patient, der påbegyndte behandling >30 dage før tilmelding.
Patienter, der er indskrevet i eventuelle igangværende kliniske forsøg
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Antal grupper/kohorter
Kohorter og interventioner
Gruppe / kohorteGruppe / kohorte |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Opsumit (macitentan)
10 mg tabletter
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10 mg tabletter
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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At estimere incidensrater for specificerede resultater.
Tidsramme: 1 år
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Leverprøveabnormaliteter/Forekomst af leverbivirkninger (HAE'er)/Forekomst af enhver anden AE’er/ Seponering af Opsumit og årsag til at stoppe behandlingen/ Hospitalsindlæggelse og død.
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1 år
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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At beskrive demografiske og kliniske karakteristika for patienter behandlet med Opsumit ved indskrivning og i observationsperioden.
Tidsramme: 1 år
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1 år
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Andre resultatmål
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
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At beskrive PAH-behandlingsmønstre ved indskrivning og i observationsperiode.
Tidsramme: 1 år
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1 år
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studiestol: V McLaughlin, MD, Chair of the OPUS scientific committee (OSC)
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- AC-055-503
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .