Retrospektiv diagramgennemgang af førstegangsbrugere af Opsumit® (Macitentan) i USA (OrPHeUS)
Multicenter, retrospektiv diagramgennemgang af førstegangsbrugere af Opsumit® (Macitentan) i USA
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Kontakter og lokationer
Studiesteder
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85006
- Pulmonary Associates
-
Phoenix, Arizona, Forenede Stater, 85054
- Mayo Clinic - Arizona
-
Phoenix, Arizona, Forenede Stater, 85032
- Cardiovascular Consultants
-
-
California
-
La Jolla, California, Forenede Stater, 93093
- University of California San Diego
-
Loma Linda, California, Forenede Stater, 92354
- Loma Linda University Medical Center
-
Los Angeles, California, Forenede Stater, 90033
- University of Southern California
-
Los Angeles, California, Forenede Stater, 90095-1690
- David Geffen School of Medicine at University of California Los Angeles
-
San Francisco, California, Forenede Stater, 94143
- UCSF School of Medicine
-
San Juan Capistrano, California, Forenede Stater, 92675
- Paloma Medical Group
-
Santa Barbara, California, Forenede Stater, 93105
- Santa Barbara Cottage Hospital
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80045
- University of Colorado
-
Denver, Colorado, Forenede Stater, 80206
- National Jewish Health
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06520
- Yale University
-
-
Delaware
-
Newark, Delaware, Forenede Stater, 19718
- Christiana Care Health Services
-
-
District of Columbia
-
Washington, District of Columbia, Forenede Stater, 20007
- MedStar Georgetown University Hospital
-
-
Florida
-
Brandon, Florida, Forenede Stater, 33511
- Bay Area Cardiology Associates
-
Celebration, Florida, Forenede Stater, 34747
- Florida Lung, Asthma and Sleep Specialists
-
Fort Lauderdale, Florida, Forenede Stater, 33316
- Frank Hull, MD, PA
-
Gainesville, Florida, Forenede Stater, 32610
- University of Florida
-
Hudson, Florida, Forenede Stater, 34667
- West Pasco Pulmonary Associates
-
Jacksonville, Florida, Forenede Stater, 32209
- Saint Vincent's Medical Center
-
Leesburg, Florida, Forenede Stater, 34748
- Medical Research of Central Florida
-
Melbourne, Florida, Forenede Stater, 32901
- Independent Lung Associates
-
Miami, Florida, Forenede Stater, 33136
- University of Miami
-
Miami Beach, Florida, Forenede Stater, 33140
- Mount Sinai Comprehensive Cancer Center
-
Orlando, Florida, Forenede Stater, 32803
- Central Florida Pulmonary Group, P.A. - Downtown Orlando Office
-
Saint Petersburg, Florida, Forenede Stater, 33704
- Coastal Pulmonary and Critical Care
-
Sebring, Florida, Forenede Stater, 33870
- Bassetti Medical Research Inc
-
South Miami, Florida, Forenede Stater, 33143
- Cardiovascular Medicine Associates
-
Tampa, Florida, Forenede Stater, 33606
- University of South Florida
-
Weston, Florida, Forenede Stater, 33331
- Cleveland Clinic Florida Hospital
-
Zephyrhills, Florida, Forenede Stater, 33542
- Florida Medical Clinic
-
-
Georgia
-
Austell, Georgia, Forenede Stater, 30106
- Piedmont Healthcare
-
Columbus, Georgia, Forenede Stater, 31904
- Southeastern Cardiology Associates
-
Marietta, Georgia, Forenede Stater, 30060
- Wellstar Marietta Pulmonary Medicine
-
-
Idaho
-
Shelley, Idaho, Forenede Stater, 83274
- Bingham Memorial Hospital
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
-
-
Indiana
-
Carmel, Indiana, Forenede Stater, 46032
- IU Health Physicians Pulmonary & Critical Care
-
Fort Wayne, Indiana, Forenede Stater, 46804
- Lutheran Hospital
-
Greenwood, Indiana, Forenede Stater, 46143
- Indiana Internal Medicine Consultants
-
Indianapolis, Indiana, Forenede Stater, 46260
- St. Vincent Medical Group, Inc.
-
-
Iowa
-
Clive, Iowa, Forenede Stater, 50325
- CIC Associates
-
Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospitals and Clinics
-
-
Kansas
-
Kansas City, Kansas, Forenede Stater, 66160
- The University of Kansas Physicians
-
-
Kentucky
-
Erlanger, Kentucky, Forenede Stater, 41018
- St. Elizabeth Healthcare Clinical Research Institute
-
Louisville, Kentucky, Forenede Stater, 40202
- Kentuckiana Pulmonary Associates
-
-
Louisiana
-
New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Medical Center
-
New Orleans, Louisiana, Forenede Stater, 70112
- LSU Health Sciences Center
-
Shreveport, Louisiana, Forenede Stater, 71105
- Pulmonary & Critical Care Specialists
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
-
Boston, Massachusetts, Forenede Stater, 02111
- Tufts Medical Center
-
Boston, Massachusetts, Forenede Stater, 02118
- Boston University Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Medical Center
-
Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Health System
-
Lansing, Michigan, Forenede Stater, 48912
- Sparrow Clinical Research Institute
-
Troy, Michigan, Forenede Stater, 48085
- Beaumont Medical Center
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55407-3799
- Minneapolis Heart Institute
-
-
Mississippi
-
Jackson, Mississippi, Forenede Stater, 39216
- University of Mississippi Medical Center
-
-
Missouri
-
Saint Louis, Missouri, Forenede Stater, 63141
- Mercy Hospital Saint Louis
-
Saint Louis, Missouri, Forenede Stater, 63104
- Saint Louis University
-
Saint Louis, Missouri, Forenede Stater, 63136
- Pulmonary Consultants Inc-St. Louis
-
-
Nebraska
-
Lincoln, Nebraska, Forenede Stater, 68506
- Nebraska Pulmonary Specialties, LLC
-
Omaha, Nebraska, Forenede Stater, 68198-5990
- University of Nebraska Medical Center
-
-
New Jersey
-
Newark, New Jersey, Forenede Stater, 07112
- Barnabas Health Ambulatory Care Center
-
Union, New Jersey, Forenede Stater, 07083
- Pulmonary and Critical Care Associates
-
-
New Mexico
-
Albuquerque, New Mexico, Forenede Stater, 87131-0001
- University of New Mexico
-
-
New York
-
Albany, New York, Forenede Stater, 12208
- Albany Medical Center
-
Bronx, New York, Forenede Stater, 10467
- Montefiore Medical Center - Bronx
-
Fayetteville, New York, Forenede Stater, 13066
- Pulmonary Health Physicians
-
Hauppauge, New York, Forenede Stater, 11788
- Stony Brook University Hospital
-
Middletown, New York, Forenede Stater, 10941
- Temple University Hospital
-
Mineola, New York, Forenede Stater, 11501
- Winthrop University Hospital, Clinical Trials Center
-
New York, New York, Forenede Stater, 10029
- Mount Sinai
-
-
North Carolina
-
Chapel Hill, North Carolina, Forenede Stater, 27599
- University of North Carolina Hospitals
-
Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45242
- University of Cincinnati
-
Columbus, Ohio, Forenede Stater, 43210
- Ohio State University, Wexner Medical Center
-
Columbus, Ohio, Forenede Stater, 43213
- Mount Carmel Medical Group
-
Dayton, Ohio, Forenede Stater, 45459
- Midwest Pulmonary & Sleep Research
-
Middleburg Heights, Ohio, Forenede Stater, 44130
- Southwest General Health Center
-
Toledo, Ohio, Forenede Stater, 43614
- The University of Toledo Medical Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73120
- Oklahoma Heart Hospital
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97210
- Legacy Research Institute
-
Portland, Oregon, Forenede Stater, 97225
- The Oregon Clinic
-
Portland, Oregon, Forenede Stater, 97201-3098
- Oregon Health & Science University
-
-
Pennsylvania
-
Doylestown, Pennsylvania, Forenede Stater, 18907
- Doylestown Health Cardiology, a division of Doylestown Health Physicians
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Thomas Jefferson University
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania Health System
-
Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Allegheny General Hospital
-
Wynnewood, Pennsylvania, Forenede Stater, 19096
- Lankenau Medical Center
-
-
South Carolina
-
Anderson, South Carolina, Forenede Stater, 29621
- AnMed Health Medical Center
-
Rock Hill, South Carolina, Forenede Stater, 29732
- Carolina Cardiology Associates
-
-
South Dakota
-
Sioux Falls, South Dakota, Forenede Stater, 57108
- Sioux Falls Cardiovascular PC
-
-
Tennessee
-
Chattanooga, Tennessee, Forenede Stater, 37404
- Memorial Research Center
-
Memphis, Tennessee, Forenede Stater, 38157
- Mid-South Pulmonary Specialists
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75390-8550
- University of Texas Southwestern Medical Center at Dallas
-
Denison, Texas, Forenede Stater, 75020
- Premier Pulmonary CC and Sleep Medicine, PA
-
Houston, Texas, Forenede Stater, 77030
- Houston Methodist Hospital
-
Houston, Texas, Forenede Stater, 77030
- University of Texas Health Science Center at Houston
-
Plano, Texas, Forenede Stater, 75093
- Baylor Regional Medical Center at Plano
-
Temple, Texas, Forenede Stater, 76508-0001
- Scott and White Memorial Hospital
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98195
- University of Washington
-
Spokane, Washington, Forenede Stater, 99204-4800
- Spokane Respiratory Consultants
-
Tacoma, Washington, Forenede Stater, 98405
- Cardiac Study Center
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53215
- Aurora Health Care - Saint Luke's Medical Center
-
-
-
-
-
Guaynabo, Puerto Rico, 00968
- CardioPulmonary Research Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
- Patienter, der startede Opsumit for første gang mellem 19. oktober 2013 og 31. december 2016 (inklusive)
- Patienter, hvis medicinske diagrammer er tilgængelige til dataindsamling
Ekskluderingskriterier:
- Patientdeltagelse i OPUS-registret
- Patientdeltagelse i ethvert klinisk forsøg, der involverer Opsumit-behandling eller macitentan-undersøgelsesprodukt
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Antal grupper/kohorter
Kohorter og interventioner
Gruppe / kohorteGruppe / kohorte |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Ikke anvendelig
Ikke anvendelig som ikke-interventionsundersøgelse
|
Ikke anvendelig som ikke-interventionsundersøgelse
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Estimering af incidensrater for uønskede hændelser
Tidsramme: Observationsperiode fra 19. okt 2013 til 31. marts 2017, Dataindsamling fra 1. apr 2017 til 30. jun 2018
|
Hyppighedsrater for abnorme leverprøver, forekomst af leverbivirkninger (HAE), forekomst af enhver anden bivirkning (AE), forekomst og årsag til seponering af Opsumit-behandling, hospitalsindlæggelse og død
|
Observationsperiode fra 19. okt 2013 til 31. marts 2017, Dataindsamling fra 1. apr 2017 til 30. jun 2018
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Beskrivelse af patienters demografiske karakteristika
Tidsramme: Observationsperiode fra 19. okt 2013 til 31. marts 2017, Dataindsamling fra 1. apr 2017 til 30. jun 2018
|
At beskrive demografiske karakteristika for patienter behandlet med Opsumit ved begyndelsen og i studieperioden
|
Observationsperiode fra 19. okt 2013 til 31. marts 2017, Dataindsamling fra 1. apr 2017 til 30. jun 2018
|
|
Beskrivelse af kliniske karakteristika hos patienter
Tidsramme: Observationsperiode fra 19. okt 2013 til 31. marts 2017, Dataindsamling fra 1. apr 2017 til 30. jun 2018
|
At beskrive kliniske karakteristika for patienter behandlet med Opsumit ved begyndelsen og i studieperioden
|
Observationsperiode fra 19. okt 2013 til 31. marts 2017, Dataindsamling fra 1. apr 2017 til 30. jun 2018
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
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 (Faktiske)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- AC-055-510
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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 .
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