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A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension (STRIDE-3)

29. marts 2012 opdateret af: Pfizer

A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension

This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Open-label extension

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1192

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Capital Federal, Argentina, C1039AAO
        • Pfizer Investigational Site
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1416ASA
        • Pfizer Investigational Site
  • Australien
      • Chermside, Australien, QLD 4032
        • Pfizer Investigational Site
    • New South Wales
      • Darlinghurst, New South Wales, Australien, 2010
        • Pfizer Investigational Site
    • Queensland
      • Chermside Q, Queensland, Australien, 4032
        • Pfizer Investigational Site
    • Victoria
      • Melbourne, Victoria, Australien, 3004
        • Pfizer Investigational Site
  • Belgien
      • Bruxelles, Belgien, 1070
        • Pfizer Investigational Site
      • Leuven, Belgien, B - 3000
        • Pfizer Investigational Site
  • Brasilien
      • Sao Paulo, Brasilien, 05403-000
        • Pfizer Investigational Site
    • MG
      • Belo Horizonte, MG, Brasilien, 30380-090
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brasilien, 90035-003
        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G1V 4G5
        • Pfizer Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T6G 2B7
        • Pfizer Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Pfizer Investigational Site
  • Det Forenede Kongerige
      • Glasgow, Det Forenede Kongerige, G11 6NT
        • Pfizer Investigational Site
      • London, Det Forenede Kongerige, NW3 2QG
        • Pfizer Investigational Site
      • Newcastle, Det Forenede Kongerige, NE7 7DN
        • Pfizer Investigational Site
    • Cambridgeshire
      • Papworth Everard, Cambridgeshire, Det Forenede Kongerige, CB3 8RB
        • Pfizer Investigational Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, Forenede Stater, 35294
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85013
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, Forenede Stater, 90073
        • Pfizer Investigational Site
      • San Francisco, California, Forenede Stater, 94143-0124
        • Pfizer Investigational Site
      • Torrence, California, Forenede Stater, 90502
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, Forenede Stater, 80262
        • Pfizer Investigational Site
      • Denver, Colorado, Forenede Stater, 80218
        • Pfizer Investigational Site
    • Florida
      • Sarasota, Florida, Forenede Stater, 34233
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Pfizer Investigational Site
      • Augusta, Georgia, Forenede Stater, 30912
        • Pfizer Investigational Site
      • Decatur, Georgia, Forenede Stater, 30033
        • Pfizer Investigational Site
      • Decatur, Georgia, Forenede Stater, 30030
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Pfizer Investigational Site
      • New Orleans, Louisiana, Forenede Stater, 70112-1393
        • Pfizer Investigational Site
    • Maine
      • Portland, Maine, Forenede Stater, 04102
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Pfizer Investigational Site
      • Boston, Massachusetts, Forenede Stater, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, Forenede Stater, 02111
        • Pfizer Investigational Site
      • Boston, Massachusetts, Forenede Stater, 02218
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109-0570
        • Pfizer Investigational Site
      • Detroit, Michigan, Forenede Stater, 48201
        • Pfizer Investigational Site
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, Forenede Stater, 08903-0019
        • Pfizer Investigational Site
    • New York
      • New York, New York, Forenede Stater, 10032
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Pfizer Investigational Site
      • Cleveland, Ohio, Forenede Stater, 44195
        • Pfizer Investigational Site
      • Columbus, Ohio, Forenede Stater, 43210
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Pfizer Investigational Site
      • Nashville, Tennessee, Forenede Stater, 37232-5735
        • Pfizer Investigational Site
      • Nashville, Tennessee, Forenede Stater, 37232-2650
        • Pfizer Investigational Site
    • Texas
      • Galveston, Texas, Forenede Stater, 77555-0561
        • Pfizer Investigational Site
      • Houston, Texas, Forenede Stater, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84143
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Pfizer Investigational Site
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Pfizer Investigational Site
  • Frankrig
      • Clamart Cedex, Frankrig, 92141
        • Pfizer Investigational Site
      • GRENOBLE Cedex 09, Frankrig, 38043
        • Pfizer Investigational Site
      • Strasbourg, Frankrig, 67098
        • Pfizer Investigational Site
  • Holland
      • Amsterdam, Holland, 1081 HV
        • Pfizer Investigational Site
  • Israel
      • Petach Tikva, Israel, 49100
        • Pfizer Investigational Site
      • Tel-Hashomer, Ramat Gan, Israel, 52601
        • Pfizer Investigational Site
  • Italien
      • Bologna, Italien, 40138
        • Pfizer Investigational Site
  • Mexico
    • CP
      • Monterrey, CP, Mexico, 64020
        • Pfizer Investigational Site
    • DF
      • Tlalpan, DF, Mexico, 14080
        • Pfizer Investigational Site
    • N.l.
      • Monterrey, N.l., Mexico, 64360
        • Pfizer Investigational Site
  • Polen
      • Krakow, Polen, 31-202
        • Pfizer Investigational Site
      • Warszawa, Polen, 01-138
        • Pfizer Investigational Site
      • Zabrze, Polen, 41-800
        • Pfizer Investigational Site
  • Spanien
      • Barcelona, Spanien, 08036
        • Pfizer Investigational Site
  • Tyskland
      • Berlin, Tyskland, 14050
        • Pfizer Investigational Site
      • Dresden, Tyskland, 01307
        • Pfizer Investigational Site
      • Giessen, Tyskland, 35392
        • Pfizer Investigational Site
      • Greifswald, Tyskland, 17487
        • Pfizer Investigational Site
      • Hannover, Tyskland, 30625
        • Pfizer Investigational Site
      • Heidelberg, Tyskland, 69120
        • Pfizer Investigational Site
      • Leipzig, Tyskland, 04103
        • Pfizer Investigational Site
      • Regensburg, Tyskland, 93053
        • Pfizer Investigational Site
  • Østrig
      • Graz, Østrig, 8036
        • Pfizer Investigational Site
      • Wien, Østrig, 1090
        • Pfizer Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 75 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of Pulmonary Arterial Hypertension (PAH) confirmed by cardiac catheterization.
  • Current diagnosis of WHO group 1 PAH with functional class 2, 3, or 4 symptoms.

Exclusion Criteria:

  • Has portal hypertension or chronic liver disease.
  • Has history of left sided heart disease or significant cardiac disease.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sitaxsentan
Medicin: Sitaxsentan
Sitaxsentan 100 mg tablets once daily
Andre navne:
  • Sitaxentan

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Day 1 up to 82 months
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.
Day 1 up to 82 months
The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN)
Tidsramme: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN
Tidsramme: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Percentage of Participants With Total Bilirubin > 1.5 x ULN
Tidsramme: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Percentage of Participants With Laboratory Test Abnormalities (Hematology)
Tidsramme: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Percentage of Participants With Laboratory Test Abnormalities (Chemistry)
Tidsramme: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Percentage of Participants With Laboratory Test Abnormalities (Urinalysis)
Tidsramme: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Percentage of Participants With Anticoagulant Use
Tidsramme: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan.
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Percentage of Participants With Elevated International Normalize Ratio (INR)
Tidsramme: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Elevated INR in participants who took warfarin, warfarin derivatives, other anticoagulant and no anticoagulants. Elevated INR defined as > 3.5. Percentage calculated using number of participants with INR data as the denominator.
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance
Tidsramme: Weeks 28,60,72,84,96,104, Transition Visit up to 82 months
Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement.
Weeks 28,60,72,84,96,104, Transition Visit up to 82 months
Percentage of Participants With Vital Sign Results of Potential Clinical Importance
Tidsramme: Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months
Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement.
Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months
Percentage of Participants With Abnormal Prothrombin Time (PT)
Tidsramme: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT)
Tidsramme: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2003

Primær færdiggørelse (Faktiske)

1. juli 2011

Studieafslutning (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først indsendt

9. december 2008

Først indsendt, der opfyldte QC-kriterier

16. december 2008

Først opslået (Skøn)

18. december 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. april 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. marts 2012

Sidst verificeret

1. november 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B1321007
  • FPH03

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 .

Kliniske forsøg med Pulmonal arteriel hypertension

Kliniske forsøg med Sitaxsentan

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gabon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner