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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. mars 2012 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Open-label extension

Studietype

Intervensjonell

Registrering (Faktiske)

1192

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Argentina
      • Capital Federal, Argentina, C1039AAO
        • Pfizer Investigational Site
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1416ASA
        • Pfizer Investigational Site
  • Australia
      • Chermside, Australia, QLD 4032
        • Pfizer Investigational Site
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Pfizer Investigational Site
    • Queensland
      • Chermside Q, Queensland, Australia, 4032
        • Pfizer Investigational Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Pfizer Investigational Site
  • Belgia
      • Bruxelles, Belgia, 1070
        • Pfizer Investigational Site
      • Leuven, Belgia, B - 3000
        • Pfizer Investigational Site
  • Brasil
      • Sao Paulo, Brasil, 05403-000
        • Pfizer Investigational Site
    • MG
      • Belo Horizonte, MG, Brasil, 30380-090
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brasil, 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
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, Forente stater, 35294
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, Forente stater, 85013
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, Forente stater, 90073
        • Pfizer Investigational Site
      • San Francisco, California, Forente stater, 94143-0124
        • Pfizer Investigational Site
      • Torrence, California, Forente stater, 90502
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, Forente stater, 80262
        • Pfizer Investigational Site
      • Denver, Colorado, Forente stater, 80218
        • Pfizer Investigational Site
    • Florida
      • Sarasota, Florida, Forente stater, 34233
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Pfizer Investigational Site
      • Augusta, Georgia, Forente stater, 30912
        • Pfizer Investigational Site
      • Decatur, Georgia, Forente stater, 30033
        • Pfizer Investigational Site
      • Decatur, Georgia, Forente stater, 30030
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Forente stater, 60637
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40536
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
        • Pfizer Investigational Site
      • New Orleans, Louisiana, Forente stater, 70112-1393
        • Pfizer Investigational Site
    • Maine
      • Portland, Maine, Forente stater, 04102
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Forente stater, 21205
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02118
        • Pfizer Investigational Site
      • Boston, Massachusetts, Forente stater, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, Forente stater, 02111
        • Pfizer Investigational Site
      • Boston, Massachusetts, Forente stater, 02218
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109-0570
        • Pfizer Investigational Site
      • Detroit, Michigan, Forente stater, 48201
        • Pfizer Investigational Site
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, Forente stater, 08903-0019
        • Pfizer Investigational Site
    • New York
      • New York, New York, Forente stater, 10032
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106
        • Pfizer Investigational Site
      • Cleveland, Ohio, Forente stater, 44195
        • Pfizer Investigational Site
      • Columbus, Ohio, Forente stater, 43210
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19140
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Pfizer Investigational Site
      • Nashville, Tennessee, Forente stater, 37232-5735
        • Pfizer Investigational Site
      • Nashville, Tennessee, Forente stater, 37232-2650
        • Pfizer Investigational Site
    • Texas
      • Galveston, Texas, Forente stater, 77555-0561
        • Pfizer Investigational Site
      • Houston, Texas, Forente stater, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, Forente stater, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, Forente stater, 84143
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Pfizer Investigational Site
      • Milwaukee, Wisconsin, Forente stater, 53215
        • Pfizer Investigational Site
  • Frankrike
      • Clamart Cedex, Frankrike, 92141
        • Pfizer Investigational Site
      • GRENOBLE Cedex 09, Frankrike, 38043
        • Pfizer Investigational Site
      • Strasbourg, Frankrike, 67098
        • Pfizer Investigational Site
  • Israel
      • Petach Tikva, Israel, 49100
        • Pfizer Investigational Site
      • Tel-Hashomer, Ramat Gan, Israel, 52601
        • Pfizer Investigational Site
  • Italia
      • Bologna, Italia, 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
  • Nederland
      • Amsterdam, Nederland, 1081 HV
        • 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
  • Spania
      • Barcelona, Spania, 08036
        • Pfizer Investigational Site
  • Storbritannia
      • Glasgow, Storbritannia, G11 6NT
        • Pfizer Investigational Site
      • London, Storbritannia, NW3 2QG
        • Pfizer Investigational Site
      • Newcastle, Storbritannia, NE7 7DN
        • Pfizer Investigational Site
    • Cambridgeshire
      • Papworth Everard, Cambridgeshire, Storbritannia, CB3 8RB
        • 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
  • Østerrike
      • Graz, Østerrike, 8036
        • Pfizer Investigational Site
      • Wien, Østerrike, 1090
        • Pfizer Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

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

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Sitaxsentan
Legemiddel: Sitaxsentan
Sitaxsentan 100 mg tablets once daily
Andre navn:
  • Sitaxentan

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2003

Primær fullføring (Faktiske)

1. juli 2011

Studiet fullført (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først innsendt

9. desember 2008

Først innsendt som oppfylte QC-kriteriene

16. desember 2008

Først lagt ut (Anslag)

18. desember 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. april 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mars 2012

Sist bekreftet

1. november 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • B1321007
  • FPH03

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere