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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 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Open-label extension

Studietyp

Interventionell

Inskrivning (Faktisk)

1192

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • Frankrike
      • Clamart Cedex, Frankrike, 92141
        • Pfizer Investigational Site
      • GRENOBLE Cedex 09, Frankrike, 38043
        • Pfizer Investigational Site
      • Strasbourg, Frankrike, 67098
        • Pfizer Investigational Site
  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, Förenta staterna, 35294
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, Förenta staterna, 85013
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, Förenta staterna, 90073
        • Pfizer Investigational Site
      • San Francisco, California, Förenta staterna, 94143-0124
        • Pfizer Investigational Site
      • Torrence, California, Förenta staterna, 90502
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, Förenta staterna, 80262
        • Pfizer Investigational Site
      • Denver, Colorado, Förenta staterna, 80218
        • Pfizer Investigational Site
    • Florida
      • Sarasota, Florida, Förenta staterna, 34233
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30322
        • Pfizer Investigational Site
      • Augusta, Georgia, Förenta staterna, 30912
        • Pfizer Investigational Site
      • Decatur, Georgia, Förenta staterna, 30033
        • Pfizer Investigational Site
      • Decatur, Georgia, Förenta staterna, 30030
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60637
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, Förenta staterna, 66160
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Förenta staterna, 40536
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna, 70112
        • Pfizer Investigational Site
      • New Orleans, Louisiana, Förenta staterna, 70112-1393
        • Pfizer Investigational Site
    • Maine
      • Portland, Maine, Förenta staterna, 04102
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21205
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02118
        • Pfizer Investigational Site
      • Boston, Massachusetts, Förenta staterna, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, Förenta staterna, 02111
        • Pfizer Investigational Site
      • Boston, Massachusetts, Förenta staterna, 02218
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48109-0570
        • Pfizer Investigational Site
      • Detroit, Michigan, Förenta staterna, 48201
        • Pfizer Investigational Site
    • Minnesota
      • Rochester, Minnesota, Förenta staterna, 55905
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, Förenta staterna, 08903-0019
        • Pfizer Investigational Site
    • New York
      • New York, New York, Förenta staterna, 10032
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27710
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, Förenta staterna, 44106
        • Pfizer Investigational Site
      • Cleveland, Ohio, Förenta staterna, 44195
        • Pfizer Investigational Site
      • Columbus, Ohio, Förenta staterna, 43210
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19140
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Förenta staterna, 15213
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29425
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37232
        • Pfizer Investigational Site
      • Nashville, Tennessee, Förenta staterna, 37232-5735
        • Pfizer Investigational Site
      • Nashville, Tennessee, Förenta staterna, 37232-2650
        • Pfizer Investigational Site
    • Texas
      • Galveston, Texas, Förenta staterna, 77555-0561
        • Pfizer Investigational Site
      • Houston, Texas, Förenta staterna, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, Förenta staterna, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84143
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Förenta staterna, 53226
        • Pfizer Investigational Site
      • Milwaukee, Wisconsin, Förenta staterna, 53215
        • 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
  • Kanada
      • Quebec, Kanada, G1V 4G5
        • Pfizer Investigational Site
    • Alberta
      • Calgary, Alberta, Kanada, T1Y 6J4
        • Pfizer Investigational Site
      • Edmonton, Alberta, Kanada, T6G 2B7
        • Pfizer Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Kanada, V5Z 1M9
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Kanada, N6A 4G5
        • Pfizer Investigational Site
      • Toronto, Ontario, Kanada, M5G 2C4
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Kanada, H3T 1E2
        • Pfizer Investigational Site
  • Mexiko
    • CP
      • Monterrey, CP, Mexiko, 64020
        • Pfizer Investigational Site
    • DF
      • Tlalpan, DF, Mexiko, 14080
        • Pfizer Investigational Site
    • N.l.
      • Monterrey, N.l., Mexiko, 64360
        • Pfizer Investigational Site
  • Nederländerna
      • Amsterdam, Nederländerna, 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
  • Spanien
      • Barcelona, Spanien, 08036
        • Pfizer Investigational Site
  • Storbritannien
      • Glasgow, Storbritannien, G11 6NT
        • Pfizer Investigational Site
      • London, Storbritannien, NW3 2QG
        • Pfizer Investigational Site
      • Newcastle, Storbritannien, NE7 7DN
        • Pfizer Investigational Site
    • Cambridgeshire
      • Papworth Everard, Cambridgeshire, Storbritannien, 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
  • Österrike
      • Graz, Österrike, 8036
        • Pfizer Investigational Site
      • Wien, Österrike, 1090
        • Pfizer Investigational Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år till 75 år (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Sitaxsentan
Läkemedel: Sitaxsentan
Sitaxsentan 100 mg tablets once daily
Andra namn:
  • Sitaxentan

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2003

Primärt slutförande (Faktisk)

1 juli 2011

Avslutad studie (Faktisk)

1 juli 2011

Studieregistreringsdatum

Först inskickad

9 december 2008

Först inskickad som uppfyllde QC-kriterierna

16 december 2008

Första postat (Uppskatta)

18 december 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

24 april 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 mars 2012

Senast verifierad

1 november 2011

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • B1321007
  • FPH03

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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