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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 marzo 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Open-label extension

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1192

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Austria
      • Graz, Austria, 8036
        • Pfizer Investigational Site
      • Wien, Austria, 1090
        • Pfizer Investigational Site
  • Belgio
      • Bruxelles, Belgio, 1070
        • Pfizer Investigational Site
      • Leuven, Belgio, B - 3000
        • Pfizer Investigational Site
  • Brasile
      • Sao Paulo, Brasile, 05403-000
        • Pfizer Investigational Site
    • MG
      • Belo Horizonte, MG, Brasile, 30380-090
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brasile, 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
  • Francia
      • Clamart Cedex, Francia, 92141
        • Pfizer Investigational Site
      • GRENOBLE Cedex 09, Francia, 38043
        • Pfizer Investigational Site
      • Strasbourg, Francia, 67098
        • Pfizer Investigational Site
  • Germania
      • Berlin, Germania, 14050
        • Pfizer Investigational Site
      • Dresden, Germania, 01307
        • Pfizer Investigational Site
      • Giessen, Germania, 35392
        • Pfizer Investigational Site
      • Greifswald, Germania, 17487
        • Pfizer Investigational Site
      • Hannover, Germania, 30625
        • Pfizer Investigational Site
      • Heidelberg, Germania, 69120
        • Pfizer Investigational Site
      • Leipzig, Germania, 04103
        • Pfizer Investigational Site
      • Regensburg, Germania, 93053
        • Pfizer Investigational Site
  • Israele
      • Petach Tikva, Israele, 49100
        • Pfizer Investigational Site
      • Tel-Hashomer, Ramat Gan, Israele, 52601
        • Pfizer Investigational Site
  • Italia
      • Bologna, Italia, 40138
        • Pfizer Investigational Site
  • Messico
    • CP
      • Monterrey, CP, Messico, 64020
        • Pfizer Investigational Site
    • DF
      • Tlalpan, DF, Messico, 14080
        • Pfizer Investigational Site
    • N.l.
      • Monterrey, N.l., Messico, 64360
        • Pfizer Investigational Site
  • Olanda
      • Amsterdam, Olanda, 1081 HV
        • Pfizer Investigational Site
  • Polonia
      • Krakow, Polonia, 31-202
        • Pfizer Investigational Site
      • Warszawa, Polonia, 01-138
        • Pfizer Investigational Site
      • Zabrze, Polonia, 41-800
        • Pfizer Investigational Site
  • Regno Unito
      • Glasgow, Regno Unito, G11 6NT
        • Pfizer Investigational Site
      • London, Regno Unito, NW3 2QG
        • Pfizer Investigational Site
      • Newcastle, Regno Unito, NE7 7DN
        • Pfizer Investigational Site
    • Cambridgeshire
      • Papworth Everard, Cambridgeshire, Regno Unito, CB3 8RB
        • Pfizer Investigational Site
  • Spagna
      • Barcelona, Spagna, 08036
        • Pfizer Investigational Site
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, Stati Uniti, 35294
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85013
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, Stati Uniti, 90073
        • Pfizer Investigational Site
      • San Francisco, California, Stati Uniti, 94143-0124
        • Pfizer Investigational Site
      • Torrence, California, Stati Uniti, 90502
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, Stati Uniti, 80262
        • Pfizer Investigational Site
      • Denver, Colorado, Stati Uniti, 80218
        • Pfizer Investigational Site
    • Florida
      • Sarasota, Florida, Stati Uniti, 34233
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Pfizer Investigational Site
      • Augusta, Georgia, Stati Uniti, 30912
        • Pfizer Investigational Site
      • Decatur, Georgia, Stati Uniti, 30033
        • Pfizer Investigational Site
      • Decatur, Georgia, Stati Uniti, 30030
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, Stati Uniti, 66160
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40536
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Stati Uniti, 70112
        • Pfizer Investigational Site
      • New Orleans, Louisiana, Stati Uniti, 70112-1393
        • Pfizer Investigational Site
    • Maine
      • Portland, Maine, Stati Uniti, 04102
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21205
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02118
        • Pfizer Investigational Site
      • Boston, Massachusetts, Stati Uniti, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, Stati Uniti, 02111
        • Pfizer Investigational Site
      • Boston, Massachusetts, Stati Uniti, 02218
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109-0570
        • Pfizer Investigational Site
      • Detroit, Michigan, Stati Uniti, 48201
        • Pfizer Investigational Site
    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, Stati Uniti, 08903-0019
        • Pfizer Investigational Site
    • New York
      • New York, New York, Stati Uniti, 10032
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27710
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44106
        • Pfizer Investigational Site
      • Cleveland, Ohio, Stati Uniti, 44195
        • Pfizer Investigational Site
      • Columbus, Ohio, Stati Uniti, 43210
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19140
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37232
        • Pfizer Investigational Site
      • Nashville, Tennessee, Stati Uniti, 37232-5735
        • Pfizer Investigational Site
      • Nashville, Tennessee, Stati Uniti, 37232-2650
        • Pfizer Investigational Site
    • Texas
      • Galveston, Texas, Stati Uniti, 77555-0561
        • Pfizer Investigational Site
      • Houston, Texas, Stati Uniti, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, Stati Uniti, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84143
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Pfizer Investigational Site
      • Milwaukee, Wisconsin, Stati Uniti, 53215
        • Pfizer Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 75 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Sitaxsentan
Droga: Sitaxsentan
Sitaxsentan 100 mg tablets once daily
Altri nomi:
  • Sitaxentan

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2003

Completamento primario (Effettivo)

1 luglio 2011

Completamento dello studio (Effettivo)

1 luglio 2011

Date di iscrizione allo studio

Primo inviato

9 dicembre 2008

Primo inviato che soddisfa i criteri di controllo qualità

16 dicembre 2008

Primo Inserito (Stima)

18 dicembre 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

24 aprile 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 marzo 2012

Ultimo verificato

1 novembre 2011

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • B1321007
  • FPH03

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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