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A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension

28. januar 2021 opdateret af: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over

To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

275

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Australien
    • New South Wales
      • Darlinghurst, New South Wales, Australien, 2010
        • Pfizer Investigational Site
    • Victoria
      • Melbourne, Victoria, Australien, 3004
        • Pfizer Investigational Site
  • Belgien
      • Bruxelles, Belgien, 1070
        • Pfizer Investigational Site
      • Leuven, Belgien, 3000
        • Pfizer Investigational Site
  • Brasilien
    • SP
      • Sao Paulo, SP, Brasilien, 05403-900
        • Pfizer Investigational Site
  • Danmark
      • Kobenhavn, Danmark, 2100
        • Pfizer Investigational Site
  • Det Forenede Kongerige
      • Glasgow, Det Forenede Kongerige, G11 6NT
        • Pfizer Investigational Site
      • HIGH Heaton, Newcastle-upon-tyne, Det Forenede Kongerige, NE7 7DW
        • Pfizer Investigational Site
    • Cambridgeshire
      • Papworth Everard, Cambridgeshire, Det Forenede Kongerige, CB3 8RE
        • Pfizer Investigational Site
    • South Yorkshire
      • Sheffield, South Yorkshire, Det Forenede Kongerige, S10 2JF
        • Pfizer Investigational Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, Forenede Stater, 35294
        • Pfizer Investigational Site
      • Birmingham, Alabama, Forenede Stater, 35294-0006
        • Pfizer Investigational Site
    • California
      • La Jolla, California, Forenede Stater, 92037
        • Pfizer Investigational Site
      • La Jolla, California, Forenede Stater, 92093
        • Pfizer Investigational Site
      • Los Angeles, California, Forenede Stater, 90095
        • Pfizer Investigational Site
      • Los Angeles, California, Forenede Stater, 90033
        • Pfizer Investigational Site
      • Los Angeles, California, Forenede Stater, 90024
        • Pfizer Investigational Site
      • San Diego, California, Forenede Stater, 92037
        • Pfizer Investigational Site
      • Torrance, California, Forenede Stater, 90502
        • Pfizer Investigational Site
      • Torrance, California, Forenede Stater, 90509
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80010
        • Pfizer Investigational Site
      • Denver, Colorado, Forenede Stater, 80262
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, Forenede Stater, 71103
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Pfizer Investigational Site
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • 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
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Pfizer Investigational Site
  • Frankrig
      • Clamart, Frankrig, 92141
        • Pfizer Investigational Site
  • Holland
      • Amsterdam, Holland, 1081 HV
        • Pfizer Investigational Site
  • Hong Kong
      • Shatin N T, Hong Kong
        • Pfizer Investigational Site
  • Israel
      • Petach Tikva, Israel, 49100
        • Pfizer Investigational Site
      • Tel Hashomer, Israel, 52621
        • Pfizer Investigational Site
  • Italien
      • Bologna, Italien, 40138
        • Pfizer Investigational Site
      • Pisa, Italien, 56124
        • Pfizer Investigational Site
      • Pisa, Italien, 56126
        • Pfizer Investigational Site
  • Korea, Republikken
      • Suwon, Korea, Republikken, 442-721
        • Pfizer Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Pfizer Investigational Site
  • Mexico
      • Tlalpan, Mexico
        • Pfizer Investigational Site
  • Norge
      • Oslo, Norge, NO-0027
        • Pfizer Investigational Site
  • Polen
      • Katowice, Polen, 40-057
        • Pfizer Investigational Site
      • Warszawa, Polen, 01-138
        • Pfizer Investigational Site
      • Warszawa, Polen, 03-709
        • Pfizer Investigational Site
      • Zabrze, Polen, 41-800
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 168752
        • Pfizer Investigational Site
  • Spanien
      • Barcelona, Spanien, 08035
        • Pfizer Investigational Site
      • Barcelona, Spanien, 08036
        • Pfizer Investigational Site
      • Madrid, Spanien, 28041
        • Pfizer Investigational Site
  • Sverige
      • Goteborg, Sverige, 413 45
        • Pfizer Investigational Site
      • Molndal, Sverige, 431 80
        • Pfizer Investigational Site
  • Sydafrika
      • Cape Town, Sydafrika, 7700
        • Pfizer Investigational Site
      • Johannesburg, Sydafrika, 2193
        • Pfizer Investigational Site
      • Parow, Sydafrika
        • Pfizer Investigational Site
  • Tjekkiet
      • Prague 4, Tjekkiet, 140 00
        • Pfizer Investigational Site
      • Prague 4, Tjekkiet, 140 21
        • Pfizer Investigational Site
  • Tyskland
      • Berlin, Tyskland, 13353
        • Pfizer Investigational Site
      • Giessen, Tyskland, 35385
        • Pfizer Investigational Site
      • Giessen, Tyskland, 35392
        • Pfizer Investigational Site
      • Hannover, Tyskland, 30625
        • Pfizer Investigational Site
      • Leipzig, Tyskland, 04103
        • Pfizer Investigational Site
  • Ungarn
    • Pest
      • Budapest, Pest, Ungarn, 1529
        • Pfizer Investigational Site
    • Zala
      • Zalaegerszeg, Zala, Ungarn, 8900
        • 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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Included patients had primary pulmonary arterial hypertension, pulmonary hypertension secondary to connective tissue disease, or pulmonary hypertension with surgical repair at least 5 years previously; a mean pulmonary artery pressure greater than or equal to 25 mmHg and a pulmonary artery wedge pressure of less than or equal to 15 mmHg at rest, via right heart catheterisation within 21 days prior to randomisation; and a baseline 6-Minute Walk test distance of 100 m to 450 m.

Exclusion Criteria:

Subjects with congenital heart disease, pulmonary hypertension due to thromboembolism, HIV, chronic obstructive airway disease, congestive heart failure or schistosomiasis; subjects with significant (ie > 2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation; and acutely decompensated heart failure within the previous 30 days; subjects with pulmonary hypertension secondary to any other etiology other than those specified in the inclusion criteria.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm 2
Medicin: sildenafil
sildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
Medicin: sildenafil
sildenafil 80 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks; initially, patients received 40mg TID for one week and were then up-titrated to 80mg TID
Medicin: sildenafil
sildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
Aktiv komparator: Arm 1
Medicin: sildenafil
sildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
Medicin: sildenafil
sildenafil 80 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks; initially, patients received 40mg TID for one week and were then up-titrated to 80mg TID
Medicin: sildenafil
sildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
Placebo komparator: Arm 4
Medicin: placebo
placebo by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
Aktiv komparator: Arm 3
Medicin: sildenafil
sildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
Medicin: sildenafil
sildenafil 80 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks; initially, patients received 40mg TID for one week and were then up-titrated to 80mg TID
Medicin: sildenafil
sildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline in exercise capacity, as measured by distance walked in six minutes (6-Minute Walk test).
Tidsramme: Week 12
Week 12

Sekundære resultatmål

Resultatmål
Tidsramme
Change from baseline in mean pulmonary arterial pressure
Tidsramme: Week 12
Week 12
Time from randomisation to the first occurrence of clinical worsening (death or lung transplantation or hospitalisation due to pulmonary hypertension or initiation of prostacyclin therapy or initiation of bosentan therapy)
Tidsramme: Week 0 to 12
Week 0 to 12
Change from baseline in the BORG dyspnoea score
Tidsramme: Week 12
Week 12
Change from baseline in pulmonary hypertension criteria for functional capacity and therapeutic class
Tidsramme: Week 12
Week 12
Change from baseline in the 8 dimensions of SF-36 (Physical functioning, Role functioning, Bodily pain, General health, Vitality, Social functioning, Mental health and Reported health transition)
Tidsramme: Week 4 and Week 12
Week 4 and Week 12
Change from baseline at Weeks 4 and 12 in the 5 dimensions of ED5Q (Mobility, Self care, Usual Activities, Pain/Discomfort and Anxiety/Depression)
Tidsramme: Week 4 and Week 12
Week 4 and Week 12
Patient overall preference assessment
Tidsramme: Week 12
Week 12
Change in Chronic Use of Background Therapy for Pulmonary Arterial Hypertension
Tidsramme: throughout the study
throughout the study
Change from baseline in hemodynamic parameters
Tidsramme: Week 12
Week 12

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Generelle publikationer

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. oktober 2002

Studieafslutning (Faktiske)

1. november 2003

Datoer for studieregistrering

Først indsendt

20. marts 2008

Først indsendt, der opfyldte QC-kriterier

20. marts 2008

Først opslået (Skøn)

27. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A1481140

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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