Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension
NCT ID: NCT00323297
Last Updated: 2021-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
105 participants
INTERVENTIONAL
2006-09-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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placebo
Bosentan
Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
Placebo
Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
Active
Bosentan
Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
Sildenafil Citrate
Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
Interventions
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Bosentan
Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
Placebo
Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
Bosentan
Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
Sildenafil Citrate
Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
Eligibility Criteria
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Inclusion Criteria
* Subjects with a mean pulmonary artery pressure of \>25mmHg and a pulmonary artery wedge pressure of \<15mmHg at rest via right heart catheterization within 3 years prior to randomization.
* Subjects whose baseline 6 Minute Walk Test distance is \>100m and \< 450m.
* Subjects whose 6 Minute Walk Test may be limited by conditions other than PAH related dyspnoea or fatigue eg. claudication from vascular insufficiency or arthritis.
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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West Los Angeles VA Healthcare, Pulmonary Hypertension Program
Los Angeles, California, United States
Henry Ford Hospital
Detroit, Michigan, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
St. Vincents Hospital
Darlinghurst, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Institut klinicke a experimentalni mediciny, Klinika kardiologie
Prague, , Czechia
Clinique des Maladies Respiratoires
Lille, , France
Hopital Claude Huriez
Lille, , France
Hopital Adules Brabois
Vandœuvre-lès-Nancy, , France
Unfallkrankenhaus Berlin, Klinik fuer Innere Medizin
Berlin, , Germany
II. Medizinische Klinik, Kardiologie, Angiologie und Pneumologie
Coburg, , Germany
Universitaetsklinikum Essen, Zentrum fuer Innere Medizin, Klinik fuer Kardiologie
Essen, , Germany
Universitaetsklinikum Giessen und Marburg GmbH, Standort Giessen
Giessen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaetsklinikum des Saarlandes, Innere Medizin V
Homburg, , Germany
Medizinische Klinik und Poliklinik I, Universitaetsklinikum Leipzig
Leipzig, , Germany
Med. Klinik u. Poliklinik I der LMU Muenchen, Klinikum Grosshadern
München, , Germany
Praxis fuer Innere Medizin, Kardiologie und Angiologie
Nuremberg, , Germany
Missionsaerztliche Klinik Wuerzburg, Gemeinnuetzige Gesellschaft mbH
Würzburg, , Germany
Attikon Hospital
Haidari, Athens, Greece
Rambam Medical Center
Haifa, , Israel
Rabin Medical Centre
Petah Tikva, , Israel
Cardiologia, Azienda Ospedaliera Monaldi, Seconda Università di Napoli
Napoli, , Italy
Unita' di Ipertensione Polmonare, Dipartimento di Scienze Respiratorie e Cardiovascolari
Roma, , Italy
Department of Surgery, National Taiwan University Hospital
Taipei, , Taiwan
PVDU
Papworth Everard, Cambridgeshire, United Kingdom
Countries
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References
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Vizza CD, Jansa P, Teal S, Dombi T, Zhou D. Sildenafil dosed concomitantly with bosentan for adult pulmonary arterial hypertension in a randomized controlled trial. BMC Cardiovasc Disord. 2017 Sep 6;17(1):239. doi: 10.1186/s12872-017-0674-3.
Other Identifiers
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2006-001464-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PATHWAYS
Identifier Type: OTHER
Identifier Source: secondary_id
A1481243
Identifier Type: -
Identifier Source: org_study_id
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