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Effects of oral sildenafil on mortality in adults with PAH

Sponsored by Pfizer

Phase Quota
Phase 4

This is a blinded study in adult patients with PAH evaluating the relative effects of sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three times per day [TID]). In addition, the relative effects on clinical worsening and 6-minute walking distance (6MWD) will be assessed.

Study Start Date: September 2014

Estimated Completion Date: June 2022

Specialties: Internal Medicine: Epidemiology Family Medicine: Epidemiology

Interventions

  • Drug: sildenafil citrate

Inclusion criteria

  • Subjects  18 <75 years of age with any of the following conditions:
  • Idiopathic Primary Pulmonary Arterial Hypertension (IPAH)
  • PAH secondary to connective tissue disease
  • PAH with surgical repair (at least 5 years previously) of atrial septal defect (ASD),ventricular septal defect (VSD), patent ductus arteriosus (PDA) and aorto-pulmonary window
  • PAH diagnosis confirmed by right heart catheterization performed within 12 months prior to randomization
  • Functional Class II-IV; Baseline 6MWD  50 m

Exclusion criteria

  • Significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation
  • History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation
  • History of pulmonary embolism; History of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with impairment of lung function
  • No prior long term treatment with PDE-5 inhibitors
  • Treatment with bosentan OR riociguat within 3 months of randomization
  • Current treatment with nitrates or nitric oxide

Study Locations And Contact Information

  • Zakarpatskyi oblasnyi klinichnyi kardiolohichnyi dyspanser infarktne viddilennia m Uzhhorod, Uzhhorod
  • Emory University Investigational Drug Services, Atlanta Georgia
  • Universitaetsklinikum HamburgEppendorf UKE, Hamburg
  • Aurora St Lukes Medical Center, Milwaukee Wisconsin
  • Hospital Universitario La Paz, Madrid
  • University Hospital Dubrava, Zagreb
  • Derzhavna ustanova Natsionalnyi naukovyi tsentr Instytut kardiolohii, Kyiv
  • Samodzielny Publiczny Szpital Kliniczny nr 4, Lublin
  • Universitaetsklinikum Leipzig, Leipzig
  • Komunalnyi zaklad Dnipropetrovskyi oblasnyi klinichnyi tsentr kardiolohii ta kardiokhirurhii, Dnipropetrovsk
  • Vseobecna fakultni nemocnice v Praze, Praha 2
  • University Hospital Center Zagreb, Zagreb
  • Spectrum Health Butterworth Hospital IDS Pharmacy, Grand Rapids Michigan
  • Zentralklinik Bad Berka GmbH, Bad Berka Thüringen
  • Institute for Treatment and Rehabilitation Niska Banja, Niska Banja Nisava/serbia
  • Institutional Review Board Faculty of Medicine Chulalongkorn University, Pathumwan Bangkok
  • Division of Cardiology Department of Internal Medicine Faculty of Medicine Chiang Mai University, Sripoom Sub-district, Muang Chiang Mai
  • Australian Respiratory and Sleep Medicine Institute, Bedford Park South Australia
  • University Clinical Center of the Republic of Srpska, Banja Luka B&h/republic of Srpska
  • University Hospital of TU Dresden, Dresden Sachsen
  • Spectrum Health Richard DeVos Heart Lung Transplant Clinic, Grand Rapids Michigan
  • Hospital Universitario Arnau de Vilanova, Lleida Cataluña
  • University Medical Center Zvezdara, Belgrade
  • Robert V Sibilia MD Inc, Wooster Ohio
  • Universitaetsmedizin Greifswald, Greifswald
  • St Vincents Hospital, Darlinghurst New South Wales
  • Cleveland Clinic, Cleveland Ohio
  • FSBI Novosibirsk Scientific Research Institute of blood circulation pathology na Meshalkin, Novosibirsk
  • Consultmed SRL, Iasi
  • The Emory Clinic, Atlanta Georgia
  • BH Heart Center Tuzla, Tuzla B&h/canton Tuzla
  • Abbott Northwestern Hospital, Minneapolis Minnesota
  • St Antonius Ziekenhuis Locatie Nieuwegein, Nieuwegein Utrecht
  • National University Heart Centre National University Hospital Singapore NUHS, Singapore
  • Hospital Garcia de Orta EPE, Almada Setubal
  • Minneapolis Heart Institute Foundation, Minneapolis Minnesota
  • Department of Cardiology, Soweto Gauteng
  • Komunalnyi zaklad okhorony zdorovia, Kharkiv
  • Spectrum Health Office of Research Administration, Grand Rapids Michigan
  • University General Hospital Attikon, Haidari, Athens Attiki
  • Hospital Universitario 12 de Octubre, Madrid Madrid/spain
  • Institutul de Urgenta pentru Boli Cardiovasculare si Transplant TarguMures, Targu-Mures
  • Spectrum Health Medical Group Pulmonary Division, Grand Rapids Michigan
  • Shaare Zedek Medical Center, Jerusalem
  • University Clinical Hospital Mostar, Mostar Herzegovina-neretva Canton
  • Krankenhaus der Elisabethinen LinZ GmbH, Linz
  • Centro De Prevencion Y Rehabilitacion De Enfermedades Pulmonares Crnicas, Monterrey Nuevo León
  • Institute for Pulmonary Diseases of Vojvodina, Sremska Kamenica Vojvodina/serbia
  • Spectrum Health Medical Center, Grand Rapids Michigan
  • University General Hospital of Heraklion, Heraklion Crete
  • The Barzilai Medical Center, Ashkelon
  • Institute for Cardiovascular disease of Vojvodina, Sremska Kamenica Vojvodina
  • Division of Cardiology Department of Medicine Faculty of Medicine Khon Kaen University, Muang District Khon Kaen , Thailand
  • UT Southwestern Medical Center, Dallas Texas
  • Almazov Federal NorthWest Medical Research Centre, St. Petersburg Russia
  • Unidad Mdica para la Salud Integral UMSI, San Nicolás de Los Garza Nuevo León
  • Khoo Teck Puat Hospital, Singapore
  • Angiocardiac Care of Texas PA, Houston Texas
  • Centro de Desarrollo Biomdico, Merida Yucatan
  • University Hospital of MontGodinne, Yvoir
  • Changi General Hospital, Singapore
  • University General Hospital of Patras, Rion Patras Patras
  • Centralny Szpital Kliniczny MSW w Warszawie, Warsaw
  • UC Davis Medical Center, Sacramento California
  • Clinical Center Kragujevac, Kragujevac
  • Oleksandrivska klinichna likarnia m Kyieva, Kyiv
  • Clinical Center of Serbia, Belgrade
  • Sultanah Aminah Hospital, Johor Bahru Johor
  • FSBI Scientific Research Institute of Pulmonology of FMBA, Moscow
  • Westmead Hospital, Westmead New South Wales
  • Kyivska miska klinichna likamia No 5 kardiolohichne viddilennia, Kyiv
  • Pulmonary institute Rabin Medical Center Beilinson Hospital, Petah Tikva
  • The Chaim Sheba Medical Center, Tel-Hashomer
  • Fakultni nemocnice Olomouc, Olomouc
  • Royal Brisbane Womens Hospital, Herston Queensland
  • University Malaya Medical Centre, Kuala Lumpur
  • Hospital Universitario Val dHebrn, Barcelona Cataluña
  • Frederik Meijer Heart Vascular Institute Cardiovascular Research, Grand Rapids Michigan
  • Hospitais da Universidade de Coimbra, Coimbra
  • Hospital Universitario Dr Peset, Valencia
  • Institut klinicke a experimentalni mediciny, Praha 4
  • Universitair Ziekenhuis Gent, Gent
  • Kaplan Medical Center, Rehovot
  • FSBI Research Institute of complex problems of cardiovascular diseases, Kemerovo Russia
  • Institutul Inimii Niculae Stancioiu Cluj Napoca, Cluj-Napoca
  • PDS Research, Kissimmee Florida
  • Center of Chest Diseases Research Unit, Johannesburg Gauteng
  • AHEPA University General Hospital of Thessaloniki, Thessaloniki
  • Federal State Budgetary Scientific Institution Research Institute for ardiology, Tomsk
  • University General Hospital of Alexandroupolis, Alexandroupolis Evros

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