Effects of Oral Sildenafil on Mortality in Adults With PAH
- Registration Number
- NCT02060487
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 385
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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dose sildenafil citrate - High dose sildenafil citrate - Medium dose sildenafil citrate -
- Primary Outcome Measures
Name Time Method Overall Survival Day 1 of study treatment up to date of death (within a maximum duration of 2102 days) In this outcome measure number of deaths during the study were reported.
- Secondary Outcome Measures
Name Time Method Number of Participants With Clinical Worsening Events Day 1 of study treatment up to date of clinical worsening event (within a maximum duration of 2080 days) Clinical worsening was defined as all-cause mortality, non-elective hospital stay for worsening pulmonary arterial hypertension (PAH) (including but not limited to right heart failure \[RHF\], initiation of intravenous (IV) prostanoids, lung transplantation, or septostomy) or disease progression. Disease progression was defined as a reduction from baseline in the 6-Minute Walk Distance (6MWD) test by 15% and worsening functional class from baseline, both confirmed by second test within 2 weeks of study treatment.
Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6 Baseline, Month 6 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Analysis was performed using mixed model for repeated measures (MMRM), adjusted for baseline 6MWD and for randomization stratification factors: PAH treatment at study entry and etiology of PAH.
Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 12 Baseline, Month 12 6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Analysis was performed using mixed model for repeated measures (MMRM), adjusted for baseline 6MWD and for randomization stratification factors: PAH treatment at study entry and etiology of PAH.
Related Research Topics
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Trial Locations
- Locations (80)
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
University Hospital of Mont-Godinne
🇧🇪Yvoir, Belgium
FSBI Scientific Research Institute of Pulmonology of FMBA
🇷🇺Moscow, Russian Federation
Universitaetsmedizin Greifswald
🇩🇪Greifswald, Germany
FSBI "E.Meshalkin National medical research center"
🇷🇺Novosibirsk, Russian Federation
FSBI "V.A. Almazov National Medical Research Center"
🇷🇺St. Petersburg, Russian Federation
Health Institution Special Hospital "Medical Institute Bayer"
🇧🇦Tuzla, Canton Tuzla, Bosnia and Herzegovina
Spectrum Health Heart & Lung Specialized Care Clinic
🇺🇸Grand Rapids, Michigan, United States
Robert V. Sibilia MD, Inc.
🇺🇸Wooster, Ohio, United States
Dr PG Williams Practice
🇿🇦Johannesburg, Gauteng, South Africa
UT Southwestern Medical School
🇺🇸Dallas, Texas, United States
Clinical Center University Sarajevo
🇧🇦Sarajevo, Bosnia AND Herzegovina/canton Sarajevo, Bosnia and Herzegovina
Centro de Desarrollo Biomedico
🇲🇽Merida, Yucatan, Mexico
Institutul Inimii ,,Niculae Stancioiu" Cluj Napoca
🇷🇴Cluj-Napoca, Romania
Universitaetsklinikum Schleswig-Holstein
🇩🇪Luebeck, Germany
Institut Klinicke a Experimentalni Mediciny
🇨🇿Praha 4, Czechia
Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Spectrum Health Butterworth Hospital IDS Pharmacy
🇺🇸Grand Rapids, Michigan, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitatsklinikum TU Dresden
🇩🇪Dresden, Germany
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
Universitaetsklinikum der TU Dresden
🇩🇪Dresden, Germany
Dokuz Eylul Üniversitesi Tıp Fakültesi Kardiyoloji Bilim Dalı
🇹🇷Izmir, Inciralti, Turkey
The Chaim Sheba Medical Center
🇮🇱Tel-Hashomer, Israel
University Hospital Center Zagreb
🇭🇷Zagreb, Croatia
University Hospital Dubrava
🇭🇷Zagreb, Croatia
DRK Kliniken Berlin, Westend
🇩🇪Berlin, Germany
Faculty of Medicine, Chulalongkorn University
🇹🇭Pathumwan, Bangkok, Thailand
Hospital Sultanah Aminah
🇲🇾Johor Bahru, Johor, Malaysia
King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University
🇹🇭Pathumwan, Bangkok, Thailand
Queen Sirikit Heart Center of the Northeast, Khon Kaen University
🇹🇭Muang District, Khon Kaen, Thailand
Division of Cardiology, Department of Medicine, Faculty of Medicine, Khon Kaen University
🇹🇭Muang District, Khon Kaen, Thailand
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
🇹🇭Muang District, Khon Kaen, Thailand
Emory University Investigational Drug Services
🇺🇸Atlanta, Georgia, United States
Frederik Meijer Heart & Vascular Institute Cardiovascular Research
🇺🇸Grand Rapids, Michigan, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Spectrum Health Medical Group - Pulmonary Division
🇺🇸Grand Rapids, Michigan, United States
St. Vincent's Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Australian Respiratory and Sleep Medicine Institute
🇦🇺Bedford Park, South Australia, Australia
Royal Brisbane & Women's Hospital
🇦🇺Herston, Queensland, Australia
Thoraxklinik am Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czech Republic, Czechia
University General Hospital of Patras
🇬🇷Patras, Greece
Hospital Sultanah Bahiyah
🇲🇾Alor Setar, Kedah, Malaysia
FSBI "Research Institute of complex problems of cardiovascular diseases"
🇷🇺Kemerovo, Russian Federation
Institute for Cardiovascular disease of Vojvodina
🇷🇸Sremska Kamenica, Vojvodina, Serbia
University Medical Center Zvezdara
🇷🇸Belgrade, Serbia
National University Heart Centre, National University Hospital Singapore (NUHS)
🇸🇬Singapore, Singapore
Center of Chest Diseases
🇿🇦Johannesburg, Gauteng, South Africa
Hospital Universitario Vall d´Hebrón
🇪🇸Barcelona, Cataluña, Spain
Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University
🇹🇭Sripoom Sub-district, Muang, Chiang MAI, Thailand
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
🇹🇷Istanbul, Bakirkoy, Turkey
Istanbul University Haseki Cardiology Institute
🇹🇷Istanbul, Fatih, Turkey
Istanbul University Cerrahpasa Medical Faculty
🇹🇷Istanbul, Fatih, Turkey
Komunalne nekomertsiine pidpryiemstvo
🇺🇦Uzhhorod,, Ukraine
Marmara University Pendik Training and Research Hospital
🇹🇷Istanbul, Pendik, Turkey
Komunalne nekomertsiine pidpryiemstvo Oleksandrivska klinichna likarnia m. Kyieva
🇺🇦Kyiv, Ukraine
Derzhavna ustanova Natsionalnyi naukovyi tsentr
🇺🇦Kyiv, Ukraine
Komunalne pidpryiemstvo "Dnipropetrovskyi oblasnyi klinichnyi tsentr kardiolohii ta kardiokhirurhii"
🇺🇦M. Dnipro, Ukraine
Spectrum Health Hospitals
🇺🇸Grand Rapids, Michigan, United States
Centro de Estudios Clinicos de Queretaro S.C.
🇲🇽Queretaro, Mexico
Hospital Serdang
🇲🇾Kajang, Selangor, Malaysia
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
University Clinical Center of the Republic of Srpska
🇧🇦Banja Luka, B&h/republic OF Srpska, Bosnia and Herzegovina
University General Hospital of Alexandroupolis
🇬🇷Alexandroupolis, Evros, Greece
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
University General Hospital of Thessaloniki AHEPA
🇬🇷Thessaloniki, Greece
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
Samodzielny Publiczny Szpital Kliniczny nr 4
🇵🇱Lublin, Poland
Maharaj Nakorn Chiang Mai Hospital
🇹🇭Muang, Chiang MAI, Thailand
University Clinical Hospital Mostar
🇧🇦Mostar, Herzegovina-neretva Canton, Bosnia and Herzegovina
Institutul de Urgenta pentru Boli Cardiovasculare si Transplant Targu-Mures
🇷🇴Targu-Mures, Romania
University General Hospital of Athens "Attikon"
🇬🇷Athens, Attiki, Greece
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Institute for Pulmonary Diseases of Vojvodina
🇷🇸Sremska Kamenica, Vojvodina, Serbia
Khoo Teck Puat Hospital
🇸🇬Singapore, Singapore
Centro De Prevencion Y Rehabilitacion De Enfermedades Pulmonares Crónicas
🇲🇽Monterrey, Nuevo LEÓN, Mexico
Prince of Wales Hospital
🇭🇰Shatin, New Territories, Hong Kong