To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
NCT ID: NCT00430716
Last Updated: 2020-12-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
130 participants
INTERVENTIONAL
2008-04-08
2010-05-25
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
TRIPLE
Study Groups
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Sildenafil High dose
Sildenafil citrate
oral, 20 mg, tid
Sildenafil Low dose
Sildenafil citrate
oral 1 mg, tid
Sildenafil medium dose
Sildenafil citrate
oral 5 mg, tid
Sildenafil - Open label Phase
Open label extension from week 12 to week 24.
Sildenafil citrate
oral 20 mg, tid
Interventions
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Sildenafil citrate
oral, 20 mg, tid
Sildenafil citrate
oral 1 mg, tid
Sildenafil citrate
oral 5 mg, tid
Sildenafil citrate
oral 20 mg, tid
Eligibility Criteria
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Inclusion Criteria
* Subjects with a mean pulmonary artery pressure of \>/= 25 mmHg and a pulmonary artery wedge pressure of \</= 15 mmHg at rest via right heart catheterization performed within 12 weeks prior to randomization.
Exclusion Criteria
* Subjects who are currently receiving any forms of chronic treatment for PAH such as prostacyclin, PDE-5 inhibitors, endothelin-receptor antagonists, nitrates or nitric oxide donors (e.g. arginine supplement, nicorandil) in any form, protease inhibitors such as ritonavir and saquinavir, ketoconazole, itraconazole, and alpha blockers. Subjects previously receiving any of these drugs must have stopped use for a period of at least 1 month prior to screening, except in the case of bosentan or prostacyclin (3 months).
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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Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, United States
Medical College of Georgia
Augusta, Georgia, United States
Atlanta Institute for Medical Research, Inc.
Decatur, Georgia, United States
Chicago Heart Institute
Elk Grove Village, Illinois, United States
The Care Group, LLC
Indianapolis, Indiana, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Mid Carolina Cardiology
Charlotte, North Carolina, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
Baylor College of Medicine Pulmonary Section
Houston, Texas, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
University of Utah Sciences Center
Salt Lake City, Utah, United States
CJW Chippenham Medical Center
Richmond, Virginia, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, United States
Cardiovascular Associates of Virginia
Richmond, Virginia, United States
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, Brazil
Peta mnogoprofilna bolnitsa za aktivno lechenie, Klinika po kardiologia
Sofia, , Bulgaria
Mnogoprofilna bolnitsa za aktivno lechenie i speshna meditsina "N.I.Pirogov"
Sofia, , Bulgaria
Beijing Shijitan Hospital
Beijing, , China
Shanghai Pulmonology Hospital
Shanghai, , China
Attikon Hospital
Haidari, Athens, Greece
Care Hospital, The Institute of Medical Sciences
Hyderabad, Andhra Pradesh, India
Mehta Hospital & Cardiopulmonary Care Center
Ahmedabad, Gujarat, India
Bankers Heart Institute
Vadodara, Gujarat, India
St. John's Medical College Hospital
Bangalore, Karnataka, India
Metro Multispeciality Hospital
Noida, Uttar Pradesh, India
IRCCS Policlinico San Matteo
Pavia, , Italy
Unita' di Ipertensione Polmonare, Dipartimento di Scienze Respiratorie e Cardiovascolari
Roma, , Italy
P. Stradins Clinical University Hospital / Latvian Centre of Cardilogy
Riga, , Latvia
National Heart Institute
Kuala Lumpur, , Malaysia
VU Medisch Centrum / afdeling Longziekten
Amsterdam, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Philippine General Hospital
Manila, , Philippines
Philippine Heart Center
Quezon City, , Philippines
Krakowski Szpital Specjalistyczny Im. Jana Pawla II w Krakowie
Krakow, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Slaskie Centrum Chorob Serca
Zabrze, , Poland
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes
Timișoara, Timiș County, Romania
Spitalul Clinic de Pneumoftiziologie
Iași, , Romania
Scientific Center of Cardiovascular surgery n.a. A.N.Bakoulev RAMS
Moscow, , Russia
Scientific Center of Cardiovascular surgery n.a. A.N.Bakoulev RAMS
Moscow, , Russia
Division of Rheumatology Allergy and Immunology, Department of Medicine, Faculty of Medicine
Amphoe Mueang, Changwat Khon Kaen, Thailand
Department of Medicine,
Bangkok, , Thailand
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Room 224A Sir William Leech Centre
Newcastle upon Tyne, TYNE and WEAR, United Kingdom
Countries
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References
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Vizza CD, Sastry BK, Safdar Z, Harnisch L, Gao X, Zhang M, Lamba M, Jing ZC. Efficacy of 1, 5, and 20 mg oral sildenafil in the treatment of adults with pulmonary arterial hypertension: a randomized, double-blind study with open-label extension. BMC Pulm Med. 2017 Feb 23;17(1):44. doi: 10.1186/s12890-017-0374-x.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2006-006748-76
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A1481244
Identifier Type: -
Identifier Source: org_study_id