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
NCT ID: NCT00644605
Last Updated: 2021-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
275 participants
INTERVENTIONAL
2002-10-31
2003-11-30
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
DOUBLE
Study Groups
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Arm 1
sildenafil
sildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
Arm 2
sildenafil
sildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
Arm 3
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
Arm 4
placebo
placebo by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
Interventions
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sildenafil
sildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
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
placebo
placebo by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
sildenafil
sildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
Eligibility Criteria
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Inclusion Criteria
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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Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
La Jolla, California, United States
Pfizer Investigational Site
La Jolla, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Torrance, California, United States
Pfizer Investigational Site
Torrance, California, United States
Pfizer Investigational Site
Aurora, Colorado, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Ann Arbor, Michigan, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Nashville, Tennessee, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Milwaukee, Wisconsin, United States
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia
Pfizer Investigational Site
Melbourne, Victoria, Australia
Pfizer Investigational Site
Brussels, , Belgium
Pfizer Investigational Site
Leuven, , Belgium
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Copenhagen, , Denmark
Pfizer Investigational Site
Clamart, , France
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Giessen, , Germany
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Giessen, , Germany
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Hanover, , Germany
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Leipzig, , Germany
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Shatin N T, , Hong Kong
Pfizer Investigational Site
Budapest, Pest County, Hungary
Pfizer Investigational Site
Zalaegerszeg, Zala County, Hungary
Pfizer Investigational Site
Petah Tikva, , Israel
Pfizer Investigational Site
Tel Litwinsky, , Israel
Pfizer Investigational Site
Bologna, , Italy
Pfizer Investigational Site
Pisa, , Italy
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Pisa, , Italy
Pfizer Investigational Site
Kuala Lumpur, , Malaysia
Pfizer Investigational Site
Tlalpan, , Mexico
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Amsterdam, , Netherlands
Pfizer Investigational Site
Oslo, , Norway
Pfizer Investigational Site
Katowice, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Warsaw, , Poland
Pfizer Investigational Site
Zabrze, , Poland
Pfizer Investigational Site
Singapore, , Singapore
Pfizer Investigational Site
Cape Town, , South Africa
Pfizer Investigational Site
Johannesburg, , South Africa
Pfizer Investigational Site
Parow, , South Africa
Pfizer Investigational Site
Suwon, , South Korea
Pfizer Investigational Site
Barcelona, , Spain
Pfizer Investigational Site
Barcelona, , Spain
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Madrid, , Spain
Pfizer Investigational Site
Gothenburg, , Sweden
Pfizer Investigational Site
Mölndal, , Sweden
Pfizer Investigational Site
Papworth Everard, Cambridgeshire, United Kingdom
Pfizer Investigational Site
Sheffield, South Yorkshire, United Kingdom
Pfizer Investigational Site
Glasgow, , United Kingdom
Pfizer Investigational Site
HIGH Heaton, Newcastle-upon-tyne, , United Kingdom
Countries
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References
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Wirostko BM, Tressler C, Hwang LJ, Burgess G, Laties AM. Ocular safety of sildenafil citrate when administered chronically for pulmonary arterial hypertension: results from phase III, randomised, double masked, placebo controlled trial and open label extension. BMJ. 2012 Feb 21;344:e554. doi: 10.1136/bmj.e554.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A1481140
Identifier Type: -
Identifier Source: org_study_id
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