Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil
NCT ID: NCT00796666
Last Updated: 2015-03-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
131 participants
INTERVENTIONAL
2009-05-31
2011-03-31
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
DOUBLE
Study Groups
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Sitaxsentan and Placebo
Monotherapy arm
Sitaxsentan
Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day
Sitaxsentan and Sildenafil
Combination treatment
Sitaxsentan and Sildenafil
Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day
Interventions
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Sitaxsentan
Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day
Sitaxsentan and Sildenafil
Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
80 Years
ALL
No
Sponsors
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Pfizer
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
Fountain Valley, California, United States
Pfizer Investigational Site
Gainesville, Florida, United States
Pfizer Investigational Site
Weston, Florida, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
Chapel Hill, North Carolina, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Providence, Rhode Island, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Milwaukee, Wisconsin, United States
Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
Sofia, , Bulgaria
Pfizer Investigational Site
Temuco, , Chile
Pfizer Investigational Site
Changsha, Hunan, China
Pfizer Investigational Site
Beijing, , China
Pfizer Investigational Site
Shanghai, , China
Pfizer Investigational Site
Shanghai, , China
Pfizer Investigational Site
Bogotá, Cundinamarca, Colombia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India
Pfizer Investigational Site
Ahmedabad, Gujarat, India
Pfizer Investigational Site
Ahmedabad, Gujarat, India
Pfizer Investigational Site
Surat, Gujarat, India
Pfizer Investigational Site
Vadodara, Gujarat, India
Pfizer Investigational Site
Pune, Maharashtra, India
Pfizer Investigational Site
Coimbatore, Tamil Nadu, India
Pfizer Investigational Site
Madurai, Tamil Nadu, India
Pfizer Investigational Site
George Town, Pulau Pinang, Malaysia
Pfizer Investigational Site
Monterrey, Nuevo León, Mexico
Pfizer Investigational Site
Lima, , Peru
Pfizer Investigational Site
Cluj-Napoca, Romania, Romania
Pfizer Investigational Site
Iași, , Romania
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Saint Petersburg, , Russia
Pfizer Investigational Site
Belgrade, , Serbia
Pfizer Investigational Site
Johannesburg, , South Africa
Pfizer Investigational Site
Bangkoknoi, Bangkok, Thailand
Pfizer Investigational Site
Istanbul, Fatih, , Turkey (Türkiye)
Pfizer Investigational Site
Kyiv, , Ukraine
Pfizer Investigational Site
Kyiv, , Ukraine
Countries
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Related Links
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Other Identifiers
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B1321003
Identifier Type: -
Identifier Source: org_study_id
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