Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension
NCT ID: NCT00454207
Last Updated: 2021-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
44 participants
INTERVENTIONAL
2007-04-30
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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sildenafil citrate (UK-92,480)
sildenafil citrate 20 mg TID
sildenafil citrate (UK-92,480)
sildenafil citrate (UK-92,480)
Interventions
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sildenafil citrate (UK-92,480)
sildenafil citrate (UK-92,480)
Eligibility Criteria
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Inclusion Criteria
* Subjects who meet the following conditions on right heart catheterization at screening or baseline: mean pulmonary arterial pressure of ≥ 25mmHg and pulmonary capillary wedge pressure of ≤ 15mmHg at rest
* Subjects whose baseline 6-Minute Walk test distance is \>100 m and \<450 m
Exclusion Criteria
* Subjects with known hereditary degenerative retinal disorders (such as retinitis pigmentosa) or history of non-arteritic ischemic optic neuropathy (NAION)
* Subjects who are currently receiving nitrates or nitric oxide donors in any form, ritonavir, ketoconazole and itraconazole
16 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
Chiba, Chiba, Japan
Pfizer Investigational Site
Kanazawa, Ishikawa-ken, Japan
Pfizer Investigational Site
Tsu, Mie-ken, Japan
Pfizer Investigational Site
Okayama, Okayama-ken, Japan
Pfizer Investigational Site
Hamamatsu, Shizuoka, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Pfizer Investigational Site
Tokyo, , Japan
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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JapicCTI-070381
Identifier Type: -
Identifier Source: secondary_id
A1481252
Identifier Type: -
Identifier Source: org_study_id
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