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Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Chiba-shi, Chiba, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Subjects aged 16 and over, and classified as having pulmonary arterial hypertension

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Significant Hepatic and/or renal disorder

- 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

NCT00454207
Pfizer
Completed
Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

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[email protected]

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