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A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension

Last updated on March 14, 2019

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Study Location
Pulmonary Associates, PA
Phoenix, Arizona, 85006 United States
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
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Idiopathic or familial pulmonary arterial hypertension (PAH)

- Mean PAP at least 25 mm Hg, PCWP

- For females of child-bearing potential negative pregnancy test at screening and use of
contraception during the study and 4 weeks after its completion

- Signed and dated informed consent

- Willingness to comply with the study plan and procedures

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- pulmonary arterial hypertension (PAH)other than idiopathic or familial

- For females, pregnancy or lactation

- Use of specific PAH treatments, potent CYP3A4 inhibitors, protease inhibitors, alpha
blockers or arginine 30 days prior tio randomization and during the study

- Change of dose or class of standard background PAH therapy, i.e. oxygen, calcium
channel blockers, digoxin, diuretics 30 days prior tio randomization and during the
study

- Large shift in altitude (defined as >5000 feet or 1524 meters) during 90 days prior to
baseline visit and/or during the study visit

- Subjects with intracardiac shunts and/or serious heart, lung or other health
conditions

- HIV positive subjects

- Subjects participating in another clinical trial with an investigational drug or
device

- Subjects with degenerative retinal disorders, history of non-arteritic anterior
ischemic optic neuropathy or untreated proliferative diabetic retinopathy

- Allergies and previous intolerance of PDE5 inhibitors

- Alcohol or drug abuse

- Blood donation during the study, or 1 month before or after the study

NCT00853112
Pfizer
Terminated
A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension

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