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To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85013 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Arterial 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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- Subjects with PAH (i.e. IPAH or secondary to connective tissue disease or with
surgical repair of ASD, VSD, PDA, aorto-pulmonary window) whose baseline six minute
walk test distance is >/= 100 m and = 450 m.

- Subjects with a mean pulmonary artery pressure of >/= 25 mmHg and a pulmonary artery
wedge pressure of = 15 mmHg at rest via right heart catheterization performed within
12 weeks prior to randomization.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects whose 6 Minute Walk Distance may be limited by conditions other than PAH
related dyspnoea or fatigue, e.g. claudication from vascular insufficiency or
significant arthritis.

- Subjects who are currently receiving any forms of chronic treatment for PAH such as
prostacyclin, PDE-5 inhibitors, endothelin-receptor antagonists, nitrates or nitric
oxide donors (e.g. arginine supplement, nicorandil) in any form, protease inhibitors
such as ritonavir and saquinavir, ketoconazole, itraconazole, and alpha blockers.
Subjects previously receiving any of these drugs must have stopped use for a period of
at least 1 month prior to screening, except in the case of bosentan or prostacyclin (3
months).

NCT00430716
Pfizer
Terminated
To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.

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Pfizer Clinical Trials Contact Center

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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