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A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233 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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Included patients had primary pulmonary arterial hypertension, pulmonary hypertension
secondary to connective tissue disease, or pulmonary hypertension with surgical repair at
least 5 years previously; a mean pulmonary artery pressure greater than or equal to 25 mmHg
and a pulmonary artery wedge pressure of less than or equal to 15 mmHg at rest, via right
heart catheterisation within 21 days prior to randomisation; and a baseline 6-Minute Walk
test distance of 100 m to 450 m.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Subjects with congenital heart disease, pulmonary hypertension due to thromboembolism, HIV,
chronic obstructive airway disease, congestive heart failure or schistosomiasis; subjects
with significant (ie > 2+) valvular disease other than tricuspid regurgitation or pulmonary
regurgitation; and acutely decompensated heart failure within the previous 30 days;
subjects with pulmonary hypertension secondary to any other etiology other than those
specified in the inclusion criteria.

NCT00644605
Pfizer
Completed
A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension

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[email protected]

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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