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Effects of Oral Sildenafil on Mortality in Adults With PAH

Last updated on June 14, 2019

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Study Location
Marmara University Pendik Training and Research Hospital
Istanbul, Pendik, 34899 Turkey
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
18-74 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Subjects ≥ 18

- Idiopathic Primary Pulmonary Arterial Hypertension (IPAH)

- PAH secondary to connective tissue disease

- PAH with surgical repair (at least 5 years previously) of atrial septal defect
(ASD),ventricular septal defect (VSD), patent ductus arteriosus (PDA) and
aorto-pulmonary window

- PAH diagnosis confirmed by right heart catheterization performed within 12 months
prior to randomization

- Functional Class II-IV; Baseline 6MWD ≥ 50 m.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary
regurgitation

- History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular
tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation

- History of pulmonary embolism; History of chronic lung disease / restrictive lung
disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with
impairment of lung function

- No prior long term treatment with PDE-5 inhibitors

- Treatment with bosentan OR riociguat within 3 months of randomization

- Current treatment with nitrates or nitric oxide

NCT02060487
Pfizer
Recruiting
Effects of Oral Sildenafil on Mortality in Adults With PAH

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