Effects of Oral Sildenafil on Mortality in Adults With PAH



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 74
Updated:3/28/2019
Start Date:September 22, 2014
End Date:December 31, 2023
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)

This is a blinded study in adult patients with PAH evaluating the relative effects of
sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three
times per day [TID]). In addition, the relative effects on clinical worsening and 6-minute
walking distance (6MWD) will be assessed.


Inclusion Criteria:

Subjects ≥ 18 <75 years of age with any of the following conditions:

- 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:

- 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
We found this trial at
13
sites
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Atlanta, GA
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Atlanta, Georgia 30322
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Darlinghurst, New South Wales 2010
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Darlinghurst,
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Grand Rapids, MI
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Grand Rapids, Michigan 49503
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Grand Rapids, MI
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Grand Rapids, Michigan 49503
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Grand Rapids, MI
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Milwaukee, WI
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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mi
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Milwaukee, WI
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Wooster, Ohio 44691
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Wooster, OH
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