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Effects of Oral Sildenafil on Mortality in Adults With PAH

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NCT02060487

Last updated on December 9, 2018
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FOR MORE INFORMATION
Study Location
Emory University Investigational Drug Services
Atlanta, Georgia, 30322 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.
Show details

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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Effects of Oral Sildenafil on Mortality in Adults With PAH
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: sildenafil citrate
    sildenafil citrate (PDE-5 inhibitor) 5 mg tablet TID until study treatment discontinued or end of study
    Other Name: Revatio
  • Drug: sildenafil citrate
    sildenafil citrate (PDE-5 inhibitor) 20 mg tablet TID until study treatment discontinued or end of study
    Other Name: Revatio
  • Drug: sildenafil citrate
    sildenafil citrate (PDE-5 inhibitor) 80 mg tablet TID until study treatment discontinued or end of study
    Other Name: Revatio
  • Experimental: Low dose
    Intervention: Drug: sildenafil citrate
  • Experimental: Medium dose
    Intervention: Drug: sildenafil citrate
  • Experimental: High dose
    Intervention: Drug: sildenafil citrate
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
429
September 11, 2025
September 11, 2025   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 74 Years   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Australia,   Belgium,   Bosnia and Herzegovina,   Croatia,   Czechia,   Germany,   Greece,   Israel,   Malaysia,   Mexico,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Singapore,   South Africa,   Spain,   Thailand,   Ukraine,   United States
Austria,   Czech Republic
 
NCT02060487
A1481324
2013-004362-34 ( EudraCT Number )
AFFILIATE ( Other Identifier: Alias Study Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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