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Effects of Oral Sildenafil on Mortality in Adults With PAH
Effects of Oral Sildenafil on Mortality in Adults With PAH

NCT02060487

TerminatedPhase 4

Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Conditions: Pulmonary Arterial Hypertension

Interventions: sildenafil citrate, sildenafil citrate, sildenafil citrate

Countries: United States, Australia, Belgium, Bosnia and Herzegovina, Croatia, Czechia, Germany, Greece

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 74 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (82)
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Grand Rapids, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Wooster, Ohio, United States
  • Dallas, Texas, United States
  • Milwaukee, Wisconsin, United States
  • Darlinghurst, New South Wales, Australia
  • Westmead, New South Wales, Australia
  • Herston, Queensland, Australia
  • Bedford Park, South Australia, Australia
  • Yvoir, Belgium
  • Banja Luka, B&h/republic of Srpska, Bosnia and Herzegovina
  • Sarajevo, Bosnia and Herzegovina/canton Sarajevo, Bosnia and Herzegovina
  • Tuzla, Canton Tuzla, Bosnia and Herzegovina
  • Mostar, Herzegovina-neretva Canton, Bosnia and Herzegovina
  • Zagreb, Croatia
  • Zagreb, Croatia
  • Prague, Czech Republic, Czechia
  • Olomouc, Czechia
  • Prague, Czechia
  • Berlin, Germany
  • Dresden, Germany
  • Dresden, Germany
  • Greifswald, Germany
  • Hamburg, Germany
  • + 52 more on CT.gov