Effects of Oral Sildenafil on Mortality in Adults With PAH

Stopped early · Phase 4

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT02060487

Run by

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

People needed

385

Starts

2014-09-22

Expected to finish

2021-02-26

Last updated by the study team

2022-05-13

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Emory Clinic — Atlanta, Georgia, United States
• Frederik Meijer Heart & Vascular Institute Cardiovascular Research — Grand Rapids, Michigan, United States
• Spectrum Health Butterworth Hospital IDS Pharmacy — Grand Rapids, Michigan, United States
• Spectrum Health Heart & Lung Specialized Care Clinic — Grand Rapids, Michigan, United States
• Spectrum Health Hospitals — Grand Rapids, Michigan, United States
• Spectrum Health Medical Group - Pulmonary Division — Grand Rapids, Michigan, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• Robert V. Sibilia MD, Inc. — Wooster, Ohio, United States
• UT Southwestern Medical School — Dallas, Texas, United States
• Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States
• St. Vincent's Hospital — Darlinghurst, New South Wales, Australia
• Westmead Hospital — Westmead, New South Wales, Australia
• Royal Brisbane & Women's Hospital — Herston, Queensland, Australia
• Australian Respiratory and Sleep Medicine Institute — Bedford Park, South Australia, Australia
• University Hospital of Mont-Godinne — Yvoir, Belgium
• University Clinical Center of the Republic of Srpska — Banja Luka, B&h/republic of Srpska, Bosnia and Herzegovina
• Clinical Center University Sarajevo — Sarajevo, Bosnia and Herzegovina/canton Sarajevo, Bosnia and Herzegovina
• Health Institution Special Hospital "Medical Institute Bayer" — Tuzla, Canton Tuzla, Bosnia and Herzegovina
• University Clinical Hospital Mostar — Mostar, Herzegovina-neretva Canton, Bosnia and Herzegovina
• University Hospital Center Zagreb — Zagreb, Croatia
• University Hospital Dubrava — Zagreb, Croatia
• Vseobecna fakultni nemocnice v Praze — Prague, Czech Republic, Czechia
• Fakultni nemocnice Olomouc — Olomouc, Czechia
• Institut Klinicke a Experimentalni Mediciny — Prague, Czechia
• Emory University Investigational Drug Services — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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