Effects of Oral Sildenafil on Mortality in Adults With PAH

• Status: Completed
• Trial end date: 2021-02-26
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Citric Acid; Sildenafil Citrate; Sodium Citrate

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