Effects of Oral Sildenafil on Mortality in Adults With PAH (AFFILIATE)

Viatris

Status and phase: Terminated; Phase 4

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: sildenafil citrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02060487

2013-004362-34 (EudraCT Number)

A1481324

AFFILIATE (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 385 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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385 participants in 3 patient groups

Low dose

Experimental group

Treatment:

Drug: sildenafil citrate

Drug: sildenafil citrate

Drug: sildenafil citrate

Medium dose

Experimental group

Treatment:

Drug: sildenafil citrate

Drug: sildenafil citrate

Drug: sildenafil citrate

High dose

Experimental group

Treatment:

Drug: sildenafil citrate

Drug: sildenafil citrate

Drug: sildenafil citrate