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

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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

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

Trial documents
2

Trial contacts and locations

82

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Data sourced from clinicaltrials.gov

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