A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.
Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
Summary
This is a clinical research study designed to evaluate sildenafil for the treatment of
Pulmonary Arterial Hypertension in children, aged 1 to 17 years. The purpose of the study is
to assess the efficacy, safety, and pharmacokinetics of 16 weeks of chronic treatment with
oral sildenafil given in three different doses, compared to placebo (inactive treatment).
Efficacy will be measured by exercise and hemodynamics. Patients who complete this trial may
be eligible to take part in an extension study, in which all patients will receive active
treatment of sildenafil.
Phase:
Phase 3
Details
Lead Sponsor:
Pfizer Pfizer's Upjohn has merged with Mylan to form Viatris Inc.