Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension
Status:
Completed
Trial end date:
2018-03-12
Target enrollment:
Participant gender:
Summary
Pulmonary arterial hypertension (PAH) is a rare, progressive, and life-threatening disease.
In many patients, the course of PAH is a steady deterioration and reduced life expectancy.
Sildenafil was approved by the European Commission for the treatment of PAH in pediatric
patients in May 2011, making it the first agent to be approved for the treatment of children
with PAH. The approval was based on the largest placebo-controlled study to be conducted in
this population. The recommended dose in pediatric patients aged 1 year to 17 years old is 10
mg TID in patients ≤ 20 kg and 20 mg TID for patients > 20 kg. Higher doses are not
recommended in pediatrics patients.
This study is an open-label, multi-center study to investigate safety, efficacy and
pharmacokinetics of sildenafil citrate in Japanese pediatric patients with PAH.
Phase:
Phase 4
Details
Lead Sponsor:
Pfizer Pfizer's Upjohn has merged with Mylan to form Viatris Inc.