小児肺動脈性肺高血圧症におけるシルデナフィルの安全性と有効性

基本情報

NCT ID

NCT01642407

ステータス

完了

試験のフェーズ

第4相

試験タイプ

介入

目標被験者数

6

治験依頼者名

Pfizer

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (5)