BENITIONSClinical Trial Intelligence

A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension

3期 进行中(已停止招募) NCT04175600

适应症Hypertension, Pulmonary
分期3期
申办方Actelion
状态进行中(已停止招募)
受试者人数138 人
干预(药物)Selexipag, Standard of Care (SOC): Endothelin receptor antagonist, SOC: Phosphodiesterase type 5 (PDE-5) inhibitor, SOC: Soluble guanylate cyclase stimulator
开始日期2020年1月16日
完成日期2024年10月11日
结果公布日2026年7月20日

摘要

The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.

Double-blind Period: Time to Disease Progression

Placebo arm: Randomization (Day 1) up to 7 days after last dose in the DB treatment (maximum up to 199 weeks); Selexipag arm: Randomization (Day 1) up to 7 days after last dose in the DB treatment (maximum up to 213 weeks) · Months

DB Period: Placebo35.29 Months
DB Period: SelexipagNA Months
Hazard Ratio (HR)1.081 (95% CI 0.607–1.926)

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。