BENITIONSClinical Trial Intelligence

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

Phase 3 Active, not recruiting NCT04175600

ConditionHypertension, Pulmonary
PhasePhase 3
SponsorActelion
StatusActive, not recruiting
Enrollment138 participants
InterventionsSelexipag, Standard of Care (SOC): Endothelin receptor antagonist, SOC: Phosphodiesterase type 5 (PDE-5) inhibitor, SOC: Soluble guanylate cyclase stimulator
Start dateJan 16, 2020
Completion dateOct 11, 2024
Results postedJul 20, 2026

Summary

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)

Open in BENITIONS View on ClinicalTrials.gov

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