A Study of Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension
Phase 3
Active, not recruiting
NCT04175600
| Condition | Hypertension, Pulmonary |
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| Phase | Phase 3 |
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| Sponsor | Actelion |
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| Status | Active, not recruiting |
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| Enrollment | 138 participants |
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| Interventions | Selexipag, Standard of Care (SOC): Endothelin receptor antagonist, SOC: Phosphodiesterase type 5 (PDE-5) inhibitor, SOC: Soluble guanylate cyclase stimulator |
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| Start date | Jan 16, 2020 |
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| Completion date | Oct 11, 2024 |
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| Results posted | Jul 20, 2026 |
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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: Placebo | 35.29 Months |
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| DB Period: Selexipag | NA Months |
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| Hazard Ratio (HR) | 1.081 (95% CI 0.607–1.926) |
Open in BENITIONS
View on ClinicalTrials.gov
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