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A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged ≥2 to <18 Years With Pulmonary Arterial Hypertension

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Trial Profile

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged ≥2 to <18 Years With Pulmonary Arterial Hypertension

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Sep 2025

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At a glance

  • Drugs Selexipag (Primary) ; Bosentan
  • Indications Pulmonary arterial hypertension
  • Focus Registrational; Therapeutic Use
  • Acronyms SALTO
  • Sponsors Actelion Pharmaceuticals; Janssen Research & Development

Most Recent Events

  • 10 Sep 2025 New source identified and integrated (Clinical Trials Information System : CTIS2022-501012-34-00)
  • 04 Dec 2024 Planned End Date changed from 10 Jan 2028 to 1 Oct 2027.
  • 19 Sep 2024 This trial is ongoing in Belgium according to European Clinical Trials Database record.

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