Decision: Favourable

Decisions Table

Study Title:

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential 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

  • NREC Code:

    22-NREC-CT-098

  • Decision:

    Favourable

  • Meeting Date:

    25/05/2022

  • Study Type:

    CT application

  • Principal Investigator:

    Prof Damien Kenny

  • PI Institution:

    CHI Crumlin

  • Sponsor:

    Actelion Pharmaceuticals Ltd

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