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Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Adolescents (12 to Less Than 18 Years) With Homozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol (ORION-13)

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Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Adolescents (12 to Less Than 18 Years) With Homozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol (ORION-13)

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

Latest Information Update: 26 Mar 2024

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At a glance

  • Drugs Inclisiran (Primary)
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Acronyms ORION-13
  • Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals

    • Most Recent Events

    • 21 Mar 2024 Planned End Date changed from 30 Nov 2024 to 2 Dec 2024.
    • 14 Jun 2023 This trial has been Completed in Slovenia, According to European Clinical Trials Database record.
    • 19 May 2023 Planned End Date changed from 29 Nov 2024 to 30 Nov 2024.

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