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Open-label, Single-Arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH)

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Trial Profile

Open-label, Single-Arm, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Evolocumab for LDL-C Reduction, as Add-on to Diet and Lipid-lowering Therapy, in Pediatric Subjects From 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Mar 2024

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At a glance

  • Drugs Evolocumab (Primary)
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Adverse reactions
  • Acronyms HAUSER-OLE
  • Sponsors Amgen

    • Most Recent Events

    • 15 Feb 2024 Results of cognitive function during 80 weeks , published in the European Journal of Preventive Cardiology
    • 12 Sep 2023 Planned number of patients changed from 115 to 124.
    • 29 Aug 2022 Results assessing the effect of evolocumab treatment on cIMT progression in paediatric patients with heterozygous familial hypercholesterolaemia in HAUSER-RCT & HAUSER-OLE, presented at the ESC Congress 2022 - Annual Congress of the European Society of Cardiology.
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