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Double-blind, Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Characterize the Efficacy, Safety, and Tolerability of 24 Weeks of Evolocumab for Low Density Lipoprotein-Cholesterol (LDL-C) Reduction, as Add-On to Diet and Lipid-Lowering Therapy, in Pediatric Subjects 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH)

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Trial Profile

Double-blind, Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Characterize the Efficacy, Safety, and Tolerability of 24 Weeks of Evolocumab for Low Density Lipoprotein-Cholesterol (LDL-C) Reduction, as Add-On to Diet and Lipid-Lowering Therapy, in Pediatric Subjects 10 to 17 Years of Age With Heterozygous Familial Hypercholesterolemia (HeFH)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Oct 2022

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At a glance

  • Drugs Evolocumab (Primary)
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Acronyms HAUSER-RCT
  • Sponsors Amgen

    • Most Recent Events

    • 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.
    • 22 Aug 2022 According to an Amgen media release, data from this trial will be presented as a late-breaking Hot Line Oral Presentation at the European Society of Cardiology Congress 2022.
    • 27 Sep 2021 According to an Amgen media release, based on the data from this study, the U.S. Food and Drug Administration (FDA) has approved Repatha (evolocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C)-lowering therapies for the treatment of pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C.
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