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)

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)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Oct 2017

At a glance

  • Drugs Evolocumab (Primary)
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Adverse reactions; Registrational
  • Acronyms HAUSER-OLE
  • Sponsors Amgen
  • Most Recent Events

    • 05 Oct 2017 Planned End Date changed from 29 Sep 2019 to 1 Jan 2021.
    • 05 Oct 2017 Planned primary completion date changed from 29 Sep 2019 to 1 Jan 2021.
    • 10 Jun 2017 Biomarkers information updated
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