2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia

Trial Profile

2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia

Completed
Phase of Trial: Phase II/III

Latest Information Update: 22 Mar 2017

At a glance

  • Drugs Evolocumab (Primary)
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Acronyms PROFICIO; TESLA
  • Sponsors Amgen
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 01 Oct 2014 According to an Amgen media release, results from phase III portion were published in The Lancet.
    • 01 Oct 2014 Amgen plans to submit regulatory filings to US and EU for evolocumab based on the data from TESLA, RUTHERFORD-2 and few other studies in the clinical trial programme.
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