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A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Evolocumab, Compared With Ezetimibe, in Hypercholesterolemic Japanese Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects

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Trial Profile

A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Evolocumab, Compared With Ezetimibe, in Hypercholesterolemic Japanese Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Evolocumab (Primary) ; Ezetimibe
  • Indications Hypercholesterolaemia
  • Focus Therapeutic Use
  • Acronyms GAUSS-4
  • Sponsors Amgen

    • Most Recent Events

    • 18 Jun 2019 According to an Amgen Astellas BioPharma media release, company has received supplemental indiaction approval in Japan for Repatha SC Injection as monotherapy for treating hypercholesterolemia patients with statin intolerance.
    • 03 Aug 2018 Amgen Astellas has filed an application for supplemental indication in Japan for Repatha SC Injection 140 mg in treating hypercholesterolemic patients with statin intolerance, based on the results of this trial, according to an Astellas Pharma media release.
    • 31 May 2018 Status changed from active, no longer recruiting to completed.
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