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A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG145) on LDL-C in Combination With Statin Therapy in Japanese Subjects With High Cardiovascular Risk and With Hyperlipidemia or Mixed Dyslipidemia

Trial Profile

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG145) on LDL-C in Combination With Statin Therapy in Japanese Subjects With High Cardiovascular Risk and With Hyperlipidemia or Mixed Dyslipidemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jun 2016

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At a glance

  • Drugs Evolocumab (Primary)
  • Indications Dyslipidaemias; Hyperlipidaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms PROFICIO; YUKAWA-2
  • Sponsors Amgen
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 28 Jan 2016 According to an Amgen media release, evolocumab is approved in Japan for the treatment of Hyperlipidemia or hypercholesterolemia.
    • 28 Jan 2016 According to an Amgen media release, the CV imaging and outcomes data is expected in the second half of 2016
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