A Multicenter, Randomized Study in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia to Assess Subjects' Ability to Administer a Full Dose of Evolocumab (AMG 145) in Home-use, Using Either a 3.5 mL Personal Injector or a Prefilled Autoinjector/Pen.

Trial Profile

A Multicenter, Randomized Study in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia to Assess Subjects' Ability to Administer a Full Dose of Evolocumab (AMG 145) in Home-use, Using Either a 3.5 mL Personal Injector or a Prefilled Autoinjector/Pen.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Mar 2017

At a glance

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

    • 01 Mar 2017 Results (n=6026) of pooled safety analysis of this and other eleven trials (LAPLACE-TIMI 57,RUTHERFORD,GAUSS,MENDEL,YUKAWA,LAPLACE-2,RUTHERFORD-2,GAUSS-2,MENDEL-2,DISCARTES,THOMAS-1,THOMAS-2) published in the Circulation.
    • 28 Aug 2014 Amgen submitted a BLA to the US FDA for evolocumab based on data from this trial and 9 other trials in the PROFICIO programme, according to a media release.
    • 05 Feb 2014 Status changed from active, no longer recruiting to completed.
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