A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor. GAUSS-2 Goal Achievement after Utilizing an anti-PCSK9 antibody in Statin Intolerant Subjects

Trial Profile

A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor. GAUSS-2 Goal Achievement after Utilizing an anti-PCSK9 antibody in Statin Intolerant Subjects

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Mar 2017

At a glance

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

    • 10 Jun 2017 Biomarkers information updated
    • 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.
    • 02 Sep 2015 Results (n=3146) of pooled analysis of this and other three trials (LAPLACE-2, RUTHERFORD-2, MENDEL-2) presented at the ESC Congress 2015: Annual Congress of the European Society of Cardiology
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