A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia

Trial Profile

A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Mar 2017

At a glance

  • Drugs Evolocumab (Primary) ; Atorvastatin; Ezetimibe; Rosuvastatin; Simvastatin
  • Indications Dyslipidaemias; Hypercholesterolaemia; Hyperlipidaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms LAPLACE-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 (MENDEL-2, RUTHERFORD-2, GAUSS-2) presented at the ESC Congress 2015: Annual Congress of the European Society of Cardiology
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