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
Latest Information Update: 07 Oct 2021
At a glance
- Drugs Evolocumab (Primary) ; Ezetimibe
- Indications Hypercholesterolaemia
- Focus Registrational; Therapeutic Use
- Acronyms GAUSS-2; PROFICIO
- Sponsors Amgen
- 27 Aug 2018 According to the European Clinical Trials Database (EudraCT2012-001364-30), Japan was the planned location.
- 17 Aug 2018 Results (n=3146) of pooled analysis of this and other three trials (LAPLACE-2, MENDEL-2, RUTHERFORD-2) published in the Clinical Cardiology.
- 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.