Design and Rationale of the GAUSS‐2 Study Trial: A Double‐Blind, Ezetimibe‐Controlled Phase 3 Study of the Efficacy and Tolerability of Evolocumab (AMG 145) in Subjects With Hypercholesterolemia Who Are Intolerant of Statin Therapy

This article describes the rationale and design of the Goal Achievement After Utilizing an anti‐PCSK9 Antibody in Statin‐Intolerant Subjects 2 (GAUSS‐2) trial, a randomized, double‐blind, ezetimibe‐controlled, multicenter phase 3 study to evaluate the effects of 12 weeks of evolocumab 140 mg every 2 weeks or 420 mg every month in statin‐intolerant patients with hypercholesterolemia. Eligible subjects were unable to tolerate effective doses of ≥2 statins because of myalgia, myopathy, myositis, or rhabdomyolysis that resolved with statin discontinuation. The primary objective of the study is to assess the effects of evolocumab on percentage change from baseline in LDL‐C. Secondary objectives include evaluation of safety and tolerability, comparison of the effects of evolocumab vs ezetimibe on absolute change from baseline in LDL‐C, and percentage changes from baseline in other lipids. Recruitment of approximately 300 subjects was completed in August 2013.
Source: Clinical Cardiology - Category: Cardiology Authors: Tags: Trial Designs Source Type: research