AMG 145 20120153 GLAGOV

Project

AMG 145 20120153 GLAGOV

Completed · 2014 until 2018

Rickli Hans, Weilenmann Daniel, Gemperle Michaela, Rigger Johannes

Type

Clinical Studies

Range

Multicentric, KSSG as participating partner

Units

Kardiologie

Status

Completed

Start Date

2014

End Date

2018

Financing

Industry

Study Design

Study Design This is a Phase III, multi-center, double-blind, randomized, placebo-controlled study evaluating the effect of AMG 145 on coronary atherosclerotic disease burden as assessed by intravascular ultrasound (IVUS) at baseline and following 78 weeks of treatment in subjects with coronary artery disease. Subjects will be randomized 1:1 into 2 treatment groups: AMG 145 420 mg on a monthly basis (QM) SC or placebo QM SC. Randomization will be stratified for balance by geographic region.

Brief description/objective

Double-Blind, Randomized, Multi-Center, Placebo-Controlled, Parallel Group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden
As Measured By Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization

Primary Objective
To evaluate the effect of AMG 145 on the change in burden of coronary atherosclerosis as
measured by percent atheroma volume (PAV) in subjects with coronary artery disease (CAD)
requiring angiography for a clinical indication who are taking statins.
Secondary Objectives
To evaluate the effect of AMG 145 on the change in normalized total atheroma volume (TAV)
and the percentage of subjects who demonstrate regression of coronary atherosclerosis.
Hypothesis: The primary hypothesis is that (low-density lipoprotein cholesterol) LDL-C lowering
with AMG 145 420 mg subcutaneous (SC) will result in a greater change from baseline in PAV
at week 78 than placebo in subjects with coronary artery disease taking background statin
therapy.