AMG145 vs Ezetimibe in Statin Intolerant Hypercholesterolemic Subjects
Research type
Research Study
Full title
A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects
IRAS ID
140494
Contact name
Dermot Neely
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2013-000935-29
Clinicaltrials.gov Identifier
Research summary
People with high cholesterol levels in the blood are at a higher risk of developing heart problems. Statins, including atorvastatin, are a widely used class of drug used to lower cholesterol levels by inhibiting an enzyme which plays a central role in the production of cholesterol in the liver. Some patients cannot take statins due to intolerable myalgia (muscle pain, soreness, weakness, or cramps) or myopathy (myalgia together with an elevated level of a biochemical markers in the blood).
The purpose of this study is to find out more about a study product called AMG 145. AMG 145 binds to a natural protein that is produced by the liver. By binding to this protein AMG 145 allows LDL-cholesterol to be moved more efficiently out of the bloodstream. The study will be looking at AMG145 in participants who cannot tolerate statins.
Approximately 500 people are expected to participate in this study. This study will take place in approximately 45 centres in the United States of America, Europe, Australia, Canada and Asia.
This study will be divided into 3 parts (Parts A, B and C). Part A is designed to see if the participant is statin intolerant. They will have to meet certain criteria to demonstrate this. Part B will compare the safety and effectiveness of AMG 145 to ezetimibe, a cholesterol-lowering medication. Part B will last 6 months for each participant. In Part C, all participants who completed Part B will have the option of receiving AMG 145 for a period of 2 years to help determine the long term safety and efficacy of AMG 145.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
13/NE/0355
Date of REC Opinion
24 Dec 2013
REC opinion
Further Information Favourable Opinion