ODYSSEY CHOICE
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients with Primary Hypercholesterolemia
IRAS ID
137310
Contact name
Babatunde Oyesile
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2013-002343-29
Research summary
Current cholesterol lowering medications include: statins, cholesterol absorption inhibitors, fibrates, niacin, and bile acid sequestrants. Statins are the most commonly prescribed, as they have shown a greater ability to lower cholesterol and reduce coronary heart disease events. However, despite these available treatments, which can be used in combination, many high-risk patients fail to reach their guideline target cholesterol level.
The purpose of the study is to determine if the study drug (alirocumab), given by injection under the skin every 4 weeks is effective and safe compared with placebo in lowering cholesterol, if used alone or added to the participants’ current cholesterol-lowering medication.
The study will enrol 700 male and female patients worldwide. Participation may last up to 14 months and include a maximum of 17 or 18 scheduled visits. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug (including blood lipid levels, vital signs, physical examination, Electrocardiogram and blood/urine sample collection for other laboratory tests).
The study will be conducted at 7 dedicated research centres in the UK
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0607
Date of REC Opinion
21 Oct 2013
REC opinion
Further Information Favourable Opinion