The Lipid Efficacy and Safety Add-On Study.
Research type
Research Study
Full title
A 24-Week, Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Patients with Hypercholesterolemia or Low HDL-C
IRAS ID
117311
Contact name
Handrean Soran
Contact email
Sponsor organisation
Merck Sharpe & Dohme Corp
Eudract number
2012-003110-14
Research summary
Hypercholesterolemia is the presence of high levels of cholesterol in the blood. It is a form of hyperlipidaemia (elevated levels of lipids in the blood), typically caused by combination of environmental (obesity and dietary choices) and genetic factors. Established lipid lowering therapies are not always sufficient to reduce the LDL-C levels (low density lipoprotein cholesterol or ??bad cholesterol??) to target levels for some patients. Anacetrapib is being developed to reduce the risk of heart attack and stroke. The drug lowers the activity of a protein, cholesteryl ester transfer protein (CETP), in blood to decrease the amount of LDL-C (bad cholesterol) and increase the amount of HDL-C (good cholesterol). These changes are usually associated with a lower risk of heart attack and stroke. The purpose of this study is to further assess the safety of the research study drug, anacetrapib and test how effective anacetrapib is at lowering bad cholesterol (LDL-C) and increasing good cholesterol (HDL-C) when compared to placebo (a look-alike tablet with no active ingredients, sometimes called a sugar pill) and added to a stable dose of a statin. The study drug will be taken in addition to the patient??s ongoing lipid lowering therapy. Approximately 450 people with hypercholesterolemia aged 18-80 will take part in this study worldwide and will receive treatment for 24 weeks. Participants will be assigned by chance to get either anacetrapib 100mg, anacetrapib 25mg or placebo. (There is a 1 in 3 chance of getting placebo only). Participants will need to visit the study doctor about 6 times, plus a final visit 12 weeks after their last dose of study medication. Procedures performed will include physical examinations, blood tests and ECGs (electrocardiogram to measure the electrical activity of the heart).
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
12/NW/0795
Date of REC Opinion
12 Dec 2012
REC opinion
Further Information Favourable Opinion