Summary
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER LONG-TERM SAFETY AND TOLERABILITY STUDY OF ETC-1002 IN PATIENTS WITH HYPERLIPIDEMIA AT HIGH CARDIOVASCULAR RISK WHO ARE NOT ADEQUATELY CONTROLLED BY THEIR LIPID-MODIFYING THERAPY
Total # of Subjects Needed:
About 900 men and women over the age of 18 in approximately 125 sites located in the United States, Canada, Germany, Netherlands, Poland, and the United Kingdom
Study Details
If you have high LDL-C levels you have a high or very high risk of developing major cardiovascular (CV) events (such as heart attack, stroke, sometimes known as a brain attack, or hospitalization for chest pain due to poor blood flow to the heart). You are at risk for developing one of these cardiac events, either because you have had a previous heart attack or stroke, or because you have a condition such as diabetes, kidney disease, hardening of the arteries of the legs, or an inherited disorder of high cholesterol. All subjects who agree to volunteer as a participant in the study should currently be treated with what is now recommended care to reduce the chance of having one of the CV events we have just described, with a statin or non-statin lipid lowering therapy. The purpose of this research study is to compare the effects of the study drug, to a placebo to find out how effective and safe the study medication is in reducing the risk of major cardiovascular events, (heart attacks, strokes, and hospitalization for chest pain), when added to other cholesterol treatments. You will remain on your current cholesterol lowering treatment.
A placebo looks like the study drug but does not contain any drug. Researchers use a placebo to see if the study drug works better or is safer than not taking anything else. The term “study drug” refers to both active drug and placebo.
Increased levels of so called “bad” cholesterol, called LDL cholesterol (LDL-C), is a known risk factor for cardiovascular disease. Statins and other cholesterol treatments lower levels of the bad cholesterol and have been shown to reduce the chance of someone having a heart attack or a stroke. The study medication is a new investigational drug. A new investigational drug is one that has not been shown to be a proven treatment and is currently not approved for sale in any country. The study drug works by lowering LDL-C levels and may reduce the risk of heart attacks, strokes, and hospitalizations for chest pain due to heart disease. Because this is a research study, the study drug will be given to you only during this study and not after the study is over.
Watch an excellent video on LDL and HDL HERE.
Apply for study
If you would like to learn more about the different study opportunities you may call 1-800-530-0998 or for local callers please call 801-356-5555. To apply for this study you may also fill out the online application HERE.