A Study of LY2484595 in Patients With High LDL-C or Low HDL-C

Launched by ELI LILLY AND COMPANY · Apr 15, 2010

Keywords

ClinConnect Summary

Patients will be stratified according to baseline levels of serum triglycerides (\<150 or greater than or equal to 150 milligram/deciliter (mg/dL), HDL-C (\<45 or greater than or equal to 45 mg/dL for men; \<50 or greater than or equal to 50 mg/dL for women), and region (United States or Europe). After a diet lead-in and prior therapy washout phase, subjects meeting all entry criteria will be randomized to one of 10 double-blind treatment groups for a 12 week treatment phase. After randomization, patients will self-administer the study drugs once a day with a low fat meal as their first mea...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Diagnosed with Low High Density Lipoprotein Cholesterol (HDL-C) or hypercholesterolemia, after diet lead-in/washout of lipid therapies
• Exclusion Criteria:
• • History of coronary heart disease, or hardening of the arteries, or heart does not pump sufficiently well
• • Hypertension or high blood pressure that is not under control or your study physician does not consider the electrical activity of heart (Electrocardiogram \[ECG\]) to be compatible with participation in the study
• • History of a bad skin rash, a prior rash due to a drug or a history of chronic skin disorder (such as psoriasis or eczema)
• • Intolerance to certain lipid modifying drugs (including statins and Cholesteryl Ester Transfer Protein (CETP) inhibitors)
• • Not willing to stop taking prescription or over the counter drugs you use to control fats in your blood (like fish oil, niacin or statin) or pills to decrease your weight, including herbs
• • Not willing to follow the diet (low-fat) that the study physician will recommend
• • Have disease of liver, kidneys, muscles or other organs of body, a serious infection or cancer, or abnormal laboratory tests that study physician does not consider compatible with participation in the study
• • Breastfeeding woman or a woman who can still become pregnant, but are not willing to use a valid birth control measure to prevent pregnancies