A Study of LY2484595 in Patients With High LDL-C or Low HDL-C
Status: | Completed |
---|---|
Conditions: | High Cholesterol, High Cholesterol |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | April 2010 |
End Date: | June 2011 |
A Phase 2 Efficacy and Safety Study of LY2484595 Alone and in Combination With Atorvastatin, Simvastatin, and Rosuvastatin in Patients With Hypercholesterolemia or Low HDL-C
The primary purpose of your participation in this study is to help answer the following
research question(s)
- Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or
rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the
blood fat profile more than statins alone.
- Whether LY2484595 alone improves blood fats profile compared to sugar pills.
- Whether LY2484595 interferes with break down or functioning of statins.
- Whether LY2484595 has any side effects that would not support testing it in future
studies.
research question(s)
- Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or
rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the
blood fat profile more than statins alone.
- Whether LY2484595 alone improves blood fats profile compared to sugar pills.
- Whether LY2484595 interferes with break down or functioning of statins.
- Whether LY2484595 has any side effects that would not support testing it in future
studies.
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 meal of the day.
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 meal of the day.
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
We found this trial at
39
sites
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