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Therapeutic Areas: Cardiology/Vascular Diseases | Endocrinology | Family Medicine
Disease Category: High Cholesterol (Hyperlipidemia)
Location: United States, CT
Clinical Trial Details
Research Study Summary
Are you 65 or over with high cholesterol?
Researchers want to find out if a drug called ezetimibe (Zetia)
can help people with high cholesterol who are at high risk for
heart disease. The purpose of this study is to give ezetimibe to
some people to see if it is safe and can help them when taken with
another drug called atorvastatin (Lipitor). The study doctor is
also doing this study to see if taking ezetimibe and atorvastatin
together is better than taking atorvastatin alone.
Both ezetimibe and atorvastatin are approved by the FDA for us
in people with high cholesterol. Giving people ezetimibe and
atorvastatin together for high cholesterol is an approved and
acceptable use of both drugs; however, for purposes of this study,
giving these drugs together will be considered an investigational
use of the drugs. The word "investigational" means this
use is still being tested and is not approved by the FDA for people
who are at high risk for heart disease.
As part of this study you will be asked the
- Visit STC 5-6 times over 18-19 weeks.
- Take 3 pills per day for 16-17 weeks
- Fast for 12 hours before each office visit
Patient Inclusion Criteria
- 65 or over
- Patient is naïve to lipid lowering therapy OR
- Patient is currently taking a stable dose of atorvastatin 10mg
and by history has taken > 80% of daily doses for 6 weeks
- Patient is currently taking a stable dose of one of the lipid
lowering therapies listed below and by history has taken > 80%
of daily doses for 6 weeks.
- Simvastatin 10, 20, or 40 mg
- Atorvastatin 20 mg
- Pravastatin 10, 20, or 40 mg
- Fluvastatin 20, 40, or 80 mg
- Ezetimibe 10 mg
- Lovatatin 10, 20 or 40 mg
- Rosuvastatin 5 mg
- Patients has coronary and other vascular disease with LDL = 70
and = 160
- Patient without atherosclerotic vascular disease who have
diabetes or multiple risk factors and a 10 year risk for CHD >
20% with LDL = 100 and = 190
Patient Exclusion Criteria
- Patient has hypersensitivity to ezetimibe or
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Both Male and Female
Date Last Changed:
July 25, 2013
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