Are you 65 or over with high cholesterol?

  • STATUS
    Recruiting
Updated on 8 November 2020

Summary

Are you 65 or over with high cholesterol?

Description

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 following:

  • 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 OR
  • 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 atorvastatin

For more information,

Details
Clinical Study IdentifierTX134268
Last Modified on8 November 2020

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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