Skip Navigation

Advertise|Press|Contact|FAQ|CWConnect

Bookmark/Print/Share

Home » Clinical Trials » Therapeutic Areas
Therapeutic Areas: Cardiology/Vascular Diseases | Endocrinology | Family Medicine
Disease Category: High Cholesterol (Hyperlipidemia)
Location: United States, CT

Clinical Trial Details

Overview

Research Study Summary

Are you 65 or over with high cholesterol?

Purpose

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,

To Learn more
Phase

3

Gender

Both Male and Female

Age

65 and up

Overall Status

Recruiting

Duration

19 Weeks

Facility Type

N/A

Contact

Tom Grotta, President
Stamford Therapeutics Consortium
47 Oak Street
Stamford, CT 06905
Phone: 203-325-8529
Fax: 203-325-0069

View Map

Research Center Information: Stamford Therapeutics Consortium

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

Name:
Address:
City:
State:
Zip/Postal Code:
Country:
Phone:
Email:  
Message:
 
Please leave this field empty.

CW ID: 109267

Date Last Changed: July 25, 2013


DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.