Clinical Trial: Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Extended-Release Niacin/Lovastatin Versus Usual Care for Treatment of Dyslipidemia in a Primary Care Setting (EXTEND Study)
Brief Summary: The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.
Detailed Summary: Both LDL and HDL are important contributors in the pathophysiology of atherosclerosis and coronary artery disease (CAD); however, HDL is often ignored in primary care. The combination of niacin extended-release (ER)/lovastatin in a single tablet formulation (Advicor®) may be the most effective therapeutic option for simultaneously correcting both of these lipoprotein abnormalities to reduce CAD risk. The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.
Sponsor: In His Image
Current Primary Outcome:
- Lipid parameter change at 3 and 6 months
- Percent of patients achieving ATP III LDL goals at 3 and 6 months
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: In His Image
Dates:
Date Received: June 27, 2006
Date Started: July 2003
Date Completion: May 2004
Last Updated: June 27, 2006
Last Verified: June 2006