Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care
- Conditions
- HyperlipidemiaMixed HyperlipidemiaDyslipidemia
- Registration Number
- NCT00345657
- Lead Sponsor
- In His Image
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- >18 years old with CAD or risk factors for CAD
- under standard care at Family Medical Care of Tulsa
- not at LDL goal per ATP III guidelines
- pregnancy/lactating
- liver disease
- allergies to statin or niacin
- active peptic ulcer disease
- previous treatment with combination therapy for dyslipidemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Lipid parameter change at 3 and 6 months Percent of patients achieving ATP III LDL goals at 3 and 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Family Medical Care of Tulsa
🇺🇸Tulsa, Oklahoma, United States