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...
Date First Received: June 27, 2006
Last Updated: June 27, 2006
Verified by: In His Image, June 2006
Clinical Trial Phase: Phase 4 | Start Date: July 2003
Overall Status: Completed
Estimated Enrollment: 100
Brief Summary
Official Title: “Extended-Release Niacin/Lovastatin Versus Usual Care for Treatment of Dyslipidemia in a Primary Care Setting (EXTEND Study)”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Niacin Extended Release/Lovastatin
Outcome Measures for this Clinical Trial
Primary Measures
- Lipid parameter change at 3 and 6 months
- Percent of patients achieving ATP III LDL goals at 3 and 6 months
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 1. >18 years old with CAD or risk factors for CAD
- 2. under standard care at Family Medical Care of Tulsa
- 3. not at LDL goal per ATP III guidelines
Exclusion Criteria:
- 1. pregnancy/lactating
- 2. liver disease
- 3. allergies to statin or niacin
- 4. active peptic ulcer disease
- 5. previous treatment with combination therapy for dyslipidemia
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: In His Image
Overall Clinical Trial Officials and Contacts
Jason A Logan, MD Principal Investigator In His Image Family Medicine Residency
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00345657
Study ID Number: IHI-A001
ClinicalTrials.gov Identifier: NCT00345657
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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