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Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care

Information source: In His Image
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperlipidemia; Mixed Hyperlipidemia; Dyslipidemia

Intervention: Niacin Extended Release/Lovastatin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: In His Image

Official(s) and/or principal investigator(s):
Jason A Logan, MD, Principal Investigator, Affiliation: In His Image Family Medicine Residency
Edward Rylander, MD, Study Chair, Affiliation: In His Image Family Medicine Residency

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.

Clinical Details

Official title: Extended-Release Niacin/Lovastatin Versus Usual Care for Treatment of Dyslipidemia in a Primary Care Setting (EXTEND Study)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Lipid parameter change at 3 and 6 months

Percent of patients achieving ATP III LDL goals at 3 and 6 months

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 (AdvicorŪ) 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Family Medical Care of Tulsa, Tulsa, Oklahoma 74136, United States
Additional Information

Starting date: July 2003
Last updated: June 27, 2006

Page last updated: August 23, 2015

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