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

In His Image

Status and phase: Completed; Phase 4

Conditions: Mixed Hyperlipidemia; Hyperlipidemia; Dyslipidemia

Treatments: Drug: Niacin Extended Release/Lovastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00345657

IHI-A001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)