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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2004-05-31

Brief Summary

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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

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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.

Conditions

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Hyperlipidemia Mixed Hyperlipidemia Dyslipidemia

Keywords

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Hyperlipidemia Dyslipidemia Niacin Hydroxymethylglutaryl-CoA Reductase Inhibitors Combination lipid therapy Lovastatin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Niacin Extended Release/Lovastatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jason A Logan, MD

Role: PRINCIPAL_INVESTIGATOR

In His Image Family Medicine Residency

Edward Rylander, MD

Role: STUDY_CHAIR

In His Image Family Medicine Residency

Locations

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Family Medical Care of Tulsa

Tulsa, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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IHI-A001

Identifier Type: -

Identifier Source: org_study_id