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

Primary Purpose

Hyperlipidemia, Mixed Hyperlipidemia, Dyslipidemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Niacin Extended Release/Lovastatin
Sponsored by
In His Image
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring Hyperlipidemia, Dyslipidemia, Niacin, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Combination lipid therapy, Lovastatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: >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 Exclusion Criteria: pregnancy/lactating liver disease allergies to statin or niacin active peptic ulcer disease previous treatment with combination therapy for dyslipidemia

Sites / Locations

  • Family Medical Care of Tulsa

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 27, 2006
Last Updated
June 27, 2006
Sponsor
In His Image
Collaborators
Kos Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00345657
Brief Title
Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care
Official Title
Extended-Release Niacin/Lovastatin Versus Usual Care for Treatment of Dyslipidemia in a Primary Care Setting (EXTEND Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
In His Image
Collaborators
Kos Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Mixed Hyperlipidemia, Dyslipidemia
Keywords
Hyperlipidemia, Dyslipidemia, Niacin, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Combination lipid therapy, Lovastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Niacin Extended Release/Lovastatin
Primary Outcome Measure Information:
Title
Lipid parameter change at 3 and 6 months
Title
Percent of patients achieving ATP III LDL goals at 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >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 Exclusion Criteria: pregnancy/lactating liver disease allergies to statin or niacin active peptic ulcer disease previous treatment with combination therapy for dyslipidemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason A Logan, MD
Organizational Affiliation
In His Image Family Medicine Residency
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward Rylander, MD
Organizational Affiliation
In His Image Family Medicine Residency
Official's Role
Study Chair
Facility Information:
Facility Name
Family Medical Care of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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