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

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345657
• Other study ID #: IHI-A001
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2006
• Last updated: June 27, 2006
• Start date: July 2003
• Est. completion date: May 2004

Study information

• Verified date: June 2006
• Source: In His Image
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hyperlipidemia
• Hyperlipidemia, Familial Combined
• Hyperlipidemias
• Hyperlipoproteinemia Type V
• Mixed Hyperlipidemia

Intervention

Drug:
• Niacin Extended Release/Lovastatin

Locations

Country	Name	City	State
United States	Family Medical Care of Tulsa	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
In His Image	Kos Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid parameter change at 3 and 6 months
Primary	Percent of patients achieving ATP III LDL goals at 3 and 6 months