Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 1:07 PM
Study NCT ID:
NCT00345657
Status:
COMPLETED
Last Update Posted:
2006-06-28
First Post:
2006-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care
Sponsor:
In His Image
Organization:
Study Overview
Official Title:
Extended-Release Niacin/Lovastatin Versus Usual Care for Treatment of Dyslipidemia in a Primary Care Setting (EXTEND Study)
Status:
COMPLETED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: