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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00345657
Recruitment Status : Completed
First Posted : June 28, 2006
Last Update Posted : June 28, 2006
Sponsor:
Collaborator:
Kos Pharmaceuticals
Information provided by:
In His Image

Tracking Information
First Submitted Date  ICMJE June 27, 2006
First Posted Date  ICMJE June 28, 2006
Last Update Posted Date June 28, 2006
Study Start Date  ICMJE July 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2006)
  • Lipid parameter change at 3 and 6 months
  • Percent of patients achieving ATP III LDL goals at 3 and 6 months
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care
Official Title  ICMJE Extended-Release Niacin/Lovastatin Versus Usual Care for Treatment of Dyslipidemia in a Primary Care Setting (EXTEND Study)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperlipidemia
  • Mixed Hyperlipidemia
  • Dyslipidemia
Intervention  ICMJE Drug: Niacin Extended Release/Lovastatin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 27, 2006)
100
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE May 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00345657
Other Study ID Numbers  ICMJE IHI-A001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE In His Image
Collaborators  ICMJE Kos Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Jason A Logan, MD In His Image Family Medicine Residency
Study Chair: Edward Rylander, MD In His Image Family Medicine Residency
PRS Account In His Image
Verification Date June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP