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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345657
First Posted: June 28, 2006
Last Update Posted: July 4, 2006
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.
Collaborator:
Kos Pharmaceuticals
Information provided by:
In His Image
  Purpose
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.

Condition Intervention Phase
Hyperlipidemia Mixed Hyperlipidemia Dyslipidemia Drug: Niacin Extended Release/Lovastatin Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extended-Release Niacin/Lovastatin Versus Usual Care for Treatment of Dyslipidemia in a Primary Care Setting (EXTEND Study)

Resource links provided by NLM:


Further study details as provided by In His Image:

Primary Outcome Measures:
  • Lipid parameter change at 3 and 6 months
  • Percent of patients achieving ATP III LDL goals at 3 and 6 months

Estimated Enrollment: 100
Study Start Date: July 2003
Estimated Study Completion Date: May 2004
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345657


Locations
United States, Oklahoma
Family Medical Care of Tulsa
Tulsa, Oklahoma, United States, 74136
Sponsors and Collaborators
In His Image
Kos Pharmaceuticals
Investigators
Principal Investigator: Jason A Logan, MD In His Image Family Medicine Residency
Study Chair: Edward Rylander, MD In His Image Family Medicine Residency
  More Information

ClinicalTrials.gov Identifier: NCT00345657     History of Changes
Other Study ID Numbers: IHI-A001
First Submitted: June 27, 2006
First Posted: June 28, 2006
Last Update Posted: July 4, 2006
Last Verified: June 2006

Keywords provided by In His Image:
Hyperlipidemia
Dyslipidemia
Niacin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Combination lipid therapy
Lovastatin

Additional relevant MeSH terms:
Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Hyperlipidemia, Familial Combined
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Niacin
Lovastatin
L 647318
Dihydromevinolin
Niacinamide
Nicotinic Acids
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anticholesteremic Agents
Enzyme Inhibitors