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

This study has been completed.
Sponsor:
Collaborator:
Kos Pharmaceuticals
Information provided by:
In His Image
ClinicalTrials.gov Identifier:
NCT00345657
First received: June 27, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00345657     History of Changes
Other Study ID Numbers: IHI-A001
Study First Received: June 27, 2006
Last Updated: June 27, 2006
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Dyslipidemias
Hyperlipidemias
Hyperlipidemia, Familial Combined
Hyperlipoproteinemia Type V
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Hypertriglyceridemia
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Lovastatin
Niacin
Nicotinic Acids
Niacinamide
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on October 19, 2014