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Completed

NCT Number: NCT00345657

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

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.

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Key information

Conditions

Hyperlipidemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemia Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Mixed Hyperlipidemia Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Family Medical Care of Tulsa

Tulsa, Oklahoma, 74136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years old with CAD or risk factors for CAD
  • under standard care at Family Medical Care of Tulsa
  • not at LDL goal per ATP III guidelines

Exclusion criteria

  • pregnancy/lactating
  • liver disease
  • allergies to statin or niacin
  • active peptic ulcer disease
  • previous treatment with combination therapy for dyslipidemia

Treatment and study plan

Niacin Extended Release/Lovastatin

Drug

Primary outcomes

  1. Lipid parameter change at 3 and 6 months

  2. Percent of patients achieving ATP III LDL goals at 3 and 6 months

Sponsors and collaborators

Lead sponsor

In His Image

Other

Collaborators

  • Kos Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Jun 28, 2006
Registry last updated
Jun 28, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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