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OpenTrials
Completed

NCT Number: NCT00203476

A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction

To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis. High-density lipoproteins (HDL) elevations are monitored between the three groups to determine efficacy as a secondary outcome.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tuscaloosa Research & Education Advancement Corporation

Tuscaloosa, Alabama, 35404, United States

About this study

: Patients with hyperlipidemia who sign consent and who are currently at maximum tolerated dose of a statin and are not meeting NCEP ATPIII treatment goals for LDL cholesterol are enrolled in 12-week open label, prospective trial. Patients are randomized into one of three groups to receive ezetimibe, niacin, or colestipol in addition to current statin therapy. Patients are titrated as tolerated to therapeutic doses of study medications (ezetimibe 10mg/day, niacin 1500mg/day, and colestipol 20gm/day). At baseline, informed consent; a laboratory admission profile (Chem20); weight; height; blood pressure; concomitant medications; cholesterol medication history; and grapefruit juice consumption data are gathered. At weeks 6 and 12, patients have their cholesterol panels and liver function tests assessed. Patients are also interviewed regarding side effects (including rhabdomyolysis), tolerance, changes in concomitant medications, and grapefruit juice consumption, along with weight and blood pressure measurements.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Veterans eligible for treatment at the Tuscaloosa VA Medical Center
  • 50 years of age
  • Male or female
  • Any race or ethnic group
  • Signed informed consent
  • Hyperlipidemia despite current maximum tolerated dose of an HMG CoA Reductase inhibitor (statin) for > 6 weeks
  • Currently not meeting NCEP ATPIII treatment goals for LDL cholesterol

Exclusion criteria

  • Known hypersensitivity or intolerance to ezetimibe, niacin, or colestipol
  • Previous failed adequate trial of adjunctive ezetimibe, niacin, or colestipol
  • Consumes more than 8oz. grapefruit juice daily
  • Significant medical condition that would impact safety evaluations (i.e. significantly elevated LFT, hepatitis, severe dermatitis, uncontrolled diabetes, severe GI disease, fibromyalgia, renal failure, recent CVA or MI, pancreatitis, etc.)
  • Receiving medications that would be contraindicated to use in combination with ezetimibe, niacin, or colestipol

Treatment and study plan

niacin

Drug

Colestipol

Drug

ezetimibe

Drug

Other names: Zetia

Primary outcomes

  1. LDL Goal Attainment

    Time frame: 12 weeks

    Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.

Secondary outcomes

  1. LFT Elevation

    Time frame: 12 weeks

  2. Incidents of Rhabdomyolysis

    Time frame: 12 weeks

  3. Change in HDL From Baseline to 12 Weeks.

    Time frame: baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

Tuscaloosa Research & Education Advancement Corporation

Other

Collaborators

  • American Society of Health-System Pharmacists Research and Education Foundation

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Aug 12, 2014

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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