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

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ClinicalTrials.gov Identifier: NCT00203476
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : August 12, 2014
Last Update Posted : August 12, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Hypercholesterolemia Drug: Niacin Drug: Colestipol Drug: Ezetimibe Phase 4

Detailed Description:
: 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
Study Start Date : May 2005
Primary Completion Date : January 2008
Study Completion Date : January 2008

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Statin with Niacin
Niacin dose range of 500-1500mg (average 888mg)
Drug: Niacin
Active Comparator: Statin with Colestipol
Colestipol dose range 5-15gm (average 9.5gm)
Drug: Colestipol
Active Comparator: Statin with Ezitimibe
Ezitimibe 10mg (average 10mg)
Drug: Ezetimibe
Other Name: Zetia

Outcome Measures

Primary Outcome Measures :
  1. LDL Goal Attainment [ Time Frame: 12 weeks ]
    Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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): NCT00203476

United States, Alabama
Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa, Alabama, United States, 35404
Sponsors and Collaborators
Tuscaloosa Research & Education Advancement Corporation
American Society of Health-System Pharmacists Research and Education Foundation
Principal Investigator: Raela B Williford, PharmD Tuscaloosa VA Medical Center
More Information

Responsible Party: Raela Williford, PharmD, Clinical Pharmacist/PI, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT00203476     History of Changes
Other Study ID Numbers: TREAC Cholesterol Study
First Posted: September 20, 2005    Key Record Dates
Results First Posted: August 12, 2014
Last Update Posted: August 12, 2014
Last Verified: August 2014

Keywords provided by Raela Williford, PharmD, Tuscaloosa Research & Education Advancement Corporation:
adjunct therapy

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Nicotinic Acids
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Sequestering Agents