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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyperlipidemia Hypercholesterolemia | Drug: Niacin Drug: Colestipol Drug: Ezetimibe | Phase 4 |
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 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | January 2008 |

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
|
- LDL Goal Attainment [ Time Frame: 12 weeks ]Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.
- LFT Elevation [ Time Frame: 12 weeks ]
- Incidents of Rhabdomyolysis [ Time Frame: 12 weeks ]
- Change in HDL From Baseline to 12 Weeks. [ Time Frame: baseline and 12 weeks ]

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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

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 |
Principal Investigator: | Raela B Williford, PharmD | Tuscaloosa VA Medical Center |
Publications:
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:
ezetimibe niacin colestipol |
hyperlipidemia adjunct therapy zetia |
Additional relevant MeSH terms:
Hypercholesterolemia Hyperlipidemias Hyperlipoproteinemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Ezetimibe Niacin Colestipol Niacinamide Nicotinic Acids Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vasodilator Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Sequestering Agents |