A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hyperlipidemia Hypercholesterolemia |
Drug: ezetimibe Drug: niacin Drug: colestipol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 i
- . 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.
| Estimated Enrollment: | 90 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | May 2008 |
: 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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| 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| United States, Alabama | |
| Tuscaloosa Research & Education Advancement Corporation | Recruiting |
| Tuscaloosa, Alabama, United States, 35404 | |
| Contact: Raela B Williford, PharmD 205-554-2000 ext 2733 Raela.Williford@va.gov | |
| Principal Investigator: Raela B Williford, PharmD | |
| Principal Investigator: | Raela B Williford, PharmD | Tuscaloosa VA Medical Center |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00203476 History of Changes |
| Other Study ID Numbers: | TREAC Cholesterol Study, TREAC Cholesterol Study |
| Study First Received: | September 12, 2005 |
| Last Updated: | March 16, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Tuscaloosa Research & Education Advancement Corporation:
|
ezetimibe niacin colestipol |
hyperlipidemia adjunct therapy zetia |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Colestipol Niacin Ezetimibe Nicotinic Acids Niacinamide Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Vasodilator Agents Cardiovascular Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Anticholesteremic Agents |
ClinicalTrials.gov processed this record on May 22, 2013