A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
This study has been completed.
Sponsor:
Tuscaloosa Research & Education Advancement Corporation
Collaborator:
American Society of Health-System Pharmacists Research and Education Foundation
Information provided by (Responsible Party):
Raela Williford, PharmD, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier:
NCT00203476
First received: September 12, 2005
Last updated: August 8, 2014
Last verified: August 2014
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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: Niacin Drug: Colestipol Drug: Ezetimibe |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel 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 |
Resource links provided by NLM:
Further study details as provided by Tuscaloosa Research & Education Advancement Corporation:
Primary Outcome Measures:
- LDL Goal Attainment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.
Secondary Outcome Measures:
- LFT Elevation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Incidents of Rhabdomyolysis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in HDL From Baseline to 12 Weeks. [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 30 |
| Study Start Date: | May 2005 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00203476
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203476
Locations
| 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
Investigators
| Principal Investigator: | Raela B Williford, PharmD | Tuscaloosa VA Medical Center |
More Information
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 |
| Study First Received: | September 12, 2005 |
| Results First Received: | December 5, 2013 |
| Last Updated: | August 8, 2014 |
| 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 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 |
ClinicalTrials.gov processed this record on September 30, 2016