- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00203476
A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
August 8, 2014 updated by: Raela Williford, PharmD, Tuscaloosa Research & Education Advancement Corporation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
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Tuscaloosa, Alabama, United States, 35404
- Tuscaloosa Research & Education Advancement Corporation
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Statin with Niacin
Niacin dose range of 500-1500mg (average 888mg)
|
|
Active Comparator: Statin with Colestipol
Colestipol dose range 5-15gm (average 9.5gm)
|
|
Active Comparator: Statin with Ezitimibe
Ezitimibe 10mg (average 10mg)
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LDL Goal Attainment
Time Frame: 12 weeks
|
Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
LFT Elevation
Time Frame: 12 weeks
|
12 weeks
|
Incidents of Rhabdomyolysis
Time Frame: 12 weeks
|
12 weeks
|
Change in HDL From Baseline to 12 Weeks.
Time Frame: baseline and 12 weeks
|
baseline and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Raela B Williford, PharmD, Tuscaloosa Veterans Affairs Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
August 12, 2014
Last Update Submitted That Met QC Criteria
August 8, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Dyslipidemias
- Hypercholesterolemia
- Hyperlipidemias
- Hyperlipoproteinemias
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Antimetabolites
- Micronutrients
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Vitamins
- Vitamin B Complex
- Sequestering Agents
- Niacin
- Ezetimibe
- Colestipol
Other Study ID Numbers
- TREAC Cholesterol Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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