Status:
COMPLETED
A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
Lead Sponsor:
Tuscaloosa Research & Education Advancement Corporation
Collaborating Sponsors:
American Society of Health-System Pharmacists Research and Education Foundation
Conditions:
Hyperlipidemia
Hypercholesterolemia
Eligibility:
All Genders
50+ years
Phase:
PHASE4
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 patien...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00203476
Start Date
May 1 2005
End Date
January 1 2008
Last Update
August 12 2014
Active Locations (1)
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1
Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa, Alabama, United States, 35404