A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction

Completed · Phase 4

Conditions studied: Hyperlipidemia, Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT00203476

Run by

Tuscaloosa Research & Education Advancement Corporation

People needed

30

Starts

2005-05-01

Expected to finish

2008-01-01

Last updated by the study team

2014-08-12

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tuscaloosa Research & Education Advancement Corporation — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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