drugset / Trial / NCT00203476
A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
Phase 4
Completed
30 enrolled
Tuscaloosa Research & Education Advancement Corporation
American Society of Health-System Pharmacists Research and Education Foundation · collab
RandomizedParallel-groupOpen-labelTreatment
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 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.
Timeline
- Start
- 2005-05
- Primary completion
- 2008-01
- Completion
- 2008-01
Publications
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Colestipol | Unknown | 20 g | — |
| Comparator | Ezetimibe | Unknown | 10 mg | — |
| Comparator | Niacin | Small molecule | 1500 mg | — |