drugset / Trial / NCT01335997
Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
RandomizedCrossoverDouble-blindTreatment
Summary
This study is being done to find out if tablets containing extended release (ER) niacin, laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high cholesterol and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM 2 g /20 mg is equivalent to ERN/LRPT 2 g coadministered with simvastatin 20 mg in reducing low-density lipoprotein cholestrol (LDL-C).
Timeline
- Start
- 2011-05-01
- Primary completion
- 2012-01-01
- Completion
- 2012-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Niacin | Small molecule | 2 g | Oral |
| Subject | Simvastatin | Small molecule | 20 mg | Oral |
| Subject | laropiprant | Small molecule | 20 mg | Oral |