drugset / Trial / NCT01294683
A Study to Evaluate Efficacy and Safety of Extended-Release Niacin + Laropiprant + Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118)
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/40 mg is equivalent to ERN/LRPT 2 g co-administered with simvastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C).
Timeline
- Start
- 2011-02-04
- Primary completion
- 2012-01-17
- Completion
- 2012-01-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Niacin | Small molecule | 1 g | — |
| Subject | Niacin | Small molecule | 2 g | — |
| Subject | Simvastatin | Small molecule | 20 mg | — |
| Subject | Simvastatin | Small molecule | 40 mg | — |
| Subject | laropiprant | Small molecule | 20 mg | — |