drugset / Trial / NCT01335997

Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)

NCT01335997

Phase 3 Terminated 1139 enrolled Merck Sharp & Dohme LLC
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

EvaluationDrugModalityDoseRoute
Subject Niacin Small molecule 2 g Oral
Subject Simvastatin Small molecule 20 mg Oral
Subject laropiprant Small molecule 20 mg Oral