NCT01335997

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

A Phase III Multicenter, Double-Blind, Crossover Design Study to Evaluate Lipid-Altering Efficacy and Safety of 1 g/10 mg Extended-Release Niacin/Laropiprant/Simvastatin Combination Tablets in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,139 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Primary Hypercholesterolemia
• Mixed Dyslipidemia

Interventions

Type	Name	Description
DRUG	ER niacin/laropiprant (ERN/LRPT)	ER niacin 1 g/laropiprant 20 mg oral tablet taken once daily
DRUG	ER niacin/laropiprant/simvastatin (ERN/LRPT/SIM)	ER niacin 1 g/laropiprant 20 mg/simvastatin 10 mg oral tablet taken once daily
DRUG	Simvastatin (SIM)	Simvastatin 10 mg oral tablet taken once daily
DRUG	Placebo Run-In	Placebo matches both ER niacin 1 g/laropiprant 20 mg oral tablet and ER niacin 1 g/laropiprant 20 mg/simvastatin 10 mg oral tablet; placebo is taken once daily
DRUG	SIM-matching placebo	Placebo for simvastatin 10 mg oral tablet taken once daily

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-04-15
• Last updated: 2019-02-06
• Results posted: 2016-06-21