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)

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 977 (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/40 mg is equivalent to ERN/LRPT 2 g co-administered with simvastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C).

Conditions

• Primary Hypercholesterolemia
• Dyslipidemia

Interventions

Type	Name	Description
DRUG	Simvastatin
DRUG	Extended Release (ER) niacin/laropiprant/simvastatin (N/LRPT/SIM)
DRUG	Extended Release (ER) niacin/laropiprant (N/LRPT)
DRUG	Placebo

Timeline

• Start date: 2011-02-04
• Primary completion: 2012-01-17
• Completion: 2012-01-17
• First posted: 2011-02-11
• Last updated: 2018-08-16
• Results posted: 2016-12-13