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

NCT01335997 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1139

Last updated 2019-02-06

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-01
Primary Completion
2012-01-01
Completion
2012-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01335997 on ClinicalTrials.gov