Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)

Merck Sharp & Dohme LLC1,216 enrolled

Overview

This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,216

Conditions

Primary Hypercholesterolemia Mixed Dyslipidemia

Interventions

Comparator: simvastatinDRUG

simvastatin (20mg to 40mg) for 12 weeks.

niacin (+) laropiprantDRUG

One tablet of ER niacin/ laropiprant (1g); titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.

Comparator: atorvastatin calciumDRUG

atorvastatin calcium (20mg to 40mg) for 12 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia * Patients will be eligible for the study if their LDL-C values are within protocol specified range and meet other entry criteria Exclusion Criteria: * Patient whose LDL-C values are not within protocol specified range

Outcomes

Primary Outcomes

Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12

Time frame: Baseline and 12 Weeks

Secondary Outcomes

Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12

Time frame: Baseline and 12 Weeks

Percent Change From Baseline in Triglycerides at Week 12

Time frame: Baseline and 12 Weeks

Data from ClinicalTrials.gov

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