Effect of MK0524A on Cholesterol Levels (0524A-048)

Merck Sharp & Dohme LLC646 enrolled

Overview

The primary objective of the study is to assess the effects of MK0524A in reducing cholesterol levels in an Asian population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

646

Conditions

Hypercholesterolemia Hyperlipidemia

Interventions

laropiprant/niacin (MK0524A)DRUG

Treatment Period 1: one 20mg/1g tablet laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization

Comparator: placeboDRUG

Treatment Period 1: one 20mg/1g tablet placebo to laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets of placebo to laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is male or female between 18 and 70 years of age * Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study Exclusion Criteria: * Patient has a history of not being able to take niacin or niacin-containing products * Patient consumes more than 2 alcoholic beverages per day * Patient has poorly controlled Type 1 or Type 2 diabetes mellitus * Patient engages in vigorous exercise or an aggressive diet regimen

Outcomes

Primary Outcomes

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks

Low Density Lipoprotein Cholesterol (LDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure \*100

Time frame: 12 weeks

Secondary Outcomes

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks

Percent change from baseline in High Density Lipoprotein Cholesterol (HDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure \*100

Time frame: 12 weeks

Data from ClinicalTrials.gov

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