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

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

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Lipid-Altering Efficacy and Safety and Tolerability of MK0524A in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia

Conditions
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Hypercholesterolemia, Hyperlipidemia

Intervention / Treatment
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* Drug: laropiprant/niacin (MK0524A)
* Drug: Comparator: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>laropiprant/niacin (MK0524A) | Drug: laropiprant/niacin (MK0524A)<br>* 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<br>* Other names: MK0524A;|
| Placebo Comparator: 2<br>placebo | Drug: Comparator: placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Cholesterol, Excess lipids