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

Phase 3

Completed

• Conditions: Hypercholesterolemia; Hyperlipidemia
• Interventions: Drug: laropiprant/niacin (MK0524A)

• Registration Number: NCT00536510
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-09-26
• Study First Submitted QC: 2007-09-26
• Study First Posted: 2007-09-27
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2009-02-13
• Results First Submitted QC: 2009-03-27
• Results First Posted: 2009-05-13
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-01
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 646

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	laropiprant/niacin (MK0524A)	laropiprant/niacin (MK0524A)

Primary Outcome Measures

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

Secondary Outcome Measures

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