Back to resultsEffect of MK0524A on Cholesterol Levels (0524A-048)
Primary Purpose
Hypercholesterolemia, Hyperlipidemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
laropiprant/niacin (MK0524A)
Comparator: placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring High Cholesterol, Excess lipids
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
laropiprant/niacin (MK0524A)
placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00536510
First Posted
September 26, 2007
Last Updated
September 1, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00536510
Brief Title
Effect of MK0524A on Cholesterol Levels (0524A-048)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
The primary objective of the study is to assess the effects of MK0524A in reducing cholesterol levels in an Asian population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Hyperlipidemia
Keywords
High Cholesterol, Excess lipids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
646 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
laropiprant/niacin (MK0524A)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
laropiprant/niacin (MK0524A)
Other Intervention Name(s)
MK0524A
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks
Description
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 Outcome Measure Information:
Title
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21291812
Citation
Kush D, Kim HS, Hu DY, Liu J, Sirah W, Sapre A, McCrary Sisk C, Paolini JF, Maccubbin D. Lipid-modifying efficacy of extended release niacin/laropiprant in Asian patients with primary hypercholesterolemia or mixed hyperlipidemia. J Clin Lipidol. 2009 May-Jun;3(3):179-86. doi: 10.1016/j.jacl.2009.04.048. Epub 2009 May 3.
Results Reference
result
Learn more about this trial
Effect of MK0524A on Cholesterol Levels (0524A-048)
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