NCT00536510CompletedPhase 3
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 646
- Primary Endpoint
- Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks
Study Overview
Brief Summary
The primary objective of the study is to assess the effects of MK0524A in reducing cholesterol levels in an Asian population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
laropiprant/niacin (MK0524A)
Intervention: laropiprant/niacin (MK0524A) (Drug)
Outcomes
Primary Outcomes
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks
Time Frame: 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 Outcomes
- Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks(12 weeks)
Investigators
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