Phase 3
N=646
Effect of MK0524A on Cholesterol Levels (0524A-048)
Hypercholesterolemia · Hyperlipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00536510 ↗Enrolled (actual)
646
Serious AEs
0.8%
Results posted
May 2009
Primary outcome: Primary: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks — -10.3; 4.4 Percent Change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- laropiprant/niacin (MK0524A) (Drug); Comparator: placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks |
-10.3; 4.4 | <0.001 sig |
| SECONDARY Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks |
18.6; 2.6 | <0.001 sig |
Summary
The primary objective of the study is to assess the effects of MK0524A in reducing cholesterol levels in an Asian population.
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
Data sourced from ClinicalTrials.gov (NCT00536510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.