Hypercholesterolemia, Hyperlipidemia
Conditions
Keywords
Primary Hypercholesterolemia or Mixed Hyperlipidemia
Brief summary
This is a 16-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the tolerability of MK0524A versus niacin extended-release. There will be 6 scheduled clinic visits and 2 treatment groups.
Interventions
Duration of Treatment: 18 Weeks
DRUGniacin
Duration of Treatment: 18 Weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient is an appropriate candidate for niacin therapy (at risk for heart disease) and triglycerides \< 500 mg/dL
Exclusion criteria
* Patients with a history of any cardiovascular event directly linked to atherosclerosis with a low density lipoprotein-cholesterol (LDL-C) \>/= 130 mg/dL and/or not on a statin * Patients with diabetes and LDL-C \>/= 130 mg/dL. Patients with \>/= 2 heart disease risk factors and LDL-C \>/= 160 mg/dL. * Patients who have had a cardiovascular event (e.g., heart attack, stroke) within the previous 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Flushing Severity Score (GFSS) over 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety/tolerability | — |
Outcome results
None listed