Dyslipidemia
Conditions
Brief summary
This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy.
Interventions
DRUGanacetrapib
\[Intervention Name: MK0859\] MK0859 100 mg tablet once daily for 8 weeks.
Atorvastatin 20 mg tablet once daily for 4 weeks in Period 1 and 8 weeks in Period 2.
DRUGComparator: placebo to MK0859
Placebo to MK0859 once daily for 4 weeks.
DRUGComparator: placebo to atorvastatin
Placebo to atorvastatin once daily for 4 weeks in Period 1 and 8 weeks in Period 2.
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 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient's weight has been stable for at least 6 weeks * Patient is in good health based on medical history, physical exam, and laboratory tests * Patient has dyslipidemia
Exclusion criteria
: * Patient has a history of stroke, seizures, or major neurological disorders * Patient has a history of cancer * Patient is currently taking any lipid-lowering medications or substances except for statins * Patient consumes excessive amounts of alcohol or caffeine * Patient has multiple and/or severe allergies to food or drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo | 12 weeks |
Outcome results
None listed