Metabolic X Syndrome Dyslipidemia
Conditions
Brief summary
This is a clinical trial in patients with Metabolic Syndrome and Dyslipidemia to study the effects of MK0767 on triglycerides.
Interventions
DRUGMK0767
MK0767 2.5, 5, and 10 mg/day supplied as tablets
DRUGComparator: fenofibrate
fenofibrate 200 mg supplied as capsules
DRUGComparator: Placebo (unspecified)
matching placebo will be supplied as tablets/capsules.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Metabolic Syndrome and Dyslipidemia age 21 to 65 * Patients will be eligible for the study if their triglyceride levels are within protocol specified range and have at least 2 of the criteria for Metabolic Syndrome as defined by NCEP
Exclusion criteria
* Patients with a history of diabetes mellitus, partial ileal bypass, intolerant to fibric acid derivatives, requiring continuous oral corticosteroids, taking anti-seizure medications, documented coronary heart disease, renal insufficiency, proteinuria, viral hepatitis, cholelithiasis or other gallbladder disease, pancreatitis, neoplastic disease * Patient is on cyclical estrogen medications * Patient has taken lipid-lowering agents including fibric acid derivatives, bile acid sequestrants, HMG CoA reductase inhibitors and nicotinic acid derivatives within 8 weeks or probucol within 1 year of prior to visit 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride. | After 12 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| MK0767 will be safe and well tolerated | throughout study and at 12 weeks |
Outcome results
None listed