MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)
Phase 2
Terminated
- Conditions
- Metabolic X Syndrome Dyslipidemia
- Interventions
- Drug: MK0767
- Registration Number
- NCT00703690
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is a clinical trial in patients with Metabolic Syndrome and Dyslipidemia to study the effects of MK0767 on triglycerides.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 436
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 MK0767 MK0767; 5mg/day 3 MK0767 MK0767; 10 mg/day 1 MK0767 MK0767; 2.5 mg/day
- Primary Outcome Measures
Name Time Method a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride. After 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method MK0767 will be safe and well tolerated throughout study and at 12 weeks