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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
GroupInterventionDescription
2MK0767MK0767; 5mg/day
3MK0767MK0767; 10 mg/day
1MK0767MK0767; 2.5 mg/day
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
MK0767 will be safe and well toleratedthroughout study and at 12 weeks
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