MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic X Syndrome Dyslipidemia
Intervention: MK0767 (Drug); Comparator: fenofibrate (Drug); Comparator: Placebo (unspecified) (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
This is a clinical trial in patients with Metabolic Syndrome and Dyslipidemia to study the
effects of MK0767 on triglycerides.
Clinical Details
Official title: A Multicenter, Double-Blind, Randomized, Placebo and Active-Controlled, Parallel Study to Evaluate the Lipid Altering Efficacy and Safety of MK0767 in Patients With Metabolic Syndrome and Dyslipidemia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride.
Secondary outcome: MK0767 will be safe and well tolerated
Eligibility
Minimum age: 21 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: January 2002
Last updated: June 11, 2015
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