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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

Page last updated: August 23, 2015

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