MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)

Metabolic X Syndrome Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00703690
• Other study ID #: 0767-016
• Secondary ID: MK0767-0162007_6
• Status: Terminated
• Phase: Phase 2
• First received: June 20, 2008
• Last updated: June 11, 2015
• Start date: January 2002
• Est. completion date: December 2003

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a clinical trial in patients with Metabolic Syndrome and Dyslipidemia to study the effects of MK0767 on triglycerides.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 436
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Metabolic Syndrome X
• Metabolic X Syndrome Dyslipidemia
• Syndrome

Intervention

Drug:
• MK0767
MK0767 2.5, 5, and 10 mg/day supplied as tablets
• Comparator: fenofibrate
fenofibrate 200 mg supplied as capsules
• Comparator: Placebo (unspecified)
matching placebo will be supplied as tablets/capsules.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride.		After 12 weeks of treatment	No
Secondary	MK0767 will be safe and well tolerated		throughout study and at 12 weeks	Yes