MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Metabolic X Syndrome Dyslipidemia

Treatments: Drug: Comparator: fenofibrate; Drug: MK0767; Drug: Comparator: Placebo (unspecified)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00703690

MK0767-016

0767-016

2007_641

Details and patient eligibility

About

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

Enrollment: 436 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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436 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

MK0767; 2.5 mg/day

Treatment:

Drug: MK0767

2

Experimental group

Description:

MK0767; 5mg/day

Treatment:

Drug: MK0767

3

Experimental group

Description:

MK0767; 10 mg/day

Treatment:

Drug: MK0767

4

Active Comparator group

Description:

fenofibrate 200 mg

Treatment:

Drug: Comparator: fenofibrate

5

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: Comparator: Placebo (unspecified)