MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

436 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2003-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Metabolic X Syndrome Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

MK0767; 2.5 mg/day

Group Type EXPERIMENTAL

MK0767

Intervention Type DRUG

MK0767 2.5, 5, and 10 mg/day supplied as tablets

2

MK0767; 5mg/day

Group Type EXPERIMENTAL

MK0767

Intervention Type DRUG

MK0767 2.5, 5, and 10 mg/day supplied as tablets

3

MK0767; 10 mg/day

Group Type EXPERIMENTAL

MK0767

Intervention Type DRUG

MK0767 2.5, 5, and 10 mg/day supplied as tablets

4

fenofibrate 200 mg

Group Type ACTIVE_COMPARATOR

Comparator: fenofibrate

Intervention Type DRUG

fenofibrate 200 mg supplied as capsules

5

Matching Placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo (unspecified)

Intervention Type DRUG

matching placebo will be supplied as tablets/capsules.

Interventions

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MK0767

MK0767 2.5, 5, and 10 mg/day supplied as tablets

Intervention Type DRUG

Comparator: fenofibrate

fenofibrate 200 mg supplied as capsules

Intervention Type DRUG

Comparator: Placebo (unspecified)

matching placebo will be supplied as tablets/capsules.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No