MK0767 in Metabolic Syndrome-Dyslipidemia - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00703690

Purpose

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

Condition	Intervention	Phase
Metabolic X Syndrome Dyslipidemia	Drug: MK0767 Drug: Comparator: fenofibrate Drug: Comparator: Placebo (unspecified)	Phase II

MedlinePlus related topics: Metabolic Syndrome

Drug Information available for: Procetofen Lipids

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride. [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MK0767 will be safe and well tolerated [ Time Frame: throughout study and at 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	198
Study Start Date:	January 2002
Primary Completion Date:	October 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MK0767; 2.5 mg/day	Drug: MK0767 MK0767 2.5, 5, and 10 mg/day supplied as tablets
2: Experimental MK0767; 5mg/day	Drug: MK0767 MK0767 2.5, 5, and 10 mg/day supplied as tablets
3: Experimental MK0767; 10 mg/day	Drug: MK0767 MK0767 2.5, 5, and 10 mg/day supplied as tablets
4: Active Comparator fenofibrate 200 mg	Drug: Comparator: fenofibrate fenofibrate 200 mg supplied as capsules
5: Placebo Comparator Matching Placebo	Drug: Comparator: Placebo (unspecified) matching placebo will be supplied as tablets/capsules.

Eligibility

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703690

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_641, MK0767-016
Study First Received:	June 20, 2008
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00703690
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hyperinsulinism
Metabolic Diseases
Metabolic Syndrome X
Syndrome X
Insulin Resistance
Metabolic disorder

Glucose Metabolism Disorders
Procetofen
Abdominal obesity metabolic syndrome
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Antilipemic Agents
Syndrome
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009