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Trial record 22 of 23 for:    "Hyperinsulinism" | "Fenofibrate"

MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00703690
Recruitment Status : Terminated
First Posted : June 23, 2008
Last Update Posted : June 12, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Metabolic X Syndrome Dyslipidemia Drug: MK0767 Drug: Comparator: fenofibrate Drug: Comparator: Placebo (unspecified) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2002
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate

Arm Intervention/treatment
Experimental: 1
MK0767; 2.5 mg/day
Drug: MK0767
MK0767 2.5, 5, and 10 mg/day supplied as tablets

Experimental: 2
MK0767; 5mg/day
Drug: MK0767
MK0767 2.5, 5, and 10 mg/day supplied as tablets

Experimental: 3
MK0767; 10 mg/day
Drug: MK0767
MK0767 2.5, 5, and 10 mg/day supplied as tablets

Active Comparator: 4
fenofibrate 200 mg
Drug: Comparator: fenofibrate
fenofibrate 200 mg supplied as capsules

Placebo Comparator: 5
Matching Placebo
Drug: Comparator: Placebo (unspecified)
matching placebo will be supplied as tablets/capsules.

Primary Outcome Measures :
  1. a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride. [ Time Frame: After 12 weeks of treatment ]

Secondary Outcome Measures :
  1. MK0767 will be safe and well tolerated [ Time Frame: throughout study and at 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00703690

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00703690     History of Changes
Other Study ID Numbers: 0767-016
First Posted: June 23, 2008    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents