MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)(COMPLETED)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00703690
First received: June 20, 2008
Last updated: February 18, 2014
Last verified: February 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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: 436
Study Start Date: January 2002
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0767; 2.5 mg/day
Drug: MK0767
MK0767 2.5, 5, and 10 mg/day supplied as tablets
Other Name: MK0767
Experimental: 2
MK0767; 5mg/day
Drug: MK0767
MK0767 2.5, 5, and 10 mg/day supplied as tablets
Other Name: MK0767
Experimental: 3
MK0767; 10 mg/day
Drug: MK0767
MK0767 2.5, 5, and 10 mg/day supplied as tablets
Other Name: MK0767
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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00703690     History of Changes
Other Study ID Numbers: 0767-016, MK0767-016, 2007_641
Study First Received: June 20, 2008
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dyslipidemias
Metabolic Syndrome X
Lipid Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014