NCT00703690

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
436

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2002

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2008

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

1.9 years

First QC Date

June 20, 2008

Last Update Submit

June 11, 2015

Conditions

Metabolic X Syndrome Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride.

    After 12 weeks of treatment

Secondary Outcomes (1)

  • MK0767 will be safe and well tolerated

    throughout study and at 12 weeks

Study Arms (5)

1

EXPERIMENTAL

MK0767; 2.5 mg/day

Drug: MK0767

2

EXPERIMENTAL

MK0767; 5mg/day

Drug: MK0767

3

EXPERIMENTAL

MK0767; 10 mg/day

Drug: MK0767

4

ACTIVE COMPARATOR

fenofibrate 200 mg

Drug: Comparator: fenofibrate

5

PLACEBO COMPARATOR

Matching Placebo

Drug: Comparator: Placebo (unspecified)

Interventions

MK0767DRUG

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

123
Comparator: fenofibrateDRUG

fenofibrate 200 mg supplied as capsules

4
Comparator: Placebo (unspecified)DRUG

matching placebo will be supplied as tablets/capsules.

5

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

MK0767

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2008

First Posted

June 23, 2008

Study Start

January 1, 2002

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

June 12, 2015

Record last verified: 2015-06