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MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)

Primary Purpose

Metabolic X Syndrome Dyslipidemia

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

MK0767

Comparator: fenofibrate

Comparator: Placebo (unspecified)

About this trial

This is an interventional treatment trial for Metabolic X Syndrome Dyslipidemia

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm Description

MK0767; 2.5 mg/day

MK0767; 5mg/day

MK0767; 10 mg/day

fenofibrate 200 mg

Matching Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

MK0767 will be safe and well tolerated

Full Information

NCT ID

NCT00703690

First Posted

June 20, 2008

Last Updated

June 11, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00703690

Brief Title

MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)

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 Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Terminated

Study Start Date

January 2002 (undefined)

Primary Completion Date

December 2003 (Actual)

Study Completion Date

December 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic X Syndrome Dyslipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

436 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

MK0767; 2.5 mg/day

Arm Title

Arm Type

Experimental

Arm Description

MK0767; 5mg/day

Arm Title

Arm Type

Experimental

Arm Description

MK0767; 10 mg/day

Arm Title

Arm Type

Active Comparator

Arm Description

fenofibrate 200 mg

Arm Title

Arm Type

Placebo Comparator

Arm Description

Matching Placebo

Intervention Type

Drug

Intervention Name(s)

MK0767

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Comparator: fenofibrate

Intervention Description

fenofibrate 200 mg supplied as capsules

Intervention Type

Drug

Intervention Name(s)

Comparator: Placebo (unspecified)

Intervention Description

matching placebo will be supplied as tablets/capsules.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

MK0767 will be safe and well tolerated

Time Frame

throughout study and at 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)

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