MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016) | NCT00703690

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

NCT00703690

Sponsor

Merck Sharp & Dohme LLC

Status

Terminated

Last Update Posted

Jun 12, 2015Estimated

Enrollment

436Actual

Phase

Phase 2

Conditions

Metabolic X Syndrome Dyslipidemia

Interventions

MK0767
Comparator: fenofibrate
Comparator: Placebo (unspecified)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Dec 2003Actual

Completion Date

Dec 2003Actual

First Submitted Date

Jun 20, 2008

First Submission Date that Met QC Criteria

Jun 20, 2008

First Posted Date

Jun 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2015

Last Update Posted Date

Jun 12, 2015Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

436Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
MK0767	Drug	MK0767 2.5, 5, and 10 mg/day supplied as tablets	1 2 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride.		After 12 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
MK0767 will be safe and well tolerated		throughout study and at 12 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Type	Description	Link
MK0767-016
2007_641