A Study of How MK-0736 Affects Arterial Plaque (0736-006)(TERMINATED)

Study Overview
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Brief Summary
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A 12-Week Efficacy Study in participants with Peripheral Arterial Disease. the primary hypothesis is that MK-0736 7 mg administered once daily for 12 weeks will result in a decrease in lower extremity atherosclerotic plaque macrophage content when compared to placebo (an approximate decrease of up to 30% is expected).

Official Title
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An Exploratory Double-Blind, Placebo Controlled, Randomized, 12-Week Oral Dose Study to Evaluate the Effects of MK0736 on Atherosclerotic Disease Biomarkers in Lower Extremity Plaque Excised From Patients With Peripheral Arterial Disease

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Drug: MK-0736
* Drug: Comparator: placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with peripheral arterial disease Participants must be 18 to 85 years of age Females must be postmenopausal or sterile Exclusion Criteria: Participans with hepatic, HIV, endocrine, connective tissue, psychiatric disorders or uncontrolled hypertension

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-0736<br>Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks | Drug: Comparator: placebo (unspecified)<br>* Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.<br>|
| Placebo Comparator: Placebo<br>Participants will be orally administered placebo once daily for 12 weeks. | Drug: MK-0736<br>* MK-0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Cluster of Differentiation 68 (CD68) | CD68 is a heavily glycosylated transmembrane protein resident to macrophage lysosomes, and is the standard immunohistochemical (IHC) marker for macrophages in human tissues. CD68 protein content as a measure of macrophage number is the most often reported marker in clinical studies of plaque instability. Blood samples were taken to determine the level of CD69 present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Messenger Ribonucleic Acid (mRNA) | mRNA is a biomarker associated with the inflammatory response. Blood samples were taken to determine the level of mRNA present at baseline (predose Day 1) and again after 12 weeks of study drug administration in participants with peripheral arterial disease of the lower extremity who are scheduled for excision of an atherosclerotic plaque. | Baseline and Week 12 | 
| Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE) | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. The percentage of participants who were discontinued from the study due to an AE was summarized. | up to 14 weeks |