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

Phase 1TerminatedNCT00679055

Merck Sharp & Dohme LLC14 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Peripheral Vascular Diseases

Interventions

MK-0736DRUG

MK-0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks.

Comparator: placebo (unspecified)DRUG

Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Week 12

Secondary Outcomes

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.

Time frame: 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.

Time frame: up to 14 weeks

Data from ClinicalTrials.gov

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