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

Phase 1

Terminated

• Conditions: Peripheral Vascular Diseases
• Interventions: Drug: MK-0736

• Registration Number: NCT00679055
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-31
• Study First Submitted: 2008-05-14
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-16
• Primary Completion: 2008-08-26
• Study Completion: 2008-08-26
• Results First Submitted: 2015-01-30
• Results First Submitted QC: 2015-01-30
• Results First Posted: 2015-02-16
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-20
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Participants with peripheral arterial disease
• Participants must be 18 to 85 years of age
• Females must be postmenopausal or sterile

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Exclusion Criteria

• Participans with hepatic, HIV, endocrine, connective tissue, psychiatric disorders or uncontrolled hypertension

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	MK-0736	Participants will be orally administered placebo once daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Cluster of Differentiation 68 (CD68)	Baseline and Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Messenger Ribonucleic Acid (mRNA)	Baseline and Week 12	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.
Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE)	up to 14 weeks	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.