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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00679055
Other study ID # 0736-006
Secondary ID 2007_600
Status Terminated
Phase Phase 1
First received
Last updated
Start date March 31, 2007
Est. completion date August 26, 2008

Study information

Verified date July 2018
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date August 26, 2008
Est. primary completion date August 26, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Intervention

Drug:
MK-0736
MK-0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks.
Comparator: placebo (unspecified)
Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp. FoxHollow Technologies

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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