A Study of How MK-0736 Affects Arterial Plaque (0736-006)(TERMINATED)
|ClinicalTrials.gov Identifier: NCT00679055|
Recruitment Status : Terminated (Lack of recruitment)
First Posted : May 16, 2008
Results First Posted : February 16, 2015
Last Update Posted : May 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vascular Diseases||Drug: MK-0736 Drug: Comparator: placebo (unspecified)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||March 31, 2007|
|Primary Completion Date :||August 26, 2008|
|Study Completion Date :||August 26, 2008|
Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks
Drug: Comparator: placebo (unspecified)
Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.
Placebo Comparator: Placebo
Participants will be orally administered placebo once daily for 12 weeks.
MK-0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks.
- Change From Baseline in Cluster of Differentiation 68 (CD68) [ Time Frame: 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.
- Change From Baseline in Messenger Ribonucleic Acid (mRNA) [ Time Frame: 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) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679055
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|