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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 14
- 主要终点
- Change From Baseline in Cluster of Differentiation 68 (CD68)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with peripheral arterial disease
- •Participants must be 18 to 85 years of age
- •Females must be postmenopausal or sterile
排除标准
- •Participans with hepatic, HIV, endocrine, connective tissue, psychiatric disorders or uncontrolled hypertension
研究组 & 干预措施
Placebo
Participants will be orally administered placebo once daily for 12 weeks.
干预措施: MK-0736 (Drug)
结局指标
主要结局
Change From Baseline in Cluster of Differentiation 68 (CD68)
时间窗: 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.
次要结局
- Change From Baseline in Messenger Ribonucleic Acid (mRNA)(Baseline and Week 12)
- Number of Participants Who Were Discontinued From the Study Due to an Adverse Event (AE)(up to 14 weeks)