NCT00570752已完成2 期
A 12-Week, Randomized, Semi Double-Blinded Study Evaluating the Effects of Daily Oral High-Dose Atorvastatin or BMS-582949 on Atherosclerotic Plaque Inflammation as Determined by FDG-PET in High Risk Atherosclerotic Patients
Bristol-Myers Squibb16 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 16
- 主要终点
- FDG-PET signal of the carotid and/or ascending aorta
研究概览
简要总结
The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation in atherosclerotic plaque
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of documented atherosclerosis
- •LDL between 70 and 130 mg/dL
- •Patients receiving stable low- to moderate-dose statin
- •BMI 18-37 kg/m²
- •Must be able to swallow tablets
- •Must be able to medically tolerate the procedures, contrast medium, and medications involved
排除标准
- •Statin intolerance
- •Renal impairment (serum creatinine > 1.5 mg/dL)
- •History of chronic viral hepatitis or other liver dysfunction
- •Major infection requiring hospitalization or receipt of IV antibiotics due to an infection within 2 months prior to initiation of study treatment
研究组 & 干预措施
Placebo + background low to moderate dose statin
Active Comparator
Placebo + background low to moderate dose statin Tablets, Oral, 0 mg, once daily, for 12 weeks
干预措施: Placebo (Other)
Placebo + background low to moderate dose statin
Active Comparator
Placebo + background low to moderate dose statin Tablets, Oral, 0 mg, once daily, for 12 weeks
干预措施: Statin (Drug)
BMS-582949 + Background low to moderate dose statin
Experimental
BMS-582949 + Background low to moderate dose statin Tablets, Oral, 100 mg, once daily for 12 weeks
干预措施: BMS-582949 (Drug)
BMS-582949 + Background low to moderate dose statin
Experimental
BMS-582949 + Background low to moderate dose statin Tablets, Oral, 100 mg, once daily for 12 weeks
干预措施: Statin (Drug)
Atorvastatin
Active Comparator
Atorvastatin Tablets, oral, 80 mg once daily for 12 weeks
干预措施: Atorvastatin (Drug)
结局指标
主要结局
FDG-PET signal of the carotid and/or ascending aorta
时间窗: at 4 and 12 weeks
次要结局
- Inflammatory and thrombotic biomarkers(will be measured throughout the 12 weeks of treatment)
研究者
研究点 (16)
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