A Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of Two Regimens of GW856553, Over a Period of 3 Month, on In-vivo Macrophage Activity, as Assessed by FDG-PET/CT Imaging, in the Carotid Arteries and Aorta of Subjects With Established Atherosclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Change From Baseline of Mean of Maximum Tissue to Background Ratio (TBR) in the Qualifying Artery, Following 12 Weeks of Treatment in the Setting of Chronic Statin Therapy
研究概览
简要总结
This study is being conducted to assess the potential anti-inflammatory effects of a 3-month treatment with GW856553, on the inflammatory activity within the aorta and carotid plaques, as assessed by FDG-PET/CT.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LOSMAPIMOD 7.5 MG TWICE DAILY
Participants received 1 tablet of 7.5 mg Losmapimod orally twice daily, each morning and evening for a period of 12 weeks
干预措施: LOSMAPIMOD 7.5 MG (Drug)
Placebo
Participants received 1 tablet of placebo matching Losmapimod orally twice daily, each morning and evening for a period of 12 weeks.
干预措施: Placebo (Drug)
LOSMAPIMOD 7.5 MG ONCE DAILY
Participants received 1 tablet of 7.5 mg Losmapimod each morning once daily and placebo tablet each evening once daily orally for a period of 12 weeks.
干预措施: LOSMAPIMOD 7.5 MG (Drug)
结局指标
主要结局
Change From Baseline of Mean of Maximum Tissue to Background Ratio (TBR) in the Qualifying Artery, Following 12 Weeks of Treatment in the Setting of Chronic Statin Therapy
时间窗: Baseline (Days -14 to -1) and up to Week 12
Qualifying artery was defined as the artery (left or right carotid or ascending aorta) with the highest segmental mean of maximum (max) TBR at Baseline. The TBR of the qualifying segment was to be ≥ 1.6. If more than one artery qualified, the hottest (greatest mean of max TBR) artery was the qualifying artery. Baseline was defined as the value between Days -14 to -1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-treatment values.
次要结局
- Change From Baseline of the 'Most Diseased Segment (MSD)' Average Maximum TBR in the Qualifying Artery Following 12 Weeks of Treatment With GW856553 or Placebo in the Setting of Chronic Statin Therapy(Baseline (Days -14 to -1) and up to Week 12)
- Change From Baseline in Blood Concentration of High Sensitivity C-reactive Protein (Hs-CRP)(Baseline (Day 1) and Days 7, 14, 21, 28, 42, 56, 70, 84)
- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points(Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98)
- Mean Heart Rate at Indicated Time Points(Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98)
- Number of Participants With 12-lead Electrocardiogram (ECG) Findings(Days 1, 7, 14, 21, 28, 42, 56, 70, 84, 98)
- Number of Participants With Clinical Chemistry Abnormalities of PCI(Up to Follow-up (Day 98))
- Number of Participants With Hematology Abnormalities of PCI(Up to Follow-up (Day 98))
- Number of Participants With Urinalysis Dipstick Results(Day 1, 7, 14, 21, 28, 42, 56, 70, 84, 98)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Follow-up (Day 98))