A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients- A Multicenter, Randomized, Double-blind, Placebo-controlled Study of SB-480848 to Evaluate the Efficacy and Safety -
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity
研究概览
简要总结
The primary objective of this study is to examine the effects of SB-480848 on plasma lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a 4-week treatment with SB-480848.
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
- 20 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
SB480848 160mg Group
SB480848 160mg/day
干预措施: SB480848 160mg EC Tablet (Drug)
SB480848 80mg Group
SB480848 80mg/day
干预措施: SB480848 80mg EC Tablet (Drug)
Placebo Group
Matched Placebo
干预措施: SB480848 Placebo Tablet (Drug)
SB480848 40mg Group
SB480848 40mg/day
干预措施: SB480848 40mg EC Tablet (Drug)
结局指标
主要结局
Change From Baseline to Week 4 in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity
时间窗: Baseline (Week 0, Visit 2) and Week 4
Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 4) assessment value minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The natural logarithm (log) was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken the change from Baseline on that log original value, calculated as log (post-Baseline value \[week 4\]) minus log (Baseline value).
次要结局
- Percent Inhibition of Lp-PLA2 Activity in Plasma Over Time(Baseline (Week 0, Visit 2) up to Follow-up (up to Week 7))
- Change From Baseline in Lp-PLA2 Activity at Week 1, 2 and Follow-up(Baseline (Week 0, Visit 2), Week 1, Week 2 and Follow-up ( Week 7))
