NCT00395486已完成4 期
A 6-week, Randomised, Open-label, Parallel Group, Multi-centre Study to Compare the Efficacy of Rosuvastatin 10mg With Atorvastatin 10mg in the Treatment of Metabolic Syndrome Subjects With Raised LDL-C
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6
研究概览
简要总结
The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg after 6 weeks of treatment in the ratio of ApoB/ApoA1 in subjects with metabolic syndrome.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of 3 or more of the following criteria;
- •Abdominal obesity (men >90cm women >80cm)
- •Triglycerides ≥ 150 mg/dL
- •HDL-C: men < 40 mg/dL, women < 50 mg/dL
- •BP ≥130/≥85 mmHg or anti-hypertensive treatment
- •Fasting blood glucose ≥100 mg dL or anti-diabetic treatment
- •Elevated LDL-C ;
- •≥130 mg/dL to < 220 mg/dL in lipid lowering agent naive subjects
- •≥100 mg/dL to < 200 mg/dL in subjects who have taken a lipid lowering drug(s) within 4 weeks of visit
- •Triglyceride < 500 mg/dL
排除标准
- 未提供
研究组 & 干预措施
Rosuvastatin
Experimental
干预措施: Rosuvastatin (Drug)
Atorvastatin
Active Comparator
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Percentage Change From Baseline in Ratio of Apolipoprotein (ApoB/ApoA1) at Week 6
时间窗: Baseline and 6 weeks
Samples for evaluation from all investigational sites will be delivered by courier to the central laboratory within 24 hours of blood being drawn. This outcome will be calculated by using the result of ApoB and ApoA1.
次要结局
- Percentage Change of Glucose Level(Baseline and 6 weeks)
- Percentage of Subjects Reaching Their LDL-C Target Goal(Baseline and 6 weeks)
- Percentage of Subjects Reaching Their Low-Density Lipoprotein-C (LDL-C) and Non High-Density Lipoprotein-C (HDL-C) Target Goal(Baseline and 6 weeks)
- Percentage Change of Insulin Resistance Using HOMA-R(Baseline and 6 weeks)
- Percentage Change of Insulin Resistance Using QUICKI(Baseline and 6 weeks)
- Percentage Change of Total Cholesterol (TC)(Baseline and 6 weeks)
- Percentage Reduction of Low-Density Lipoprotein-C (LDL-C)(Baseline and 6 weeks)
- Percentage Change of Triglycerides (TG)(Baseline and 6 weeks)
- Percentage Change of Apolipoprotein A1 (ApoA1)(Baseline and 6 weeks)
- Percentage Change of High-Density Lipoprotein-C (HDL-C)(Baseline and 6 weeks)
- Percentage Change of Apolipoprotein B (ApoB)(Baseline and 6 weeks)
研究者
研究点 (1)
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