Open-labelled, Single Arm, Phase IV Clinical Study to Evaluate the Impact of Rosuvastatin on Lipid Levels in Patients With Metabolic Syndrome (EFFORT)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
研究概览
简要总结
The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •metabolic syndrome (according to National Cholesterol Education Program (NCEP) Adenosine triphosphate (ATP) Ill criteria)
- •LDL-Cholesterol > 130mg/dl
- •HDL-Cholesterol < 40mg/dl in males and <50mg/dl in females
- •Triglycerides < 400 mg/dl
排除标准
- •With a concomitant coronary disease
- •Currently under statin therapy or previously treated with statins within the last 6 months
研究组 & 干预措施
Rosuvastatin
medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.
干预措施: rosuvastatin (Drug)
结局指标
主要结局
LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
时间窗: 3 months (from enrollment to last visit)
LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal Total Cholesterol Level
时间窗: Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Baseline
Total Cholesterol Level After 3 Months of Rosuvastatin Treatment
时间窗: 3 months (from enrollment to last visit)
Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal HDL-cholesterol Level
时间窗: Baseline
HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment
时间窗: 3 months (from enrollment to last visit)
HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Basal LDL-cholesterol Level
时间窗: Baseline
LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Basal Triglyceride Level
时间窗: Baseline
Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)
Triglyceride Level After 3 Months of Rosuvastatin Treatment
时间窗: 3 months (from enrollment to last visit)
Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)
Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment
时间窗: 3 months (from enrollment to last visit)
Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: \<100 mg/dL; HDL-cholesterol: For males \>40 mg/dL, for females \>50 mg/dL; non-HDL-cholesterol: \<130 mg/dL
Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment
时间窗: 3 months (from enrollment to last visit)
Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment
Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment
时间窗: 3 months (from enrollment to last visit)
Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment
次要结局
- Basal Interleukin 6 (IL-6) Level(Baseline)
- Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment(3 months (from enrollment to last visit))
- Basal Interleukin 8 (IL-8) Level(Baseline)
- Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment(3 months (from enrollment to last visit))
- Basal Interleukin 1 (IL-1) Level(Baseline)
- Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment(3 months (from enrollment to last visit))
- Basal Interleukin 10 (IL-10) Level(Baseline)
- Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment(3 months (from enrollment to last visit))
- Basal Tumor Necrosis Factor (TNF) Level(Baseline)
- Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment(3 months (from enrollment to last visit))
- Basal High Sensitivity C-reactive Protein (Hs-CRP) Level(Baseline)
- High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment(3 months (from enrollment to last visit))
- Basal LDL-3 Level(Baseline)
- LDL-3 Level After 3 Months of Rosuvastatin Treatment(3 months (from enrollment to last visit))
- Basal LDL-4 Level(Baseline)
- LDL-4 Level After 3 Months of Rosuvastatin Treatment(3 months (from enrollment to last visit))
- Basal LDL-5 Level(Baseline)
- LDL-5 Level After 3 Months of Rosuvastatin Treatment(3 months (from enrollment to last visit))
- Basal LDL-6 Level(Baseline)
- LDL-6 Level After 3 Months of Rosuvastatin Treatment(3 months (from enrollment to last visit))
- Basal LDL-7 Level(Baseline)
- LDL-7 Level After 3 Months of Rosuvastatin Treatment(3 months (from enrollment to last visit))
- Basal Large HDL Subfraction Level(Baseline)
- Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment(3 months (from enrollment to last visit))
- Basal Intermediate HDL Subfraction Level(Baseline)
- Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment(3 months (from enrollment to last visit))
- Basal Small HDL Subfraction Level(Baseline)
- Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment(3 months (from enrollment to last visit))
- Number of Patients With Adverse Events(3 months (from enrollment to last visit))