NCT00664742已完成4 期
The Effect Of Fluvastatin XL® Treatment On The Lipid Profile In Patients With Metabolic Syndrome
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
- Novartis
- 入组人数
- 614
- 试验地点
- 1
- 主要终点
- Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6
研究概览
简要总结
This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) 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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 3 criteria for metabolic syndrome National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III criteria)
- •Triglyceride (TG) < 400 mg/dl and Low Density Lipoprotein-Cholesterol (LDL-C) 100 mg/dl to 190 mg/dl
- •Written informed consent for participating in the study
排除标准
- •Severe renal disease or renal dysfunction
- •Chronic liver disease or liver function impairment
- •Inflammatory muscle dysfunction or findings of muscle problems
- •Severe cardiac failure
- •Other protocol defined inclusion exclusion criteria may apply
研究组 & 干预措施
Fluvastatin XL® Treatment
Experimental
80 mg once daily, at bedtime.
干预措施: Fluvastatin XL® (Drug)
结局指标
主要结局
Change in Total Cholesterol (TC), High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C) and Triglycerides (TG) Levels From Baseline to Week-6
时间窗: Baseline,6 weeks
Mean Absolute change in lipid profile parameters (TC, HDL-C, LDL-C and TG) calculated by the mean level for each parameter at week 6 minus the mean level at baseline.
次要结局
- Percentage of Participants Achieving Total Cholesterol (TC), Low Density Lipoprotein-Cholesterol (LDL-C), High Density Lipoprotein-Cholesterol (HDL-C) and Triglycerides (TG) Predefined Target Lipid Levels(Baseline, 6 weeks)
研究者
研究点 (1)
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