NCT02940366Unknown4 期
the Long-term Effects of High-doSe pitavaStatin on Diabetogenicity in Comparison With Atorvastatin in Patients With Metabolic Syndrome (LESS-DM) Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Absolute change in HbA1c level
研究概览
简要总结
This purpose of this study is to evaluate effect of high-dose Pitavastatin on glucose control in patients 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as metabolic syndrome according to National cholesterol Education Program criteria
- •Patients with hypercholesterolemia who required to start statin therapy
排除标准
- •overt diabetes
- •acute coronary syndrome within 2 months
- •acute cerebrovascular event within 2 months
- •recent treatment of statin within 1month
- •recent diagnosed neoplasm
- •recent diagnosed liver disease
- •chronic kidney disease
- •patients with myopathy
- •pregnant women, nursing mothers, women with possibility of pregnant
- •patients being adminstered cyclosporine
- •patients with genetic disease such as galactose intolerance, lactose intolerance, glucose-galactose malabsorption
- •patients with treatment cyclosporin
研究组 & 干预措施
Pitavastatin 4 mg orally daily
Experimental
干预措施: Pitavastatin 4 mg orally daily (Drug)
Atorvastatin 20 mg orally daily
Placebo Comparator
干预措施: Atorvastatin 20 mg orally daily (Drug)
结局指标
主要结局
Absolute change in HbA1c level
时间窗: baselina and after 24months treatment
次要结局
未报告次要终点
研究者
Hyung-Kwan Kim
Director, Division of Cardiology, Clinical Professor
Seoul National University Hospital
研究点 (1)
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