NCT03217409已完成4 期
A Multicenter Clinical Trial to Compare the Efficacy and Safety Between Rosuvastatin/Ezetimibe Combination and Monotherapy of Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia
Yuhan Corporation4 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2017年8月10日最近更新:
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
- 入组人数
- 85
- 试验地点
- 4
- 主要终点
- Low density lipoprotein cholesterol (LDL-C) (%)
研究概览
简要总结
A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with Diabetes Mellitus and Hypercholesterolemia.
详细描述
This trial is conducted to compare the efficacy and safety between Rosuvastatin/Ezetimibe combination and Rosuvastatin monotherapy in patients with Diabetes Mellitus and Hypercholesterolemia for 8 weeks.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥ 19 or ≤ 75 years of age
- •Subjects undergoing treatment for type 2 diabetes
- •Subjects undergoing treatment of statin for hypercholesterolemia
- •Fasting LDL-C ≤ 250mg/dL at the screening visit
- •Fasting LDL-C ≥70mg/dL or ≤ 160mg/dL at the randomization visit
- •Fasting TG<500mg/dL
排除标准
- •Subjects with hypersensitivity reaction to Statin and Ezetimibe
- •Subjects with severe kidney disease
- •Subjects with HIV positive result at the screening
- •Pregnant or breast-feeding subjects
- •Subjects with taking any medication affecting level of LDL (Fenofibrate, Omega 3 fatty aicd etc.)
- •Insulin-treated Subjects
- •Other exclusions applied
研究组 & 干预措施
Rosuvastatin+Ezetimibe
Experimental
Rosuvastatin 5mg+Ezetimibe 10mg Rosuvamibe ® Tablet, 1T, Once a day/8week
干预措施: Rosuvastatin+Ezetimibe (Drug)
Rosuvastatin
Active Comparator
Rosuvastatin 5mg Monorova ® Tablet, 1T, Once a day/8week
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Low density lipoprotein cholesterol (LDL-C) (%)
时间窗: baseline, Week 8
The rate of change(%) of LDL-C at Week 8 compared to the baseline
次要结局
- Low density lipoprotein cholesterol (LDL-C) (100mg/dL)(baseline, Week 8)
- Thiobarbituric acid reactive substances(TBARs)(baseline, Week 8)
- HbA1C, Glycated albumin, Homeostasis model assessment Insulin resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß) resistance(HOMA-IR), Homeostasis model assessment ß cell(HOMA-ß)(baseline, Week 8)
- LDL-C, Non HDL-C, HDL-C, Triglyceride(TG), Total cholesterol(TC), Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C) Apolipoprotein A1, Apolipoprotein B, Lipid ratios (LDL-C/HDL-C, TC/HDL-C, Non- HDL-C/HDL-C)(baseline, Week 8)
- Fibroblast Growth Factor 21(baseline, Week 8)
研究者
研究点 (4)
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