NCT00645424已完成4 期
A Randomized, 12-Week, Open Labeled Study To Evaluate The Efficacy And Safety Of Once Daily Atorvastatin In Diabetes Mellitus Type 2 With Hyperlipidemia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2003年12月最近更新:
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
- 155
- 试验地点
- 1
- 主要终点
- Percentage change in LDL-C levels from baseline to Week 12
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of atorvastatin for the treatment of Taiwanese patients with diabetes and high cholesterol.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Taiwanese outpatients with type 2 diabetes mellitus and high cholesterol
- •Hemoglobin A1c levels of ≤10%, LDL-C levels of ≥130 mg/dL, and serum triglyceride levels of <400 mg/dL
排除标准
- •Type I diabetes mellitus
- •Secondary causes of high cholesterol
- •Elevated liver enzymes
研究组 & 干预措施
Arm A
Experimental
干预措施: atorvastatin (Drug)
Arm B
Experimental
干预措施: atorvastatin (Drug)
Arm C
Experimental
干预措施: atorvastatin (Drug)
结局指标
主要结局
Percentage change in LDL-C levels from baseline to Week 12
时间窗: Week 12
Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12
时间窗: Week 12
次要结局
- Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12(Weeks 4, 8, and 12)
- Vital signs at Weeks 4, 8, and 12(Screening and at Weeks 4, 8, and 12)
- Percentage change in LDL-C levels from baseline at Weeks 4 and 8(Weeks 4 and 8)
- Percentage of LDL-C responders at Weeks 4 and 8(Weeks 4 and 8)
- Clinical laboratory changes at Weeks 4, 8, and 12(Screening and at Weeks 4, 8, and 12)
- Adverse events at Weeks 4, 8, and 12(Baseline and at Weeks 4, 8, and 12)
- Percentage of subjects with total cholesterol (TC) levels of <160 mg/dL (TC responders) at Weeks 4, 8, and 12(Weeks 4, 8, and 12)
研究者
研究点 (1)
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