NCT00647543已完成4 期
A Multicenter, Eight-Week Treatment, Single-Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, And 40 Mg
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点目标入组 242 人开始时间: 2003年8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
- 242
- 试验地点
- 1
- 主要终点
- Percentage of patients who achieved low-density lipoprotein cholesterol (LDL-C) target
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol on patients from Thailand with high cholesterol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Dyslipidemic patients who were eligible for lipid lowering therapy
- •Willingness to follow study diet for 1 month prior to screening and for the duration of the study
排除标准
- •Use of other lipid lowering agents (6-week washout period)
- •Uncontrolled high blood pressure
- •Impaired liver function
研究组 & 干预措施
High Risk
Experimental
干预措施: Atorvastatin (Drug)
Low Risk
Experimental
干预措施: Atorvastatin (Drug)
Medium Risk
Experimental
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Percentage of patients who achieved low-density lipoprotein cholesterol (LDL-C) target
时间窗: Week 8
次要结局
- Change and percent change from baseline in high-density lipoprotein cholesterol (HDL-C)(Weeks 2, 4, and 8)
- Change and percent change from baseline in LDL/HDL ratio(Weeks 2, 4, and 8)
- Change and percent change from baseline in total cholesterol(Weeks 2, 4, and 8)
- Change and percent change from baseline in triglycerides(Weeks 2, 4, and 8)
- Adverse events and laboratory test changes(Weeks 2, 4, and 8)
- Percentage of patients who achieved LDL-C target(Weeks 2 and 4, and Week 8 with 1 step titration)
- Change and percent change from baseline in LDL-C(Weeks 2, 4, and 8)
研究者
研究点 (1)
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