NCT00644670已完成4 期
A Multicenter, Twelve-Week Treatment, Single-Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic High-Risk Patients Achieving LDL Cholesterol Targets 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 分布在 1 个国家目标入组 232 人开始时间: 2003年6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
- 232
- 试验地点
- 1
- 主要终点
- Percentage of subjects in entire group who achieved low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness of atorvastatin in lowering cholesterol and getting these high risk patients to their goals of LDL <115 mg/dl across starting doses of 10 mg, 20 mg, or 40 mg with one step titration.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dyslipidemia
- •At a high risk for coronary heart disease
排除标准
- •Use of higher than usual maintenance doses of statin drugs at screening
- •Uncontrolled diabetes or high blood pressure
- •Impaired liver function
研究组 & 干预措施
Previous Treatment with a Usual Maintenance Dose of a Statin
Experimental
干预措施: Atorvastatin (Drug)
Statin-Naive
Experimental
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Percentage of subjects in entire group who achieved low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL
时间窗: Week 12
次要结局
- Mean percent change from baseline in LDL-C, high-density lipoprotein cholesterol (HDL-C), non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, triglycerides, and apolipoprotein B for statin-naive patients(Weeks 6 and 12)
- Proportion of diabetic subjects in entire group who achieved LDL-C target(Week 12)
- Proportion of subjects across different LDL-C strata who achieved LDL-C target(Week 6)
- Proportion of subject on statin therapy at baseline who achieved LDL-C target and total cholesterol target (<190 mg/dL)(Week 12)
- Change from baseline in hemoglobin A1c levels(Week 12)
- Adverse events and laboratory test changes(Weeks 6 and 12)
- Proportion of subjects in entire group who achieved LDL-C target(Week 6)
研究者
研究点 (1)
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