NCT00644709已完成4 期
A Multicenter, Open-Label Extension Study Of High-Risk Hyperlipidemic Patients Treated With An Atorvastatin Starting Dose Adapted To Their Baseline LDL-C Level
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 196 人开始时间: 2003年9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
- 196
- 试验地点
- 1
- 主要终点
- Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL
研究概览
简要总结
A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of <115 mg/dL
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Completion of base study
- •Dyslipidemia and at high risk of CHD
排除标准
- •Impaired liver function
- •Gastrointestinal disease that could limit drug absorption
研究组 & 干预措施
Arm A
Experimental
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Achievement of low-density lipoprotein cholesterol (LDL-C) target of <115 mg/dL
时间窗: Week 52
次要结局
- Adverse events and laboratory test changes(Weeks 17, 34, and 52)
- Achievement of LDL-C target and total cholesterol target (<190 mg/dL) concomitantly(Week 52)
- LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and triglyceride levels(Baseline and Week 6 for base study; Baseline and Weeks 17, 34, and 52 for extension study)
- Percent change from baseline of base study in LDL-C, HDL-C, non-HDL-C (triglycerides of >200 mg/dL), total cholesterol, and triglycerides in patients who were statin-naive at baseline of base study(Baseline and Weeks 17, 34, and 52)
- Achievement of LDL-C target grouped according to whether patients had achieved target at the start of this extension study(Week 52)
- Achievement of LDL-C target by diabetic patients(Week 52)
- Achievement of LDL-C target(Weeks 17 and 34)
研究者
研究点 (1)
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