NCT01439880已完成2 期
A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145 (Evolocumab)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 1,324
- 试验地点
- 188
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703)
排除标准
- •Experienced a treatment-related serious adverse event that led to investigational product (IP) discontinuation in the parent study
- •Have an unstable medical condition, in the judgment of the investigator
- •Known sensitivity to any of the products to be administered during dosing
- •Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.
Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.03, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.
次要结局
- Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52(Baseline of parent study and extension study weeks 24 and 52)
- Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52(Baseline of parent study and extension study weeks 24 and 52)
- Apolipoprotein B Level at Week 24 and Week 52(Baseline of parent study and extension study weeks 24 and 52)
- Total Cholesterol/HDL-C Ratio at Week 24 and Week 52(Baseline of parent study and extension study weeks 24 and 52)
- Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52(Baseline of parent study and extension study weeks 24 and 52)
研究者
研究点 (188)
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