A Multi-center, Randomized Study in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia to Assess Subjects' Ability to Administer a Full Dose of Evolocumab (AMG 145) in Home-use, Using Either a Prefilled Syringe or a Prefilled Autoinjector/Pen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 149
- 试验地点
- 27
- 主要终点
- Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4
研究概览
简要总结
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.
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
- •Fasting LDL-C at screening > 85 mg/dL
- •Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L)
排除标准
- •New York Heart Association (NYHA) III or IV heart failure
- •Uncontrolled cardiac arrhythmia
- •Uncontrolled hypertension
- •Type 1 diabetes or poorly controlled type 2 diabetes
- •Uncontrolled hypothyroidism or hyperthyroidism
研究组 & 干预措施
Evolocumab PFS
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4.
干预措施: Evolocumab Pre-filled Syringe (Biological)
Evolocumab AI/pen
Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4.
干预措施: Evolocumab AI/pen (Biological)
结局指标
主要结局
Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4
时间窗: Week 2 and Week 4
Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all.
次要结局
- Percent Change From Baseline in LDL-C at Week 6(Baseline and Week 6)