NCT01879319已完成3 期
A Multicenter, 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 3.5 mL Personal Injector or a Prefilled Autoinjector/Pen.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 164
- 试验地点
- 28
- 主要终点
- Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8
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 a home-use setting using either an automated mini-doser (AMD) or autoinjector/pen (AI/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
结局指标
主要结局
Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8
时间窗: Weeks 4 and 8
Self-administration of evolocumab was assessed by a telephone interview at Weeks 4 and 8. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all. Results only include full administrations that occurred inside the prespecified visit window.
次要结局
- Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12(Baseline and Weeks 10 and 12)
研究者
研究点 (28)
Loading locations...
相似试验
已完成
3 期
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/PenPrimary HypercholesterolemiaMixed DyslipidemiaNCT01849497Amgen149
已完成
3 期
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3HyperlipidemiaNCT01984424Amgen511
已完成
3 期
An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney DiseaseAnemiaNCT00440557Johnson & Johnson Pharmaceutical Research & Development, L.L.C.375
已完成
不适用
Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)Myopic AstigmatismMyopiaNCT04283149Staar Surgical Company327
已完成
3 期
Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RAArthritis, RheumatoidNCT00418717Wyeth is now a wholly owned subsidiary of Pfizer42