Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab (AMG 145) in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Laboratory values for HDL-C
研究概览
简要总结
The purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in Japan.
详细描述
The objectives of study are to 1) determine the incidence of adverse events and adverse drug reactions among patients receiving evolocumab for up to 2 years, and 2) identify and describe patient characteristics (e.g. demographics, medical history) associated with the safety and effectiveness of evolocumab therapy for the patients with Familial Hypercholesterolemia (Heterozygous or Homozygous) and Hypercholesterolemia in Japan
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients for whom evolocumab is prescribed at participating medical institutions in accordance with the approved Japan prescribing information (i.e., those with Familial Hypercholesterolemia (Heterozygous or Homozygous and Hypercholesterolemia who have high risk factors for cardiovascular event and do not respond sufficiently to HMGCoA reductase inhibitor (statin) for hypercholesterolemia).
排除标准
- •No exclusion criteria are applied.
结局指标
主要结局
Laboratory values for HDL-C
时间窗: 2 years
Incidence of adverse events and adverse drug reactions
时间窗: 2 years
The incidence of adverse events and drug reactions will be described using the same units (events per 1000 person-years). Adverse events (including seriousness and causal relations to drug or device), inclusive of reaction at local injection sites, and other safety information (e.g. overdose, lack of effectiveness, pregnancy and lactation with or without adverse event) will be described.
Laboratory values for LDL-C
时间窗: 2 years
Laboratory values for total cholesterol
时间窗: 2 years
Laboratory values for triglycerides
时间窗: 2 years
Laboratory values for lipoprotein(a)
时间窗: 2 years
This will be measured if feasible.
Laboratory values for Apolipoprotein (Apo) A1
时间窗: 2 years
This will be measured if feasible.
Laboratory values for Apolipoprotein (Apo) Apo B
时间窗: 2 years
This will be measured if feasible.
Laboratory values for Apolipoprotein (Apo) Apo E
时间窗: 2 years
This will be measured if feasible.
次要结局
未报告次要终点