Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of EZETROL® in Usual Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,467
- 主要终点
- Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation
研究概览
简要总结
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of EZETROL® through collecting the safety information according to the Re-examination Regulation for New Drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants Who Receives EZETROL® In Usual Medical Practice
排除标准
- 未提供
结局指标
主要结局
Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation
时间窗: Up to 14 days after treatment discontinuation
Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment.
Mean Percent Change From Baseline to Treatment in Lipid Parameters
时间窗: Baseline to 4 weeks
The mean percent change from baseline to treatment in lipid parameters (total cholesterol \[TC\], low-density lipoprotein \[LDL\] cholesterol, high-density lipoprotein \[HDL\] cholesterol, triglycerides\[TG\]) in participants who received EZETROL over 4 weeks and then had available laboratory results in Lipid Parameters.
Overall Efficacy Evaluation of EZETROL®
时间窗: Baseline to 4 weeks
Participants who received EZETROL over 4 weeks and then have been evaluated for overall efficacy assessment by investigator showing to be improved, unchanged or worsened.
次要结局
未报告次要终点