Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of VYTORIN in Usual Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,089
- 主要终点
- Mean Percent Change From Baseline to Treatment in Lipid Parameters
研究概览
简要总结
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting the safety and efficacy 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 Vytorin In Usual Medical Practice Within Local Label For The First Time
排除标准
- 未提供
结局指标
主要结局
Mean Percent Change From Baseline to Treatment in Lipid Parameters
时间窗: Baseline and up to 5 years
The mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides\[TG\]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years.
Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation
时间窗: Up to 14 days after the treatment discontinuation
Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.
次要结局
未报告次要终点