An Observational Study to Evaluate the Safety and Effectiveness of Newvast Tab(Atorvastatin) in Korean Dyslipidemia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,716
- 试验地点
- 1
- 主要终点
- The incidence of myalgia
研究概览
简要总结
In this study, dyslipidemia patients visited the institutions during the study period and the effectiveness and safety of the treatment of Newvast® Tab(Atorvastatin) in real-practice.
During the routine medical visit, according to the investigator's judgment, with diagnosis that the Newvast® Tab(Atorvastatin) prescription is appropriate, regardless of medical history and concomitant-medication, and after deciding to start treatment, patients with Dyslipidemia who agreed to participate in the study were administered Newvast® Tab(Atorvastatin).
As this study is a non-interventional observational study, all subjects received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.
详细描述
This study is a multicenter, prospective, non-interventional, observational study of patients administering Atorvastatin(Newvast® Tab) to treat Dyslipidemia.
Data will be collected from patients receiving routine treatment at hospitals in South Korea. Each subject visits the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Atorvastatin(Newvast® Tab).
This study will approved by the institutions' IRBs and is in compliance with clinical research ethics regulations.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient was diagnosed with Dyslipidemia
- •Those who voluntarily consented in writing to this study
排除标准
- •(1) Patients for whom use of Newvast® Tab is prohibited
结局指标
主要结局
The incidence of myalgia
时间窗: 6 months
The incidence of myalgia associated with Newvast® Tab(Atorvastatin) treatment
次要结局
未报告次要终点