NCT04402112已完成不适用
Efficacy and Safety of Pitavastatin in a Real-wOrld Setting: Observational Study Evaluating saFety in Patient With Pitavastatin for Lipid Lowering Therapy in Korea
JW Pharmaceutical0 个研究点目标入组 28,343 人开始时间: 2012年4月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28,343
- 主要终点
- Number of participants with adverse events as assessed by CTCAE v4.0
研究概览
简要总结
The prospective, observational, non-comparative trial in South Korea was designed to evaluate the efficacy and safety of pitavastatin (Livalo) in clinical practice in 28,343 patients.
详细描述
This study was conducted in 893 facilities in Korea from 2 Apr 2012 to 1 Apr 2017. This study was designed to administer 1mg, 2mg, or 4mg pitavastatin to patients with hyperlipidemia at the age of 20 or older for at least 8 weeks.
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 in need of statin treatment who are taking or are planning to take Livalo tablets, or who are taking other statins or are planning to change to Livalo tablets.
排除标准
- •Patients with hypersensitivity to pitavastatin
- •Patients with active liver disease or untranslated transaminase levels Patients with a constant rise in
- •Patients with severe liver failure or biliary obstruction and patients with cholestasis
- •Patients who are receiving cyclosporine
- •Myopathy patients
- •Pregnant women or women of childbearing age and lactating women
- •Patients with genetic problems, such as galactose intolerance, Lapp lactose deficiency or glucose-galactose
- •Patients deemed inappropriate by the investigator
结局指标
主要结局
Number of participants with adverse events as assessed by CTCAE v4.0
时间窗: At 8 weeks after administration of pitavastatin
Incidence of musculoskeletal-related adverse events and rhabdomyolysis
次要结局
- Overall symptom satisfaction evaluation(At 8 weeks after administration of pitavastatin)
- Change in serum lipid profile before and after administration of pitavastatin(At screening and after 8 weeks)
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