NCT04829149已完成不适用
A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea.
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 5,717 人开始时间: 2016年6月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,717
- 试验地点
- 1
- 主要终点
- Lipid profiles
研究概览
简要总结
A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea.
详细描述
The main objective of this study is to evaluate the effect of reducing LDL-C levels after 12 months of administration of Statin Monotherapy or Rosuzet Tab.(Rosuvastatin/Ezetimibe) in patients with dyslipidemia in Korea
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who is taking or is scheduled to take Statins therapy or Rosuzet Tab.
- •Not diagnosed with diabetes
- •Subject who can written informed consent voluntarily
- •Subject can continue to participate for 12 months on Study
排除标准
- •Patients for whom use of Rosuzet Tab. and Statin therapy is prohibited (e.g. patient who are hypersensitive to the main or compositional component of this drug, patient with active liver disease, patient with severe renal failure, patient using combinations with cyclosporin)
- •A pregnant or nursing woman
结局指标
主要结局
Lipid profiles
时间窗: 12 months
LDL-C percentage of change in Statin therapy group and Rosuzet group from baseline
次要结局
- Prescription rate(12 months)
- Medication compliance(12 months)
- Occurrence and aspect of new onset diabetes and adverse events(12 months)
- Reason for medication change(12 months)
- Lipid profiles(6, 12 months)
研究者
研究点 (1)
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