NCT07489183已完成不适用
A Prospective, Open, Observational Study to Confirm the Lipid-lowering Effect, Changes in Glucose Metabolism, and Safety After 6 Months of Administration of Atostazet to Hypercholesterolemic Patients 65 Years of Age or Older
Dong Wha Pharmaceutical Co. Ltd.1 个研究点 分布在 1 个国家目标入组 641 人开始时间: 2021年8月23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
- 641
- 试验地点
- 1
- 主要终点
- Incidence of Adverse events
研究概览
简要总结
A prospective, open, observational study to confirm the lipid-lowering effect, changes in glucose metabolism, and safety after 6 months of administration of atostazet to hypercholesterolemic patients 65 years of age or older
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged ≥ 65 years
- •Primary Hypercholesterolemia
- •moderate risk or higher patient based on Korean Guidelines for the Management of Dyslipidemia (the 4th edition)
排除标准
- •Patients with a known hypersensitivity to any of the major or minor components of the study drug
- •Patients with active hepatic disease or unexplained persistently elevated serum aminotransferase levels
- •Patients with myopathies
- •Patients receiving glecaprevir and pibrentasvir
结局指标
主要结局
Incidence of Adverse events
时间窗: 24 weeks to the base
Incidence of Adverse events
次要结局
未报告次要终点
研究者
研究点 (1)
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