NCT07083206招募中不适用
A Multi-center, Prospective, Non-intervention, Observational Study to Evaluate the Effectiveness and Safety of Switching to Pevarozet Tablet in Patients With Hypercholesterolemia Previously Treated With Atorvastatin or Rosuvastatin Monotherapy
Ahn-Gook Pharmaceuticals Co.,Ltd1 个研究点 分布在 1 个国家目标入组 4,500 人开始时间: 2025年7月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,500
- 试验地点
- 1
- 主要终点
- Rate of reaching the target LDL-C level
研究概览
简要总结
The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.
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
- •Adults aged 19 years or older
- •Patients diagnosed with hypercholesterolemia who have been stably treated with atorvastatin or rosuvastatin monotherapy for at least 3 months, and for whom switching to fixed-dose combination pitavastatin/ezetimibe has been clinically decided
- •Patients with available clinical laboratory test results related to efficacy and safety (TC, TG, HDL-C, LDL-C, AST, ALT, Cr/eGFR) within 12 months prior to switching to fixed-dose combination pitavastatin/ezetimibe (no changes in statin regimen or dosage during that period)
- •Individuals (or their legally authorized representatives) who voluntarily provide written informed consent to participate in the study
排除标准
- •Known hypersensitivity or history of hypersensitivity to any component of the investigational product
- •Patients with active liver disease or persistent, unexplained elevations of aminotransferase levels
- •Patients with severe hepatic impairment, biliary obstruction, or cholestasis
- •Patients currently receiving cyclosporine treatment
- •Patients diagnosed with myopathy
- •Pregnant or breastfeeding women, or women who may be pregnant
- •Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •Any patient who, in the opinion of the investigator, is deemed unsuitable for study participation
结局指标
主要结局
Rate of reaching the target LDL-C level
时间窗: 12 months after administration
次要结局
未报告次要终点
研究者
研究点 (1)
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