NCT07445542已完成不适用
A Multi-center, Open-label, Observational Study to Evaluate the Efficacy and Safety of Pitavastatin/Ezetimibe After Switching From Statin Monotherapy to Pitavastatin/Ezetimibe in Patients With Hypercholesterolemia
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 6,927 人开始时间: 2021年12月18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
- 6,927
- 试验地点
- 1
- 主要终点
- LDL-C level
研究概览
简要总结
A Multi-center, Open-label, Observational Study to evaluate the Efficacy and Safety of Pitavastatin/Ezetimibe after switching from Statin Monotherapy to Pitavastatin/Ezetimibe in patients with Hypercholesterolemia
详细描述
A Multi-center, Open-label, Observational Study
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 (≥19 years) with hypercholesterolemia.
- •On a stable dose of statin monotherapy for at least 8 weeks.
- •Scheduled to switch to Pitavastatin/Ezetimibe per investigator's decision.
- •Provided voluntary written informed consent.
排除标准
- •Use of other lipid-lowering therapies within 4 weeks before screening.
- •History of clinically significant laboratory abnormalities within 1 year.
- •Participation in other clinical trials within 4 weeks.
- •Contraindications to Pitavastatin/Ezetimibe
研究组 & 干预措施
switching to a fixed-dose combination of pitavastatin and ezetimibe
Patients with hypercholesterolemia who have been treated with a stable dose of statin monotherapy for at least 8 weeks and are switching to Pitavastatin/Ezetimibe
结局指标
主要结局
LDL-C level
时间窗: From enrollment to the end of treatment at 24 weeks
Percent change from baseline in LDL-C level at Week 24
次要结局
未报告次要终点
研究者
研究点 (1)
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