A Multi-center, Open-label, Observational Study to Evaluate the Efficacy and Safety of Pitavastatin/Ezetimibe Tablets in Patients With Dyslipidemia Who Also Have Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Percentage change
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Pitavastatin/Ezetimibe tablets (a fixed-dose combination of Pitavastatin and Ezetimibe) in patients with dyslipidemia who also have metabolic syndrome in a real-world clinical setting.
As this is an observational study, participants will be treated according to the investigator's medical judgment and routine clinical practice. The study aims to observe the changes in low-density lipoprotein cholesterol (LDL-C) levels from baseline to 24 weeks and 48 weeks of treatment. Safety will also be assessed by monitoring any adverse events occurring during the 48-week observation period.
详细描述
This is a multi-center, open-label, prospective observational study designed to collect real-world evidence on the efficacy and safety of Pitavastatin/Ezetimibe tablets (2/10 mg and 4/10 mg). The study population consists of adult patients with dyslipidemia who satisfy the criteria for metabolic syndrome.
Key study procedures and objectives include:
Treatment: Participants who are prescribed Pitavastatin/Ezetimibe tablets as part of their routine care will be enrolled. No experimental intervention or forced treatment allocation will be performed.
Efficacy Evaluation: The primary endpoint is the percentage change in LDL-C levels from baseline (Visit 1) to 24 weeks (Visit 2). Secondary endpoints include changes in other lipid parameters (Total Cholesterol, Triglycerides, HDL-C, non-HDL-C, Apo B) and the percentage of patients reaching their target LDL-C levels at 24 and 48 weeks.
Safety Evaluation: All adverse events (AEs) and serious adverse events (SAEs) will be recorded and analyzed to assess the safety profile of the study drug in this specific patient population.
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
- •Age 19 years old at the time of written informed consent
- •Subjects diagnosed with dyslipidemia and metabolic syndrome
- •Subjects who had no treatment history with lipid regulators within 4 weeks prior to Visit1 or who had insufficient therapeutic effects from 8 weeks of treatment with lipid regulators using the same dosage and administration
- •Subjects who meet the following LDL-C levels according to the classification of cardiovascular disease risk groups* at Visit 1 or who are planned to be treated with Pitavastatin/Ezetimibe Tablets based on the judgment of the investigator
- •Subjects who voluntarily sign the informed consent form for study participation
排除标准
- •Individuals for whom Pitavastatin/Ezetimibe Tablets is contraindicated as specified in the label's Precautions for Use
- •Individuals who were treated with other investigational products (IP) or investigational devices within 4 weeks prior to participation in the present study or who are expected to have such treatment during the present study
- •Individuals who are considered to have difficulty participating in the study for other reasons based on the judgment of the investigator
研究组 & 干预措施
Pitavastatin/Ezetimibe Group
Patients with dyslipidemia and metabolic syndrome who are prescribed a fixed-dose combination of Pitavastatin and Ezetimibe
结局指标
主要结局
Percentage change
时间窗: 24 weeks
Percentage change in LDL-C levels from baseline
次要结局
未报告次要终点