NCT06866509已完成不适用
A Prospective, Multicenter, Non-Interventional Observational Study to Investigate Changes in Blood Lipid Levels and Safety Following Administration of Litorvazet® Tablets in Patients With Dyslipidemia
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2022年2月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Change in LDL-C Levels Compared to Baseline
研究概览
简要总结
This study aims to investigate the lipid-lowering effects and safety of administering Litorvazet tablets (ezetimibe/atorvastatin) over a 24-week period in patients with dyslipidemia scheduled to receive Litorvazet tablets in a real-world clinical setting.
详细描述
In a real-world clinical setting, Litorvazet® tablets will be administered to patients based on the investigator's medical judgment in accordance with the approved prescribing information (indications, dosage, and administration, precautions for use, etc.).
Participants for data collection in this study will be patients diagnosed with dyslipidemia as determined by the judgment of their attending physician.
All treatments, including drug administration and clinical laboratory tests conducted after the administration of Litorvazet® tablets, will be carried out based solely on the investigator's (attending physician's) medical judgment and will not be influenced by the patient's participation in the study. Information relevant to this observational study will be collected for up to 24 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Male and female adults aged 19 years or older at the time of the screening visit.
- •Patients with dyslipidemia who are scheduled to receive Litorvazet® tablets based on the investigator's (treating physician's) medical judgment and in accordance with the approved indications.
- •Individuals who have voluntarily provided written consent to participate in this study.
排除标准
- •Individuals who meet any contraindications for Litorvazet® tablets as specified in the product labeling:
- •Those with hypersensitivity to any components of this medication.
- •Patients with active liver disease or those with persistently elevated serum transaminase levels of unknown cause.
- •Patients with muscle disorders.
- •Pregnant women, women who may be pregnant, or breastfeeding mothers.
- •Women of childbearing potential who are not using appropriate contraceptive methods.
- •Patients receiving glecaprevir and pibrentasvir.
- •Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •Individuals with a history of receiving Litorvazett® tablets prior to participating in this study.
- •Individuals deemed unsuitable for participation in this observational study by the investigator (treating physician) for reasons beyond those listed above.
研究组 & 干预措施
Patients With Dyslipidemia
Patients With Dyslipidemia
干预措施: Litorvazet Tablet 10/10mg (Drug)
Patients With Dyslipidemia
Patients With Dyslipidemia
干预措施: Litorvazet Tablet10/20mg (Drug)
Patients With Dyslipidemia
Patients With Dyslipidemia
干预措施: Litorvazet Tablet 10/40mg (Drug)
结局指标
主要结局
Change in LDL-C Levels Compared to Baseline
时间窗: at Week 24
Change in LDL-C Levels at Week 24 Compared to Baseline
次要结局
- Changes in LDL-C levels compared to baseline [excluding primary endpoints].(at Week 24)
- Changes in Non-HDL-C levels compared to baseline(at Week 24)
- Percentage changes (%) in Non-HDL-C levels compared to baseline(at Week 24)
- Percentage changes (%) in LDL-C levels compared to baseline [excluding primary endpoints].(at Week 24)
- Percentage changes (%) in HDL-C levels compared to baseline(at Week 24)
- Changes in HDL-C levels compared to baseline(at Week 24)
- Changes in TG levels compared to baseline(at Week 24)
- Percentage changes (%) in TG levels compared to baseline(at Week 24)
- Percentage changes (%) in TC levels compared to baseline(at Week 24)
- Changes in diastolic blood pressure compared to baseline(at Week 24)
- Percentage changes (%) in systolic blood pressure compared to baseline(at Week 24)
- Changes in TC levels compared to baseline(at Week 24)
- Changes in ALT levels compared to baseline(at Week 24)
- Changes in AST levels compared to baseline(at Week 24)
- Percentage changes (%) in ALT levels compared to baseline(at Week 24)
- Percentage changes (%) in AST levels compared to baseline(at Week 24)
- Changes in systolic blood pressure compared to baseline(at Week 24)
- Percentage changes (%) in diastolic blood pressure compared to baseline(at Week 24)
- Changes in HbA1c levels compared to baseline(at Week 24)
- Percentage changes (%) in HbA1c levels compared to baseline(at Week 24)
- Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels(at Week 24)
- Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels(at Week 24)
- Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels(at Week 24)
- Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels(at Week 24)
- Changes in LDL-C levels in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment(at Week 24)
- Goal attainment rates in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment(at Week 24)
- Goal maintenance rates in patients who achieved their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment(at Week 24)
- Changes in LDL-C levels in patients who did not achieve their therapeutic targets based on baseline risk levels, categorized by the previously administered dyslipidemia treatment(at Week 24)
研究者
研究点 (1)
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