NCT05889143进行中（未招募）不适用
A Prospective, Non-Intervention, Multi-Center Observational Study to Evaluate the Efficacy and Safety of CREZET Tablet in Patients With Dyslipidemia
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 15,000 人开始时间: 2023年5月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- The Rate of change in LDL-C
研究概览
简要总结
This observation study is to evaluate blood lipid-lowering effects and liver/renal safety, changes in HbA1c and FPG in patients with dyslipidemia who administered CREZET tablets for 24 weeks.
详细描述
A subject who is diagnosed with dyslipidemia and scheduled to administer CREZET tablets, will be enrolled in this study based on the doctor's medical decision.
The CREZET Tablet will be administered for 24 weeks, and the data including demographic information, body measurement, vital signs and etc will be collected during the study period.
The data collection point is as follows.
- Visit 1 (baseline, day 0)
- Visit 2 (at 12 weeks)
- Visit 3 (at 24 weeks)
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •an adult male and female over 19 years of age
- •A patient with dyslipidemia who is scheduled to administer Crezet tablets according to the medical judgment of the investigator based on permission
- •A person who voluntarily participates in the observational study and agrees in writing to comply with the subject's precautions during the study period after hearing and understanding the detailed explanation of the characteristics of the observational study and the drug to be studied
排除标准
- •A person who is prohibited from administering according to the permission of the Crezet definition
- •Patients who overreact to the principal or component of the Crezet definition
- •Patients with active liver disease or patients with persistent high symptoms of serum aminotransferase levels
- •a patient with a muscle disease
- •a patient administered in combination with a cyclosporine-med
- •Patients with severe renal failure (Creatinine Clearance (CLcr) < 30 mL/min)
- •Women and lactating women who may be pregnant or pregnant
- •Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •A person who has a history of taking Crezet tablets within three months of the date of registration
- •A person who is deemed inappropriate to participate in this observational study based on the judgment of investigator.
研究组 & 干预措施
Mucotra® SR Tab
干预措施: Ezetimibe/Rosuvastatin (Drug)
结局指标
主要结局
The Rate of change in LDL-C
时间窗: 24 weeks
The Rate of change in LDL-C at 24 weeks from baseline
次要结局
- The chanage in lipid variable(24 weeks)
- The change in AST(24 weeks)
- The change in FPG(24 weeks)
- The change in HbA1c(24 weeks)
- The Rate of change in LDL-C(12 weeks)
- Percentage of subjects who reached LDL-C target(24 weeks)
- The change in ALT(24 weeks)
研究者
研究点 (1)
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