A Multicenter, Prospective, Non-interventional Observational Study to Investigate the Change in Blood Cholesterol With Mevalotin® Tablet Administration in Korean Menopausal Women Aged 50 Years or More Who Require Treatment of Dyslipidemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,060
- 试验地点
- 58
- 主要终点
- Change from baseline in low-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration
研究概览
简要总结
This study will investigate the efficacy and safety based on the observation of the blood cholesterol change with Mevalotin® Tablet administration in Korean menopausal women aged 50 years or more who require treatment of dyslipidemia.
详细描述
In this prospective, observational study, patient data (eg, clinical outcomes in actual clinical settings, demographic information, medical treatment-related information, Mevalotin® Tablet administration start date [Index date], and the lipid profile results at Week 24 after Mevalotin® Tablet administration start date) will be collected from medical records. No study drug will be administered in this study.
Patient data will be used to determine the change in blood cholesterol with Mevalotin® Tablet administration (5 mg, 10 mg, 20 mg, 40 mg as determined by Investigator in clinical practice) in Korean menopausal women aged 50 years or more who require treatment of dyslipidemia.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Menopausal women aged 50 years or more diagnosed with dyslipidemia
- •Menopause was defined as the condition of not having menstruation for 1 year with no specific cause or being diagnosed with menopause at the discretion of an investigator (except for the case of being diagnosed with menopause for a surgical reason within 5 years), and the menopausal status is confirmed as of the Mevalotin® Tablet administration start date (Index date).
- •Patients who are determined to be prescribed with Mevalotin® Tablet at the discretion of an investigator or patients who started Mevalotin® Tablet administration within 6 weeks prior to enrollment in this observational study (however, in case of patients switching from statins to Mevalotin® Tablet, only those who receive from low/intermediate intensity statins treatment to low/intermediate intensity statins treatment can be enrolled in this study)
- •Patients who provided voluntary written consent to take part in this observational study
排除标准
- •Patients with a history of cancer within 5 years (however, patients with a history of brain tumor, breast cancer, uterine cancer, ovarian cancer, or endometrial cancer are excluded from enrollment regardless of duration.)
- •Patients who received hormone replacement therapy within 1 year of enrollment
- •Patients who are determined to be ineligible for participation in this observational study
研究组 & 干预措施
Mevalotin
Korean menopausal women aged 50 years or more who required treatment of dyslipidemia and received Mevalotin® tablets.
干预措施: Mevalotin (Drug)
结局指标
主要结局
Change from baseline in low-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration
时间窗: Week 24 post-dose
The change from baseline (mg/dL) in low-density lipoprotein cholesterol (LDL-C) will be assessed at Week 24 from blood plasma samples.
次要结局
- Percent change from baseline in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration(Week 24 post-dose)
- Change from baseline in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 48 after Mevalotin® Tablet administration(Week 48 post-dose)
- Change from baseline in total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration(Week 24 post-dose)
- Number of participants with treatment-emergent adverse events after Mevalotin® Tablet administration(Week 48 post-dose)
- Percent change from baseline in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 48 after Mevalotin® Tablet administration(Week 48 post-dose)