NCT06293261已完成不适用
Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia
Yuhan Corporation39 个研究点 分布在 1 个国家目标入组 5,047 人开始时间: 2020年6月27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
- 5,047
- 试验地点
- 39
- 主要终点
- Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)
研究概览
简要总结
This study is to confirm the long-term efficacy and safety of Rosuampin Tab. in patients with hypertension and hypercholesterolemia
详细描述
All treatments, such as drug administration and clinical laboratory tests performed after Rosuampine administration, are performed according to the investigator's medical judgment, and information to be confirmed in this observational study is collected for up to 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Aged ≥ 19 years
- •Patients with hypertension and hypercholesterolemia who are receiving Rosuampin medication or need Rosuampin medication according to the medical judgment of the investigator
- •Written informed consent
排除标准
- •Patients with hypersensitivity to components of this drug or other dihydropyridine drugs
- •A woman who is pregnant or likely to be pregnant, a woman of childbearing age who does not use appropriate contraception and a nursing woman
- •a patient with severe liver failure
- •Patients with active liver disease who include continuous serum transaminase elevation of unknown cause or serum transaminase elevation over three times the upper limit of normal
- •a patient with severe aortic valvular stenosis
- •a myopathy patient
- •a cyclosporine co-administered patient
- •a patient with severe renal failure (CLcr, creatinine clearance <30 mL/min)
研究组 & 干预措施
Rosuampin 5/5mg (Rosuvastatin 5mg + Amlodipine 5mg)
干预措施: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg (Drug)
Rosuampin 10/5mg (Rosuvastatin 10mg + Amlodipine 5mg)
干预措施: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg (Drug)
Rosuampin 20/5mg (Rosuvastatin 20mg + Amlodipine 5mg)
干预措施: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg (Drug)
Rosuampin 10/10mg (Rosuvastatin
干预措施: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg (Drug)
结局指标
主要结局
Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)
时间窗: Baseline, 12 Months
次要结局
- Change from baseline to 6/12 months in SBP and DBP(Baseline, 6, 12 Months)
- Percent change from baseline to 6/12 months in Lipid Profile (TC, LDL-C, TG, HDL-C)(Baseline, 6, 12 Months)
- Change from baseline to 6/12 months in hs-CRP(Baseline, 6, 12 Months)
- Change from baseline to 6/12 months in Diabetes indicator (Fasting Blood Glucose)(Baseline, 6, 12 Months)
- Change from baseline to 6/12 months in Diabetes indicator ( HbA1c)(Baseline, 6, 12 Months)
研究者
研究点 (39)
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