A Multicenter, Single-arm, Prospective, Observational Study to Evaluate the Safety and Effectiveness of a Fixed-dose Combination Containing Valsartan and Rosuvastatin (Rovatitan® Tablet) in Patient With Hypertension and Hypercholesterolemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 主要终点
- The ratio of patients who reach the target LDLcholesterol
研究概览
简要总结
To evaluate the safety and effectiveness of a fixed-dose combination containing valsartan and rosuvastatin (Rovatitan® Tablet) in patient with hypertension and hypercholesterolemia
详细描述
- Effectiveness: the ratio of patients who reach target BP or LDL-cholesterol
- Safety: we will collect safety data
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
- •Patients who have hypertension and hyperlipidemia and older than 19 years
- •Patients who undertstand purpose and method of study, agree with study
排除标准
- •Patients who have been administered Rosuvastatin/Valsartan as a anti- hyperlipiddemic/anti-hypertensive drugs
- •Uncontrolled hypertension (SBP>=180mmHg or DBP>=110mmHg)
- •Patients who participated another clinical study or observational study 3 months ago.
研究组 & 干预措施
Treatment
Rovatitan 5/80mg (Rosuvastatin 5mg/Valsartan 80mg) Rovatitan 5/160mg (Rosuvastatin 5mg/Valsartan 160mg) Rovatitan 10/80mg (Rosuvastatin 10mg/Valsartan 80mg) Rovatitan 10/160mg (Rosuvastatin 10mg/Valsartan 160mg) Rovatitan 20/80mg (Rosuvastatin 20mg/Valsartan 80mg) Rovatitan 20/160mg (Rosuvastatin 20mg/Valsartan 160mg)
干预措施: Rosuvastatin/Valsartan (Drug)
结局指标
主要结局
The ratio of patients who reach the target LDLcholesterol
时间窗: 12weeks
target LDL refered to Hyperlipidemia pharmacotherapy
The ratio of patients who reach the target BP
时间窗: 12weeks
SBP/DBP\<140/90mmHg (\<60years), SBP/DBP\<150/90mmHg (\>=60years)
次要结局
- The ratio of patients who reach the target BP and LDL-c(12weeks)