A Multicenter, Randomized, Factorial, Double-blinded, Double-dummy Phase Ⅲ Trial to Evaluate the Efficacy and Safety of the Coadministration of Valsartan 160mg and Rosuvastatin 20mg in Comparison to Each Component Administered Alone in Patients With Hypertension and Hyperlipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- sitDBP Changes at Week 8 From Baseline
研究概览
简要总结
This study aims to evaluate the efficacy and safety of the coadministration of valsartan (Diovan®) 160mg and rosuvastatin (Crestor®) 20mg in comparison to each component administered alone in patients with hypertension and hyperlipidemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 20-80 years who has hypertension and hyperlipidemia
- •Patient who has a Hypertension
- •Patient who has a Hyperlipidemia according to NCEP-ATP III guideline(2004)
- •Patient who signed the Informed Consent Form after receiving an explanation on the purpose, methods, and effect of the study
排除标准
- •If blood pressure and fasting serum lipid level measured at screening and Visit 2 (0 week) satisfy the following criteria 1) sitSBP≥180mmHg or sitDBP≥110mmHg (For high risk group, sitSBP≥ 160mmHg or sitDBP ≥100mmHg ) 2) LDL-C>250mg/dL , or TG≥ 400mg/dL
- •If sitSBP difference between the right and left arms >20mmHg or sitDBP difference between the right and left arms > 10mmHg at screening
- •When blood pressure is repeatedly measured from the selected arm at screening, if sitSBP difference ≥ 20mmHg or sitDBP difference ≥10mmHg
- •Patient with orthostatic hypotension accompanying symptoms at screening (decrease in sitDBP ≥10mmHg or decrease in sitSBP ≥ 20mmHg )
研究组 & 干预措施
Valsartan 160mg, Rosuvastatin 20mg
Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
干预措施: Valsartan 160mg (Drug)
Valsartan 160mg, Rosuvastatin 20mg
Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.
干预措施: Rosuvastatin 20mg (Drug)
Valsartan 160mg, Rosuvastatin 20mg placebo
Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
干预措施: Valsartan 160mg (Drug)
Valsartan 160mg, Rosuvastatin 20mg placebo
Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
干预措施: Rosuvastatin 20mg placebo (Drug)
Valsartan 160mg placebo, Rosuvastatin 20mg
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.
干预措施: Rosuvastatin 20mg (Drug)
Valsartan 160mg placebo, Rosuvastatin 20mg
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.
干预措施: Valsartan 160mg placebo (Drug)
Placebo
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
干预措施: Valsartan 160mg placebo (Drug)
Placebo
Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
干预措施: Rosuvastatin 20mg placebo (Drug)
结局指标
主要结局
sitDBP Changes at Week 8 From Baseline
时间窗: 8 weeks
sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline
LDL-C Percentage Changes at Week 8 From Baseline
时间窗: 8 weeks
LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline
次要结局
未报告次要终点