Evaluation of Antihypertensive Activity of Valsartan and Amlodipine Compared to Losartan and Amlodipine Through Ambulatory Blood Pressure Monitoring in Moderate Hypertensive Patients in a Randomized, Controlled, Double-Blind Study
试验速览
- 阶段
- 4 期
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- 24 hours mean, determinated through ABPM; diastolic mean after 4 weeks of losartan 100mg/amlodipine 5mg and valsartan 160mg/amlodipine 5mg treatment
研究概览
简要总结
Hypertensive patients with moderate hypertension have a risk to develop cardiovascular events of 15-20% over a period of 10 years. It is important to reach quickly the advised target, but often this result can be obtained with a combination therapy. Some evidences demonstrate sartans and calcium channels blockers can be very useful and safe, but it is also important to verify which association can give side effects or give some pharmacokinetic interactions that can negatively influence the clinical combination efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diastolic blood pressure in sitting position 100 to 109 mmHg and systolic blood pressure > 140 mmHg at the end of the selection period
排除标准
- •type 2 diabetes mellitus
- •heart failure
- •AMI in the previous 6 months
- •angina pectoris
- •secondary hypertension
- •malignant hypertension
- •women child-bearing potential
- •women who are pregnant and lactating
- •suspected history of allergy to the sartans or calcium channels blockers
研究组 & 干预措施
1
valsartan/amlodipine
干预措施: valsartan/amlodpine (Drug)
2
losartan/amlodpine
干预措施: losartan/amlodpine (Drug)
结局指标
主要结局
24 hours mean, determinated through ABPM; diastolic mean after 4 weeks of losartan 100mg/amlodipine 5mg and valsartan 160mg/amlodipine 5mg treatment
时间窗: after 4 weeks
次要结局
- 24 hours systolic mean, determinated through ABPM; day systolic and diastolic mean determinated through ABPM; night systolic and diastolic mean determinated through ABPM(after 4 weeks)