NCT00856271已完成3 期
A Randomized, Double-blind, Double-dummy, Multi-center Study to Investigate the Safety and Efficacy of Olmesartan Medoxomil Compared With Losartan Potassium in Patients With Mild to Moderate Essential Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 287
- 主要终点
- Change of trough seated diastolic blood pressure from baseline to 8 weeks
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of olmesartan medoxomil compared with losartan potassium in patients with mild to moderate essential hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild to moderated essential hypertension (mean seated diastolic blood pressure ≥ 95 mmHg and <110 mmHg, mean seated systolic blood pressure < 180 mmHg)
- •able to give written informed consent
排除标准
- •known or suspected secondary hypertension
- •history of chronic hepatic diseases
- •obstructive hypertrophic cardiomyopathy/clinically significant valvular heart disease
- •cardiac arrhythmia
- •unstable angina pectoris
- •congestive heart insufficiency (New York Heart Association classification III-IV)
- •bilateral renal artery stenosis
- •isolated renal artery stenosis
- •post renal transplantation
- •history of acute myocardial infarction/percutaneous transluminal coronary angioplasty or heart surgery within three months before enrollment
- •retina bleeding/effusion
- •insulin dependent diabetes mellitus
- •uncontrolled non-insulin dependent diabetes mellitus
研究组 & 干预措施
2
Active Comparator
losartan potassium
干预措施: losartan potassium (Drug)
1
Experimental
olmesartan medoxomil
干预措施: olmesartan medoxomil (Drug)
结局指标
主要结局
Change of trough seated diastolic blood pressure from baseline to 8 weeks
时间窗: Baseline to 8 weeks
次要结局
未报告次要终点
研究者
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