NCT00857285已完成3 期
A Multi-center, Double Blind, Efficacy, and Safety Study of the Oral Angiotensin II Receptor Blocker "Olmesartan Medoxomil" Versus "Losartan" 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
- 130
- 试验地点
- 3
- 主要终点
- Mean Change of Sitting dBP From Baseline to Week 12
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of oral administration of olmesartan medoxomil compared to losartan in subjects with mild to moderate 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diastolic BP 95 mm Hg - 114 mm Hg inclusive
- •No participation in any clinical trial for the last 3 months
排除标准
- •Secondary hypertension
- •Malignant hypertension
- •Severe arterial hypertension
- •Significant cardiovascular disease
- •History or clinical evidence of cerebrovascular, gastrointestinal, hematological, hepatic disease, myocardial infarction, or severe liver disorder
- •Clinical evidence of renal disease, poorly controlled diabetes, known malabsorption syndromes, psychiatric/emotional problems
研究组 & 干预措施
1
Experimental
olmesartan medoxomil
干预措施: olmesartan medoxomil (Drug)
2
Active Comparator
losartan potassium
干预措施: losartan potassium (Drug)
结局指标
主要结局
Mean Change of Sitting dBP From Baseline to Week 12
时间窗: Baseline to 12 weeks
The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12.
次要结局
未报告次要终点
研究者
研究点 (3)
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