NCT00872586已完成3 期
A Randomized, Double-blind, Double-dummy, Multicenter Clinical Trial to Evaluate the Additional Efficacy and Safety of Olmesartan Medoxomil 20mg / Hydrochlorothiazide 12.5mg in the Treatment of Chinese Patients With Mild to Moderate Essential Hypertension, Who Fail to Attain the Blood Pressure Goals With Olmesartan Medoxomil 20mg Monotherapy
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
- 304
- 主要终点
- Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups.
研究概览
简要总结
This study is designed to evaluate the additional efficacy and safety of olmesartan medoxomil/hydrochlorothiazide in the treatment of Chinese patients with mild to moderate essential hypertension, who fail to attain the blood pressure goals with olmesartan medoxomil monotherapy
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
- •At Visit 3, mean seated diastolic blood pressure (SeDBP) ≥ 95 mmHg and < 110 mmHg, AND mean seated systolic blood pressure (SeSBP) ≥140 mmHg and < 180 mmHg
- •At Visit 4, mean SeDBP ≥ 90 mmH
- •No significant disorder in blood, kidney, liver, cardiovascular system or endocrinology system
排除标准
- •Patients with known or suspect secondary hypertension
- •Unstable angina
- •History of acute myocardial infarct, or PTCA or surgical cardiac procedures 3 months before entry into this study
- •Prior or current congestive heart failure (NYHA grade III or IV), hypertrophic obstructive cardiomyopathy, valvular disease or rheumatic heart disease
- •Arrhythmia of clinical significance
- •Bilateral renal artery stenosis, isolated renal artery stenosis, post kidney transplantation
- •Acute glomerular nephritis
- •Gout sufferers, even with the normal serum uric acid at entry
- •Retinal hemorrhage /exudate
- •Type 1 diabetes mellitus
- •Uncontrolled type 2 diabetes mellitus
- •Hypovolemia
- •Patients with autoimmune disease
研究组 & 干预措施
1
Experimental
Olmesartan medoxomil and hydrochlorothiazide
干预措施: olmesartan medoxomil + hydrochlorothiazide (Drug)
2
Active Comparator
olmesartan medoxomil
干预措施: olmesartan medoxomil (Drug)
结局指标
主要结局
Mean change of trough seated diastolic blood pressure from baseline to Week 12 between the two treatment groups.
时间窗: Baseline to12 weeks
次要结局
- The mean change of trough seated systolic blood pressure from Week 5 to Week 12 between the two treatment groups(8 weeks (week 5 to week 12))
- The mean change of trough seated diastolic blood pressure and seated systolic blood pressure from Week 5 to Week 9 between the two treatment groups(5 weeks (Week 5 to week 9))
- The response rate in the two treatment groups from baseline to Week 9(Baseline to 9 weeks)
- The response rate in the two treatment groups from baseline to Week 12(Baseline to 12 weeks)
研究者
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