NCT00185172已完成3 期
Efficacy and Safety of Olmesartan: Reduction of Blood Pressure in the Treatment of Patients Suffering From 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
- 2,333
- 试验地点
- 8
- 主要终点
- To compare the efficacy on diastolic blood pressure of 40 mg olmesartan to a combination of 20 mg olmesartan and 12.5 mg hydrochlorothiazide in patients who are not sufficiently responding to treatment with 20 mg olmesartan.
研究概览
简要总结
To test the efficacy and safety of olmesartan in patients with 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
- Double (Participant, 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
- •Age: 18 (19 if required by local authorities) to 75 years
- •Males and females of any race. Female participants must take adequate contraceptive measures (oral contraceptives, I.U.D.), be post-menopausal or surgically sterilized
- •Essential hypertension: sitting DBP greater than or equal to 90 and less than 110 mmHg
- •Written Informed Consent
- •Mentally competent
- •Negative pregnancy test in women at a childbearing age at the beginning of the study
排除标准
- •Patients with known severe (World Health Organization (WHO) stage III, sitting DBP stable at greater than or equal to 110 mmHg), malignant or secondary hypertension
- •Patients who have had a myocardial infarction or percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the last 6 months
- •Patients with a history or current evidence of congestive heart failure
- •Bilateral renal artery stenosis
- •Severe renal insufficiency (serum creatinine greater than 200 micro mol/l)
- •Severe hepatic impairment or biliary obstruction
研究组 & 干预措施
1
Placebo Comparator
2 week placebo run-in
干预措施: placebo (Other)
2
Experimental
Olmesartan medoxomil tablets for 8 weeks
干预措施: olmesartan medoxomil (Drug)
3
Experimental
Olmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks
干预措施: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets (Drug)
结局指标
主要结局
To compare the efficacy on diastolic blood pressure of 40 mg olmesartan to a combination of 20 mg olmesartan and 12.5 mg hydrochlorothiazide in patients who are not sufficiently responding to treatment with 20 mg olmesartan.
时间窗: From week 8 to week 12
次要结局
- To assess the effects on systolic and diastolic blood pressure of 20 mg olmesartan, 40 mg olmesartan and the combination of 20 mg olmesartan with 12.5 mg hydrochlorothiazide at week 2, 4, 8 and 12.(12 weeks)
- To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan.(12 weeks)
研究者
研究点 (8)
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