NCT00367094已完成3 期
Efficacy and Safety of the Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Benazepril
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Change in diastolic blood pressure from baseline to week 8
研究概览
简要总结
This study will evaluate efficacy and safety data for benazepril/hydrochlorothiazide in adult Chinese patients with mild to moderate essential hypertension. Patients whose blood pressure is not adequately controlled with benazepril monotherapy during a 4 week run-in period will be randomly allocated to double blind treatment over 8 weeks with either a combination of benazepril/hydrochlorothiazide per day or continuation of benazepril per day.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, age 18 or older
- •Given informed consent
- •Diagnosed as having mild to moderate essential hypertension
排除标准
- •Severe hypertension
- •Significant preexisting cardiovascular and cerebrovascular disease
- •Diabetes mellitus type 1 or poorly controlled diabetes mellitus type II
- •Advanced renal impairment
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Change in diastolic blood pressure from baseline to week 8
次要结局
- Change in systolic blood pressure from baseline to week 8
- Proportion of patients with blood pressure less than 140/90 mmHg at week 8
- Ambulant blood pressure monitoring profiles at baseline and week 8
研究者
研究点 (1)
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