NCT00171366已完成3 期
A Multicenter, Group Study to Evaluate the Safety and Efficacy of Amlodipine and Benazepril Administered in Combination Compared to Amlodipine Monotherapy in Hypertensive Patients Not Adequately Controlled With Amlodipine Alone
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
- 1,422
- 试验地点
- 2
- 主要终点
- Change from baseline in mean sitting diastolic blood pressure at week 6
研究概览
简要总结
Comparison of the safety and efficacy of the combination of amlodipine/Benazepril to amlodipine monotherapy in patients with non-essential hypertension, not controlled on amlodipine alone.
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
- •Outpatients 18 years of age or older.
- •Male or female patients are eligible. Female patients must be either post-menopausal for one year or surgically sterile, or using effective, contraceptive methods such as barrier method with spermicide, or an intrauterine device.
- •Patients with essential hypertension as measured by a validated device
排除标准
- •Severe hypertension (DBP > 115 mmHg diastolic and/or SBP > 180 mmHg systolic).
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change from baseline in mean sitting diastolic blood pressure at week 6
次要结局
- Change from baseline in mean sitting systolic blood pressure at week 6
- Change from week 2 in mean sitting diastolic and systolic blood pressure at week 6
- Diastolic response rate at week 6. Patients were considered responders if they had a mean sitting diastolic blood pressure of < 90 mmHg or a >= 10 mm Hg decrease compared to baseline.
- Change from baseline in 24 hour diastolic and systolic blood pressure at week 6
- Change from baseline in 24 hour diastolic and systolic blood pressure at peak which is defined as the lowest hourly blood pressure mean and the average of the hourly means from 4 to 6 hours post dose at week 6
研究者
研究点 (2)
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