NCT00327587已完成3 期
An 8-week, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Valsartan/HCTZ/Amlodipine Compared to Valsartan/HCTZ, Valsartan/Amlodipine, and HCTZ/Amlodipine in Patients With Moderate to Severe Hypertension.
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
- 2,279
- 试验地点
- 2
- 主要终点
- Change from baseline diastolic blood pressure after 8 weeks
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe 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
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of moderate to severe hypertension (MSDBP ≥ 100 mmHg and < 120 mmHg, MSSBP ≥ 145 mmHg and < 200 mmHg).
排除标准
- •Patients on two or more antihypertensive drugs with MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg at Visit
- •Patients on three or more antihypertensive drugs with MSDBP ≥ 90 mmHg and < 110 mmHg, and/or MSSBP ≥ 140 mmHg and < 180 mmHg at Visit
- •Patients on four or more antihypertensive drugs at Visit
- •Arm circumference > 42 cm for patients participating in ABPM.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change from baseline diastolic blood pressure after 8 weeks
Change from baseline systolic blood pressure after 8 weeks
次要结局
- Blood pressure less than 140/90 mmHg after 8 weeks
- Systolic blood pressure less than 140 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks
- Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease after 8 weeks or systolic blood pressure less than 140 mmHg or at least a 15 mmHg decrease after 8 weeks
- Ambulatory blood pressure and standing systolic and diastolic blood pressure measurements
- Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 8 weeks
研究者
研究点 (2)
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