NCT00402103已完成3 期
A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg / Amlodipine 10 mg in Patients With 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
- 发起方
- Novartis
- 入组人数
- 556
- 试验地点
- 3
- 主要终点
- Overall Percentage of Patients With Adverse Events
研究概览
简要总结
To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure [msDBP] ≥ 90 mmHg and < 110 mmHg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg at Visit 1 and Visit 4
- •For previously treated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg after 2 to 4 weeks of washout (Visit 4)
排除标准
- •Severe hypertension
- •History or evidence of a secondary form of hypertension
- •History of Hypertensive encephalopathy or cerebrovascular accident.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Aliskiren/Amlodipine
Experimental
干预措施: Aliskiren (Drug)
Aliskiren/Amlodipine
Experimental
干预措施: Amlodipine (Drug)
Aliskiren/Amlodipine/HCTZ
Experimental
干预措施: Aliskiren (Drug)
Aliskiren/Amlodipine/HCTZ
Experimental
干预措施: Amlodipine (Drug)
Aliskiren/Amlodipine/HCTZ
Experimental
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Overall Percentage of Patients With Adverse Events
时间窗: 52 weeks
次要结局
- Percentage of Patients Achieving a Blood Pressure Control Target of <140/90 mmHg(Baseline, Week 2, Week 10, Week 28 and Week 54)
- Change in Mean Sitting Diastolic Blood Pressure (msDBP)From Baseline to the Indicated Time Points(Baseline, Week 2, Week 4, Week 6, Week 10, Week 14, Week 28, Week 41 and Week 54)
- Percentage of Patients Achieving a Response in Mean Sitting Diastolic Blood Pressure (msDBP)(Baseline, Week 2, Week 10, Week 28 and Week 54)
研究者
研究点 (3)
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