NCT00219180已完成3 期
An 8-week Multi-center, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren (150 mg and 300 mg) Administered Alone and in Combination With Valsartan (160 mg and 320 mg) in Patients With 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
- 1,797
- 试验地点
- 3
- 主要终点
- Change from baseline in diastolic blood pressure after week 8
研究概览
简要总结
To evaluate the efficacy and safety of aliskiren alone and in combination with valsartan given to 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
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
- •Patients with essential hypertension
- •Patients who are eligible and able to participate in the study
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 exclusion criteria may apply.
结局指标
主要结局
Change from baseline in diastolic blood pressure after week 8
次要结局
- Change from baseline in systolic blood pressure after week 8
- Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 and 8 weeks
- Blood pressure control target of < 140/90 mmHg after 4 and 8 weeks
- Evaluate 24-hour ambulatory blood pressure monitoring in a subset of patients
研究者
研究点 (3)
Loading locations...
相似试验
已完成
4 期
8 Weeks Study to Evaluate the Efficacy and Safety of Valsartan in Combination With Aliskiren Compared to Valsartan Alone in Patients With Stage 2 HypertensionStage 2 HypertensionNCT00809926Novartis451
已完成
3 期
A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.HypertensionNCT00386607Novartis601
已完成
3 期
A Clinical Study to Compare the Safety and Efficacy of an Aliskiren-based Regimen With a Lisinopril Based Regimen in Patients With Severe HypertensionHypertensionNCT00219050Novartis180
已完成
3 期
Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential HypertensionLeft Ventricular HypertrophyOverweightHypertensionNCT00219141Novartis Pharmaceuticals460
已完成
3 期
Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine AloneHypertensionNCT00778921Novartis847