NCT00387517已完成3 期
An Eight-week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (150/25 mg and 300/25 mg) in Comparison With HCTZ 25 mg in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg Monotherapy
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
- 726
- 试验地点
- 3
- 主要终点
- Mean sitting diastolic blood pressure lowering effect at baseline, and week 8.
研究概览
简要总结
The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.
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 outpatients 18 years old or older.
- •Patients with a diagnosis of hypertension defined as follows:
- •Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= mmHg and < 110 mmHg at Visit
- •All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= 85 mmHg and < 110 mmHg at Visit
- •All patients must have a msDBP >= 90 mmHg and < 110 mmHg at Visit
- •Patients who are eligible and consent to participate in the study
排除标准
- •Severe hypertension (msDBP >= 110 mmHg and/or MSSBP >=180 mmHg).
- •Previous or current diagnosis of heart failure.
- •History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Mean sitting diastolic blood pressure lowering effect at baseline, and week 8.
次要结局
- Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8
- Safety and tolerability
- Proportion of patients achieving a blood pressure control target at week 8
研究者
研究点 (3)
Loading locations...
相似试验
已完成
4 期
Blood Pressure Lowering of Aliskiren Hydrochlorothiazide (HCTZ) Versus Amlodipine in Stage 2 Hypertension in African AmericansHypertensionNCT00739596Novartis Pharmaceuticals332
已完成
3 期
8-week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe HypertensionHypertensionNCT00327587Novartis2,279
已完成
3 期
Aliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus AmlodipineEssential HypertensionNCT01113047Novartis347
已完成
3 期
Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)Myocardial InfarctionNCT00414609Novartis820
已完成
3 期
Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mgHypertensionNCT00529451Novartis1,613