NCT01113047已完成3 期
An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With the Single Pill (SPC) Combination of Aliskiren 300 mg / Amlodipine 10 mg in Hypertensive Patients Not Adequately Respond to an Uptitrated 4 Week Therapy With the SPC of Olmesartan 40 mg / Amlodipine 10 mg, With a Potential Extension if Patients Still Not Adequately Respond With a 4 Week Therapy With the SPC Aliskiren 300 mg / Amlodipine 10 mg / HCTZ 12,5 mg
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
- 347
- 试验地点
- 1
- 主要终点
- Change in mean sitting diastolic blood pressure after 4 weeks of treatment
研究概览
简要总结
This study will assess the efficacy and safety of the single pill combination of Aliskiren and Amlodipine in patients with moderate hypertension not adequately responding to a single pill combination of Olmesartan and Amlodipine.
Further this study will also assess the efficacy and safety of a single pill combination of Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in patients with moderate hypertension not adequately responding to a single pill combination of Aliskiren and Amlodipine.
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
- •Essential hypertension stage II
- •Male and female patients
- •Age >= 18 years old
排除标准
- •Severe hypertension (systolic BP >= 180 mmHg, diastolic BP >= 110 mmHg
- •Poorly controlled diabetes mellitus or type 1 DM
- •History of myocardial infarction, stroke
- •Presence of heart failure
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Non responder Olmesartan/Amlodipine
Experimental
Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ
干预措施: Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ (Drug)
结局指标
主要结局
Change in mean sitting diastolic blood pressure after 4 weeks of treatment
时间窗: 4 weeks
次要结局
- Change in mean sitting diastolic blood pressure after 4 weeks of treatment with Aliskiren/Amlodipine/HCT(4 weeks)
- Change in mean sitting systolic blood pressure reduction after 4 weeks of treatment with Aliskiren/Amlodipine or after 4 weeks of treatment with Aliskiren/Amlodipine/HCT(4 weeks)
- Change in heart rate, pulse pressure, responder rates, normalization rates after 4 weeks of treatment with Aliskiren/Amlodipine or after 4 weeks of treatment with Aliskiren/Amlodipine/HCT(4 weeks)
研究者
研究点 (1)
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