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临床试验/NCT00219193
NCT00219193已完成3 期

An Eight Week, Multicenter Study to Evaluate Efficacy and Safety of the Triple Combo of Aliskiren /Valsartan/HCTZ (300/320/25 mg), Compared to the Double Combos of Aliskiren/HCTZ (300/25 mg) or Valsartan/HCTZ (320/25 mg) in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg

Novartis3 个研究点 分布在 2 个国家目标入组 641 人开始时间: 2005年10月1日最近更新:
适应症
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试验速览

阶段
3 期
状态
已完成
发起方
Novartis
入组人数
641
试验地点
3
主要终点
Change from baseline in diastolic blood pressure after 8 weeks

研究概览

简要总结

To evaluate the blood pressure lowering effect and safety of the triple combination aliskiren / valsartan / HCTZ (300/320/25 mg) in patients with essential hypertension not adequately responsive to HCTZ 25 mg

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

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
  • Other protocol-defined exclusion criteria may apply.

结局指标

主要结局

Change from baseline in diastolic blood pressure after 8 weeks

次要结局

  • Change from baseline in standing blood pressure after 4 weeks and 8 weeks
  • Change from baseline in systolic and diastolic blood pressure after 4 weeks and 8 weeks
  • Achieve blood pressure control target of < 140/90 mmHg after 8 weeks

研究者

发起方
Novartis
申办方类型
Industry
责任方
Sponsor

研究点 (3)

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