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临床试验/NCT00219063
NCT00219063已完成3 期

A 26 Week, Double-blind, Randomized, Multicenter, Parallel Group, Active-controlled Study Comparing Aliskiren to Ramipril With Optional Addition of Hydrochlorothiazide, Followed by a 4 Week Double-blind, Randomized, Placebo-controlled Withdrawal in Patients With Essential Hypertension

Novartis1 个研究点 分布在 1 个国家目标入组 844 人开始时间: 2005年2月1日最近更新:
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
844
试验地点
1
主要终点
Change from baseline in diastolic blood pressure after 26 weeks

研究概览

简要总结

To compare the aliskiren regimen versus the ramipril regimen on reduction in Blood Pressure.

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
  • History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion exclusion criteria also apply.

结局指标

主要结局

Change from baseline in diastolic blood pressure after 26 weeks

次要结局

  • Change from baseline in diastolic blood pressure after 6 weeks and 12 weeks
  • Change from baseline in systolic blood pressure after 26 weeks
  • Change from baseline in systolic blood pressure after 6 weeks and 12 weeks
  • Blood pressure control target of < 140/90 mmHg after 6, 12, and 26 weeks

研究者

发起方
Novartis
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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