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临床试验/NCT00260923
NCT00260923已完成3 期

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing an Eight-week Treatment of Aliskiren 75 mg, 150 mg and 300 mg to Placebo in Patients With Essential Hypertension

Novartis3 个研究点 分布在 2 个国家目标入组 641 人开始时间: 2005年11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
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

This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks

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

  • Male and female outpatients 18 years of age and older
  • 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 may apply

结局指标

主要结局

Change from baseline in diastolic blood pressure after 8 weeks

次要结局

  • Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 8 weeks
  • Change from baseline in systolic blood pressure 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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