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临床试验/NCT00262236
NCT00262236已完成3 期

A Twelve-week, Randomized, Double-blind, Parallel-group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Atenolol in Patients With Essential Hypertension

Novartis2 个研究点 分布在 2 个国家目标入组 693 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
693
试验地点
2
主要终点
Change from baseline in diastolic blood pressure after 12 weeks

研究概览

简要总结

This is a study for people diagnosed with hypertension to compare the safety and effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in the study for 12 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

  • Outpatients 18 years of age and older.
  • Patients with essential hypertension.

排除标准

  • Severe hypertension, Current diagnosis of heart failure, History or evidence of a secondary form of hypertension, Participation in any investigational drug study within one month of planned participation,
  • Other protocol-defined inclusion/exclusion criteria may apply

结局指标

主要结局

Change from baseline in diastolic blood pressure after 12 weeks

次要结局

  • Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 12 weeks
  • Blood pressure of < 140/90 mmHg after 12 weeks
  • Change from baseline in systolic blood pressure after 12 weeks

研究者

发起方
Novartis
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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