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临床试验/NCT00170963
NCT00170963已完成3 期

Valsartan/Amlodipine 160/5 mg or 160/10 mg Versus Valsartan 160 mg Alone for 8 Weeks in Hypertensive Patients Who Are Not Adequately Controlled on Valsartan 160 mg Monotherapy

Novartis2 个研究点 分布在 2 个国家目标入组 1,018 人开始时间: 2004年10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
1,018
试验地点
2
主要终点
Change from baseline in diastolic blood pressure after 8 weeks

研究概览

简要总结

This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication

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 uncomplicated, essential hypertension

排除标准

  • Severe hypertension
  • History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
  • Liver, kidney, or pancreas disease
  • Insulin dependent diabetes
  • Allergy to certain medications used to treat high blood pressure
  • 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 mean systolic blood pressure after 8 weeks
  • Decrease in diastolic blood pressure of at least 10 mmHg or diastolic blood pressure was less than 90 mmHg after 8 weeks
  • Diastolic blood pressure less than 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 (2)

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