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临床试验/NCT00170989
NCT00170989已完成3 期

Comparison of the Combination of Valsartan 320 mg Plus Hydrochlorothiazide 12.5 mg and Valsartan 320 mg Plus Hydrochlorothiazide 25 mg to Valsartan 320 mg in Mild to Moderate Hypertensive Patients Not Adequately Controlled With Valsartan 320 mg

Novartis2 个研究点 分布在 2 个国家目标入组 2,714 人开始时间: 2004年9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
2,714
试验地点
2
主要终点
Change from baseline in diastolic blood pressure from baseline 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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with mild to moderate 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 from baseline after 8 weeks

次要结局

  • Change from baseline in systolic blood pressure from baseline after 8 weeks
  • Change from baseline in standing systolic and diastolic blood pressure after 8 weeks
  • Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic pressure after 8 weeks
  • Diastolic blood pressure less than 90 mmHg after 8 weeks
  • Adverse events and serious adverse events at 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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