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临床试验/NCT00240474
NCT00240474已完成4 期

A Comparison of Telmisartan 80 mg + Hydrochlorothiazide 12.5 mg With Amlodipine 10 mg + Hydrochlorothiazide 12.5 mg in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension. A Prospective, Randomised, Open-label, Blinded End-point Evaluation. (ATHOS Study)

Boehringer Ingelheim97 个研究点 分布在 9 个国家目标入组 1,000 人开始时间: 2002年12月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
1,000
试验地点
97
主要终点
Change from baseline in the last 6-hour mean (relative to dose time) in SBP as measured by 24-hour ABPM at the end-of-study visit

研究概览

简要总结

The primary objective of this study was test non-inferiority of telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg in comparison to amlodipine 10 mg + HCTZ 12.5 mg in reducing ambulatory systolic blood pressure (SBP) in the last 6 hours of the 24-hour dosing interval (determined by ambulatory blood pressure monitoring: ABPM) in elderly patients with predominantly systolic hypertension.

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
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change from baseline in the last 6-hour mean (relative to dose time) in SBP as measured by 24-hour ABPM at the end-of-study visit

时间窗: 14 weeks

次要结局

  • Proportion of patients achieving a target response in SBP(14 weeks)
  • Proportion of patients achieving normal blood pressure(14 weeks)
  • Change from baseline in trough seated SBP(14 weeks)
  • Change from baseline in pulse pressure (PP) in the last six hours of the 24-hour dose period(week 8 and 14)
  • Change from baseline in SBP in the last six hours of the 24-hour dose period (as measured by 24-hour ABPM).(8 weeks)
  • Proportion of patients achieving SBP control(14 weeks)
  • Change from baseline in patient HRQL as measured by the Psychological General Well-Being (PGWB) index.(week 8 and 14)
  • Change from baseline in trough seated DBP(14 weeks)
  • Change from baseline in DBP in the last six hours of the 24-hour dose period(week 8 and 14)
  • Change from baseline SBP and DBP for other time intervals ( i.e. 24-hour mean, morning mean (06:00-11:59), daytime mean (06:00-21:59), and night-time mean (22:00-05:59))(week 8 and 14)
  • Proportion of patients achieving high-normal blood pressure(14 weeks)
  • Safety and tolerability of the combination of telmisartan 80 mg and HCTZ 12.5 mg compared with amlodipine 10 mg and HCTZ 12.5 mg(14 weeks)

研究者

申办方类型
Industry

研究点 (97)

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