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)
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
- 否
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
研究点 (97)
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