NCT01134393已完成3 期
A Prospective, Open-label TElmisartan/AMlodipine Single Pill STudy to Assess the Efficacy in Patients With Essential Hypertension"..."
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 47
- 主要终点
- Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.
研究概览
简要总结
The general aim of this trial to determine the efficacy as measured by the percentage of patients reaching blood pressure goal at the end of the treatment period at 12 weeks. In-clinic blood pressures, home blood pressures and safety will be carefully monitored.
详细描述
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（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
研究组 & 干预措施
telmisartan/amlodipine
Experimental
start low dose and uptitrate to high dose on the basis of blood pressure goal
干预措施: telmisartan/amlodipine (Drug)
结局指标
主要结局
Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.
时间窗: 12 weeks
Achieving BP control is defined as SBP\<140 mmHg and DBP\<90 mmHg.
次要结局
- BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.(4 and 8 weeks)
- BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).(Week 12)
- Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP(weeks 4, 8 and 12)
- Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate(weeks 4, 8 and 12)
- Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure(weeks 4, 8 and 12)
- DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements(weeks 4, 8 and 12)
- Percentage of Patients in Blood Pressure Categories Over Time(weeks 4, 8 and 12)
- DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements(weeks 4, 8 and 12)
- Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time(weeks 4 and 8)
研究者
研究点 (47)
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