NCT02242370已完成4 期
An Open-label Evaluation of the Effectiveness of MICARDIS® (Telmisartan) on Blood Pressure Control and Quality of Life in Patients With Essential Hypertension The MICARDIS COMMUNITY ACCESS TRIAL (MicCAT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,045
- 主要终点
- Change in diastolic blood pressure
研究概览
简要总结
Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to establish the effect on patient's quality of life scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 93 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Stage I essential Hypertension (diastolic blood pressure 90-99 mmHg, and/or systolic blood pressure 140-159 mmHg)
- •Signed informed consent form
排除标准
- •Females of childbearing potential
研究组 & 干预措施
Telmisartan low dose
Experimental
干预措施: Low dose of telmisartan (Drug)
Telmisartan high dose
Experimental
干预措施: High dose of telmisartan (Drug)
结局指标
主要结局
Change in diastolic blood pressure
时间窗: Pre-dose, up to 6 weeks after start of treatment
Change in systolic blood pressure
时间窗: Pre-dose, up to 6 weeks after start of treatment
Changes from baseline in the quality of life (QOL) scores by patient self-assessment
时间窗: Pre-dose, 6 weeks after start of treatment
次要结局
- Assessment of systolic blood pressure response rate(Up to 6 weeks after start of treatment)
- Change from baseline in pulse pressure(Pre-dose, up to 6 weeks after start of treatment)
- Assessment of blood pressure control rate(Up to 6 weeks after start of treatment)
- Assessment of diastolic blood pressure response rate(Up to 6 weeks after start of treatment)
- Number of patients with adverse events(Up to 6 weeks)
研究者
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