A Post Marketing Observational Study to Investigate the Efficacy, Safety, Tolerability and the Effect on Quality of Life of Telmisartan (Micardis) and Telmisartan With HCTZ (Micardis Plus) in Patients With Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,095
- 试验地点
- 11
- 主要终点
- Change in SBP (Systolic Blood Pressure)
研究概览
简要总结
An observational study to investigate the efficacy, safety, tolerability and the effect on quality of life of Telmisartan (Micardis) and Telmisartan with HCTZ (Micardis Plus) in patients with hypertension
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- 否
入选标准
- •Ability to provide written/verbal informed consent in accordance with GCP (Good Clinical Practice) and local legislation
- •Patients aged 18 ~ under 80
- •Hypertension as described below:
- •Newly diagnosed patients with hypertension
- •Patients with current antihypertensive therapy
排除标准
- •Female subjects who are breastfeeding, pregnant or who plan to be pregnant during the study
- •Known or suspected secondary hypertension(e.g. pheochromocytoma)
- •Patients who have been treated with telmisartan prior to the acquisition of informed consent (including verbal informed consent)
结局指标
主要结局
Change in SBP (Systolic Blood Pressure)
时间窗: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
The change of the mean SBP
Change in DBP (Diastolic Blood Pressure)
时间窗: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
The change of the mean DBP
Change in WHO-QOL (WHO-Quality Of Life)
时间窗: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
World Health Organization-Quality Of Life (WHO-QOL), change in quality of life was assessed. Best value=130.0 (highest quality of life), worst value=0.0 (lowest quality of life)
次要结局
- Change in VAS (Visual Analog Scale)(between baseline (visit 1) and after 12 weeks of treatment (visit 3))