Pharmacovigilance and Patient Compliance in Hypertensive Patients. Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,333
- 主要终点
- Assessment of changes in heart rate
研究概览
简要总结
Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal conditions of use after market launch and to supplement the present data on the safety of telmisartan. Furthermore to assess effectiveness of a single dose of telmisartan per day to control blood pressure for 24 hours, especially during the last few hours of the dosage interval. Additionally to evaluate compliance with treatment, as an indirect measurement, and to confirm the efficacy and possible risks associated with treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex over the age of 18 years suffering from non-secondary essential hypertension with values of at least 90 mmHg (diastolic) and 140 mmHg (systolic)
排除标准
- •corresponding to the contraindications listed in the summary of product characteristics of the drug
研究组 & 干预措施
Patients with non-secondary, essential hypertension
干预措施: Telmisartan (Drug)
结局指标
主要结局
Assessment of changes in heart rate
时间窗: Baseline, up to 8 weeks after start of treatment
Assessment for patients with changes in laboratory values
时间窗: Baseline, up to 8 weeks after start of treatment
Number of patients with adverse events
时间窗: Up to 8 weeks after start of treatment
次要结局
- Changes in mean systolic and diastolic blood pressure values(Baseline, up to 8 weeks after start of treatment)
- Evaluation of treatment compliance as percentage of tablets planned(Up to 8 weeks after start of treatment)