NCT02242838已完成不适用
Post-Marketing Surveillance of Micardis® (Telmisartan) Special Drug Use-results Survey on Long-term Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,336
- 主要终点
- Change in Mean systolic blood pressure (SBP)
研究概览
简要总结
The primary objective of this survey is to prospectively investigate safety and efficacy in patients with hypertension treated with telmisartan in proper use in medical practice over a long period
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hypertension
排除标准
- •Patients with the following conditions
- •Patients with a history of hypersensitivity of this product
- •Women in pregnancy (included the possibility of pregnancy)
- •Patients with severe biliary obstructive disorders or severe hepatic insufficiency
研究组 & 干预措施
Hypertensive patients
干预措施: Telmisartan (Drug)
结局指标
主要结局
Change in Mean systolic blood pressure (SBP)
时间窗: up to 1 year
Number of patients with adverse drug reactions
时间窗: up to 1 year
Change in Mean diastolic blood pressure (DBP)
时间窗: up to 1 year
Incidence of adverse drug reactions
时间窗: up to 1 year
classified by Medical Dictionary for Regulatory Activities (MedDRA) terminology
次要结局
- Overall assessment of efficacy by investigator on 4-point scale(at 3 month, after 1 year)
- Change in pulse rate(up to 1 year)
研究者
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