The Special Drug Use-results Survey on Long-term Use of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed Dose Combination Tablets in Patients With Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 676
- 试验地点
- 1
- 主要终点
- Frequency of Patients With Any Suspected Adverse Drug Reactions
研究概览
简要总结
Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio® Combination Tablets treatment in patients with hypertension
详细描述
Non-interventional study based on newly collected data. The study will consist of a baseline visit and follow-up visits at Week 4, 8, 12, 24, 36 and 52 for patients who have newly initiated Micatrio® Combination Tablets. The patients will be followed up until discontinuation of Micatrio® Combination Tablets treatment or the end of study.
All patients administrated Micatrio® Combination Tablets after the launch at the sites contracted with the sponsor will be registered.
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
- 12 Years 至 —（Child, 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
T80/A5/H12.5 FDC
Patients with hypertension
干预措施: T80/A5/H12.5 FDC (Drug)
结局指标
主要结局
Frequency of Patients With Any Suspected Adverse Drug Reactions
时间窗: from first intake of Micatrio combination tablet until last intake +1 day (week 52)
An Adverse drug reaction (ADR) is defined as an AE for which either the investigator or the sponsor (or both) assess the causal relationship to Micatrio Combination Tablets as related. The frequency of patients with any suspected ADR is presented as total number of participants with an ADR reported.
次要结局
- Change From Baseline in Clinic Systolic Blood Pressure at Week 52(At baseline and week 52)
- Change From Baseline in Clinic Diastolic Blood Pressure at Week 52(At baseline and week 52)