Azilsartan Tablets Special Drug Use Surveillance: Long-term Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,437
- 主要终点
- Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
研究概览
简要总结
The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical setting.
详细描述
This surveillance was designed to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in hypertensive patients in daily medical practice.
The usual dosage for adult is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the patient's age and condition. The maximum daily dose is 40 mg.
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
- •Hypertensive patients
排除标准
- •Patients with a history of hypersensitivity to any of the ingredients of Azilsartan
- •Patients who are pregnant or having possibilities of being pregnant
研究组 & 干预措施
Azilsartan
Azilsartan 20 mg - 40 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
干预措施: Azilsartan (Drug)
结局指标
主要结局
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
时间窗: Up to 12 Months
ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
次要结局
- Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point(Baseline, Month 1 and final assessment (up to 12 Months))
- Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point(Baseline, Month 1 and Final assessment (up to 12 Months))