Azilsartan/Amlodipine (Zacras) Combination Tablets LD & HD Specified Drug-use Survey "Long-term Use Survey"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,090
- 主要终点
- Percentage of Participants Who Had One or More Adverse Events
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/amlodipine combination tablets Low Dose (LD) & High Dose (HD) (Zacras Combination Tablets LD & HD) in hypertensive patients in daily medical practice.
详细描述
This survey was designed to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets LD & HD (Zacras Combination Tablets LD & HD) in hypertensive patients in daily medical practice.
For adults, one azilsartan/amlodipine combination tablet (20 mg/2.5 mg [for LD tablets] or 20 mg/5 mg [for HD tablets] of azilsartan/amlodipine) is administered orally once daily. Azilsartan/amlodipine combination tablets should not be used as the first-line drug for the treatment of hypertension.
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
- •Hypertensive patients who meet any of the following conditions, [1] to [3], are excluded from the survey:
- •Patients with a history of hypersensitivity to any of the ingredients of azilsartan/amlodipine combination tablets or other dihydropyridine drugs
- •Patients who are pregnant or having possibilities of being pregnant
- •Diabetic patients taking aliskiren fumarate (excluding those with markedly poor blood pressure control even after other antihypertensive treatment)
研究组 & 干预措施
Azilsartan/Amlodipine
Azilsartan/Amlodipine combination tablets (20 mg/2.5 mg or 20 mg/5 mg), orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care.
干预措施: Azilsartan/Amlodipine (Drug)
结局指标
主要结局
Percentage of Participants Who Had One or More Adverse Events
时间窗: Up to Month 12
次要结局
- Diastolic Office Blood Pressure(Baseline, Month 1, and final assessment point (up to Month 12))
- Systolic Office Blood Pressure(Baseline, Month 1, and final assessment point (up to Month 12))