Unisia Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,409
- 主要终点
- Number of Participants Who Experience at Least One Adverse Events
研究概览
简要总结
The purpose of this survey is to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) low dose (LD), high dose (HD) in participants with hypertension in the normal clinical setting.
详细描述
This special drug use surveillance was designed to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) in participants with hypertension in the routine clinical setting.
The usual adult dosage is one tablet (8 mg/2.5 mg or 8 mg/5 mg as candesartan cilexetil/amlodipine besilate) administered orally once daily.
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
- •Participants with hypertension
排除标准
- •Participants in whom Candesartan cilexetil/Amlodipine besilate is contraindicated [Contraindications]
- •Participants with a history of hypersensitivity to the ingredients of Candesartan cilexetil/Amlodipine besilate or any other dihydropyridine formulations
- •Women who are pregnant or of child-bearing potential
研究组 & 干预措施
Candesartan cilexetil/Amlodipine besilate
8 milligram (mg)/2.5 mg or 8 mg/5 mg, orally, once daily
干预措施: Candesartan cilexetil/Amlodipine besilate (Drug)
结局指标
主要结局
Number of Participants Who Experience at Least One Adverse Events
时间窗: Up to 12 Months
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 Diastolic Blood Pressure (DBP) at Final Assessment(Baseline and final assessment (up to 12 Months))
- Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment(Baseline and final assessment (up to 12 Months))
- Changes From Baseline in Pulse Rate at Final Assessment(Baseline and final assessment (up to 12 Months))
- Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment(Baseline and final assessment (up to 12 Months))