Blopress Tablets Special Drug Use Surveillance 「Challenge - Quality Control」
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18,113
- 主要终点
- Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14
研究概览
简要总结
The purpose of this study is to gain an understanding of the actual use of candesartan cilexetil (Blopress) in patients with hypertension, and to examine the changes in parameters such as blood pressure.
详细描述
This special drug use surveillance was planned to gain an understanding of the actual use of candesartan cilexetil in the new anti-hypertensive treatment environment where angiotensin receptor blocker (ARB) combination drugs have become commercially available. The surveillance also investigated the background factors of patients continuing treatment with candesartan cilexetil and patients who switched from candesartan cilexetil to ARB combination drugs, as well as changes in parameters such as blood pressure.
The usual adult dosage of Candesartan cilexetil is 4 to 8 mg, administered orally, once daily. Meanwhile, treatment was to be started at 2 mg once daily in patients with renal impairment and the dose could be increased up to 8 mg as necessary.
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 under dialysis (planned)
- •Patients with a history of coronary artery disease/cerebrovascular disorder within 6 months
- •Patients with ≥ class III of the New York Heart Association (NYHA) classification functional classification of heart failure
- •Patients that have been prescribed with candesartan (this drug/Ecard/Unisia) in the past
- •Patients who are pregnant or may possibly become pregnant
研究组 & 干预措施
Candesartan Cilexetil tablets (2 to 12 mg)
Candesartan Cilexetil tablets (2 to 12 mg), orally, once daily for up to 3 months
干预措施: Candesartan Cilexetil (Drug)
结局指标
主要结局
Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14
时间窗: Baseline, Month 3, Last dose of Candesartan, and Last dose of ARB Combination Drug (up to Month 6)
Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan and last dose of ARB Combination Drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care.
Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14
时间窗: Baseline and Last dose of ARB Combination Drug (up to Month 6)
Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at last dose of diuretic-containing ARB combination drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to diuretic-containing ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care.
Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Calcium Channel Blocker (CCB)-Containing ARB Combination Drug Therapy at Week 14
时间窗: Baseline and Last dose of ARB Combination Drug (up to Month 6)
Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at last dose of ARB combination drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to calcium channel blocker (CCB)-containing ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care.
Changes in Clinic Blood Pressure in the Sitting Position
时间窗: Baseline, Month 3 and Last dose of Candesartan (up to Month 6)
Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan (up to Month 6) relative to baseline were reported.
Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14
时间窗: Baseline, Month 3 and Last dose of Candesartan (up to Month 6)
Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan (up to Month 6) relative to baseline in only participants who continued candesartan therapy at Week 14 were reported.
次要结局
- Number of Participants Who Experience at Least One Adverse Drug Reactions(Up to Month 3)