Azilva Tablets Special Drug Use Surveillance "Hypertension Complicated by Diabetes "
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 387
- 主要终点
- Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of azilsartan tablets (Azilva Tablets) in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be sufficiently reduced by monotherapy with angiotensin II receptor blockers (ARBs) other than azilsartan, in routine clinical practice
详细描述
This study was designed to evaluate the efficacy of azilsartan tablets (Azilva Tablets) in patients with hypertension complicated by diabetes mellitus whose blood pressure cannot be sufficiently reduced by monotherapy with ARBs, other than azilsartan, in daily medical practice.
Patient enrollment will be started on April 1, 2014. The usual dosage for adults is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the participant'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
- •Patients with hypertension who meet all the following criteria will be enrolled:
- •Patients who has complications of diabetes mellitus
- •Patients who is on monotherapy with ARBs (other than azilsartan) as antihypertensive treatment (Patients who have continued monotherapy with the same ARB product for at least 8 weeks at the time of Step-1* of participant enrollment and will continue such treatment until the first administration of Azilsartan Tablets)
- •Patients who has a systolic blood pressure of ≥ 130 millimeter of mercury (mmHg) and/or diastolic blood pressure of 80 ≥ mmHg at the examination performed at the medical institution
- •Patients who is an outpatient
- •Patient who keeps a regular lifestyle and whose usual waking time is between 4 a.m. and 9:30 a.m.
- •*For this surveillance, participant enrollment will be performed in two divided steps: Step-1 (at hospital visit before prescription of Azilsartan Tablets) and Step-2 (at the time of prescription of Azilsartan Tablets).
排除标准
- •Patients with contraindications to azilsartan
研究组 & 干预措施
Azilsartan at a dose of 20 to 40 mg, orally, once daily
Azilsartan tablets
干预措施: Azilsartan (Drug)
结局指标
主要结局
Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24)
时间窗: From baseline up to final assessment point (up to Week 24)
Reported data were changes from baseline in blood pressure (SBP and DBP) measured at home right after waking up and at bedtime.
Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution
时间窗: From baseline up to final assessment point (up to Week 24)
Reported data were changes from baseline in blood pressure (systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) measured at the medical institution.
次要结局
- Changes From Baseline in Hemoglobin A1c (HbA1c) on Final Assessment Point (up to Week 24) at the Medical Institution(From baseline up to final assessment point (up to Week 24))
- Percentage of Participants Who Had One or More Adverse Events(Up to Week 24)
- Changes From Baseline in Creatinine-adjusted Urinary Albumin Level on Final Assessment Point (up to Week 24) at the Medical Institution(From baseline up to final assessment point (up to Week 24))
- Changes From Baseline in Pulse Rate on Final Assessment Point (up to Week 24) at the Medical Institution(From baseline up to final assessment point (up to Week 24))