NORVASC10MG DRUG USE INVESTIGATION
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14,141
- 主要终点
- Changes in Ambulatory Systolic Blood Pressure From Baseline
研究概览
简要总结
In this survey, to collect the safety and efficacy information in the subjects who have been treated with amlodipine 5mg at least 4 weeks in daily practice.
详细描述
All the subjects whom an investigator prescribes Amlodipine (Norvasc®) 10mg Tablet should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects who have been treated with amlodipine 5mg at least 4 weeks
- •The subjects who had not achieved target BP
排除标准
- •Subjects who have been prescribed amlodipine (Norvasc®) 10mg Tablet before
研究组 & 干预措施
Amlodipine 10mg Tablet
Subjects taking Amlodipine 10mg Tablet.
干预措施: Amlodipine (Drug)
结局指标
主要结局
Changes in Ambulatory Systolic Blood Pressure From Baseline
时间窗: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)
Changes in ambulatory systolic blood pressure (SBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.
Changes in Ambulatory Diastolic Blood Pressure From Baseline
时间窗: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)
Changes in ambulatory diastolic blood pressure (DBP) from baseline were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.
The Achievement Rate to Ambulatory Blood Pressure Goal
时间窗: 4, 8, 12 weeks and last day of observation period (average of 14.76 weeks)
The achievement rates to ambulatory blood pressure goal specified in the Japanese guidelines (JSH2009) were calculated at weeks 4, 8, and 12 as well as on the last day of the observation period.
Number of Participants With Treatment Related Adverse Events
时间窗: Last day of observation period (average of 14.76 weeks)
A treatment-related adverse event was any untoward medical occurrence attributed to Amlodipine Tablets or Amlodipine OD Tablets at 10 mg/day. Relatedness to Amlodipine Tablets or Amlodipine OD Tablets was assessed by the investigator and sponsor (Pfizer Japan Inc.).
次要结局
- Number of Participants With Adverse Events Listed in Japanese Package Insert(Last day of observation period (average of 14.76 weeks))
- Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Diabetes Mellitus)(Last day of observation period (average of 14.76 weeks))
- Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Metabolic Syndrome)(Last day of observation period (average of 14.76 weeks))
- Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (Antihypertensive)(Last day of observation period (average of 14.76 weeks))
- Changes in Home Systolic Blood Pressure From Baseline(4, 8, 12 weeks and last day of observation period (average of 14.76 weeks))
- Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Angina Pectoris)(Last day of observation period (average of 14.76 weeks))
- Number of Participants With Treatment-Related Adverse Events: With/Without Complication (Dyslipidaemia)(Last day of observation period (average of 14.76 weeks))
- Number of Treatment Related Adverse Events Unlisted in Japanese Package Insert(Last day of observation period (average of 14.76 weeks))
- Number of Participants With Treatment-Related Adverse Events: With/Without Concomitant Drug (ARB)(Last day of observation period (average of 14.76 weeks))
- Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Chronic Kidney Disease)(Last day of observation period (average of 14.76 weeks))
- Number of Participants Who Achieved the Target Blood Pressure: With/Without Complication (Myocardial Infarction)(Last day of observation period (average of 14.76 weeks))
- Changes in Home Diastolic Blood Pressure From Baseline(4, 8, 12 weeks and last day of observation period (average of 14.76 weeks))
- Number of Participants With Treatment-Related Adverse Events: With/Without Complication(s)(Last day of observation period (average of 14.76 weeks))
- Number of Participants With Treatment-Related Adverse Events: Male vs. Female(Last day of observation period (average of 14.76 weeks))
- Number of Participants Who Achieved the Target Blood Pressure: Ambulatory Systolic Blood Pressure(Last day of observation period (average of 14.76 weeks))
- The Achievement Rate to Home Blood Pressure Goal(4, 8, 12 weeks and last day of observation period (average of 14.76 weeks))