Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,882
- 主要终点
- Evaluation of participants with Adverse Events for Safety purpose in real practice
研究概览
简要总结
This study is a post-marketing surveillance in Japan, and it is a local prospective, company sponsored and observational study of patient who have been treated by Adalat CR for hypertension with diabetes and/or chronic kidney disease. The objective of this study is to assess safety and efficacy profile of using Adalat CR in real clinical practice. A total 2,000 patients will be recruited and be observed for 6 months. Then, patient of whom microalbumin urea and serum creatinine are continuously monitored are additionally followed for 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who are administered with Adalat CR for hypertension with diabetes and/or chronic kidney disease (CKD)
排除标准
- •CKD with stage 5
- •CDK with dialysis
研究组 & 干预措施
Group 1
干预措施: Nifedipine (Adalat CR, BAYA1040) (Drug)
结局指标
主要结局
Evaluation of participants with Adverse Events for Safety purpose in real practice
时间窗: After 6 months
General evaluation of patient concerning efficacy of AdalatCR treatment in real practice
时间窗: After 6 months
次要结局
- Blood pressure, Pulse rate(After 6 months)
- Overall evaluation(After 6 months)
- Clinical test values, in specially, microalbumin urea and serum creatinine(After 6 months)