Hypertension
Conditions
Keywords
Adalat, Hypertension, Diabetes, Chronic kidney disease
Brief summary
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.
Interventions
DRUGNifedipine (Adalat CR, BAYA1040)
patients who are administrated with Adalat CR for hypertension
Sponsors
Bayer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient who are administered with Adalat CR for hypertension with diabetes and/or chronic kidney disease (CKD)
Exclusion criteria
* CKD with stage 5 * CDK with dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of participants with Adverse Events for Safety purpose in real practice | After 6 months |
| General evaluation of patient concerning efficacy of AdalatCR treatment in real practice | After 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure, Pulse rate | After 6 months |
| Clinical test values, in specially, microalbumin urea and serum creatinine | After 6 months |
| Overall evaluation | After 6 months |
Countries
Japan
Outcome results
None listed