Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease
- Registration Number
- NCT01363336
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1882
Inclusion Criteria
- Patient who are administered with Adalat CR for hypertension with diabetes and/or chronic kidney disease (CKD)
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Exclusion Criteria
- CKD with stage 5
- CDK with dialysis
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Nifedipine (Adalat CR, BAYA1040) -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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