Trial Condition(s):
Hypertension
Post-marketing Surveillance for hypertensive patients with diabetes and/or chronic kidney disease
Bayer Identifier:
15190
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Post-marketing Surveillance for hypertensive patients with diabetes and/or chronic kidney disease
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Evaluation of participants with Adverse Events for Safety purpose in real practiceTimeframe: After 6 months
- General evaluation of patient concerning efficacy of AdalatCR treatment in real practiceTimeframe: After 6 months
Secondary Outcome
- Blood pressure, Pulse rateTimeframe: After 6 months
- Clinical test values, in specially, microalbumin urea and serum creatinineTimeframe: After 6 months
- Overall evaluationTimeframe: After 6 months
Additional Information
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