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NCT01363336 Clinical Trial

Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease

Hypertension Clinical Trial

Official title:
Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01363336
Other study ID # 15190
Secondary ID
Status Completed
Phase N/A
First received April 28, 2011
Last updated April 3, 2015
Start date November 2009
Est. completion date July 2013

Study information
Verified date April 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1882
Est. completion date July 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Nifedipine (Adalat CR, BAYA1040)
patients who are administrated with Adalat CR for hypertension

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of participants with Adverse Events for Safety purpose in real practice After 6 months Yes
Primary General evaluation of patient concerning efficacy of AdalatCR treatment in real practice After 6 months Yes
Secondary Blood pressure, Pulse rate After 6 months No
Secondary Clinical test values, in specially, microalbumin urea and serum creatinine After 6 months Yes
Secondary Overall evaluation After 6 months No
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