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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01363336
First received: April 28, 2011
Last updated: April 10, 2014
Last verified: April 2014

April 28, 2011
April 10, 2014
November 2009
June 2013   (final data collection date for primary outcome measure)
  • Evaluation of participants with Adverse Events for Safety purpose in real practice [ Time Frame: After 6 months ] [ Designated as safety issue: Yes ]
  • General evaluation of patient concerning efficacy of AdalatCR treatment in real practice [ Time Frame: After 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01363336 on ClinicalTrials.gov Archive Site
  • Blood pressure, Pulse rate [ Time Frame: After 6 months ] [ Designated as safety issue: No ]
  • Clinical test values, in specially, microalbumin urea and serum creatinine [ Time Frame: After 6 months ] [ Designated as safety issue: Yes ]
  • Overall evaluation [ Time Frame: After 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease
Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The target population of this study is patient who have been administered with Adalat CR for hypertension with diabetes and/or chronic kidney disease. The study is expected to collect data of 2,000 pateints in Japan.

Hypertension
Drug: Nifedipine (Adalat CR, BAYA1040)
patients who are administrated with Adalat CR for hypertension
Group 1
Intervention: Drug: Nifedipine (Adalat CR, BAYA1040)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2043
July 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01363336
15190
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP