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

Tracking Information
First Submitted Date	April 28, 2011
First Posted Date	June 1, 2011
Last Update Posted Date	April 6, 2015
Study Start Date	November 2009
Actual Primary Completion Date	June 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: May 30, 2011)	Evaluation of participants with Adverse Events for Safety purpose in real practice [ Time Frame: After 6 months ]; General evaluation of patient concerning efficacy of AdalatCR treatment in real practice [ Time Frame: After 6 months ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01363336 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: May 30, 2011)	Blood pressure, Pulse rate [ Time Frame: After 6 months ]; Clinical test values, in specially, microalbumin urea and serum creatinine [ Time Frame: After 6 months ]; Overall evaluation [ Time Frame: After 6 months ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease
Official Title	Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or 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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	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.
Condition	Hypertension
Intervention	Drug: Nifedipine (Adalat CR, BAYA1040); patients who are administrated with Adalat CR for hypertension
Study Groups/Cohorts	Group 1; Intervention: Drug: Nifedipine (Adalat CR, BAYA1040)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: April 3, 2015)	1882
Original Estimated Enrollment; (submitted: May 30, 2011)	2000
Actual Study Completion Date	July 2013
Actual Primary Completion Date	June 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria	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
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Japan
Removed Location Countries
Administrative Information
NCT Number	NCT01363336
Other Study ID Numbers	15190
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Bayer
Study Sponsor	Bayer
Collaborators	Not Provided
Investigators	Study Director: Bayer Study Director Bayer
PRS Account	Bayer
Verification Date	April 2015