Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease
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ClinicalTrials.gov Identifier: NCT01363336 |
Recruitment Status
:
Completed
First Posted
: June 1, 2011
Last Update Posted
: April 6, 2015
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
Tracking Information | ||||
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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 |
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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 |
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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 |
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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 |
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Study Groups/Cohorts | Group 1
Intervention: Drug: Nifedipine (Adalat CR, BAYA1040) |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
1882 | |||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
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 |
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PRS Account | Bayer | |||
Verification Date | April 2015 |