check_circleStudy Completed

Hypertension

Bayer Identifier:

15190

ClinicalTrials.gov Identifier:

NCT01363336

EudraCT Number:

Not Available

EU CT Number:

Not Available
Post-marketing Surveillance for hypertensive patients with diabetes and/or chronic kidney disease

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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Patient who are administered with Adalat CR for hypertension with diabetes and/or chronic kidney disease (CKD)

  • - CKD with stage 5
    - CDK with dialysis

Trial summary

Enrollment Goal
1882
Trial Dates
November 2009 - July 2013
Phase
N/A
Could I Receive a placebo
No
Products
Adalat CC (Nifedipine, BAYA1040)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Evaluation of participants with Adverse Events for Safety purpose in real practice
    date_rangeTime Frame:
    After 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • General evaluation of patient concerning efficacy of AdalatCR treatment in real practice
    date_rangeTime Frame:
    After 6 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Blood pressure, Pulse rate
    date_rangeTime Frame:
    After 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Clinical test values, in specially, microalbumin urea and serum creatinine
    date_rangeTime Frame:
    After 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Overall evaluation
    date_rangeTime Frame:
    After 6 months
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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