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
  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.


Condition Intervention
Hypertension
Drug: Nifedipine (Adalat CR, BAYA1040)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2043
Study Start Date: November 2009
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Nifedipine (Adalat CR, BAYA1040)
patients who are administrated with Adalat CR for hypertension

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363336

Locations
Japan
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01363336     History of Changes
Other Study ID Numbers: 15190
Study First Received: April 28, 2011
Last Updated: April 10, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Adalat
Hypertension
Diabetes
Chronic kidney disease

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Cardiovascular Diseases
Renal Insufficiency
Urologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014