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

This study is currently recruiting participants.
Verified May 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01363336
First received: April 28, 2011
Last updated: May 19, 2013
Last verified: May 2013
History of Changes
  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:

Drug Information available for: Nifedipine
U.S. FDA Resources

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 ]

Estimated Enrollment: 2000
Study Start Date: November 2009
Estimated Study Completion Date: March 2014
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363336

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Medical Development Japan, Bayer Yakuhin Co.LTD.
ClinicalTrials.gov Identifier: NCT01363336     History of Changes
Other Study ID Numbers: 15190
Study First Received: April 28, 2011
Last Updated: May 19, 2013
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
Kidney Failure, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Nifedipine
Tocolytic Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2013