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

April 3, 2015 updated by: Bayer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1882

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Many Locations, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Nifedipine (Adalat CR, BAYA1040)
patients who are administrated with Adalat CR for hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of participants with Adverse Events for Safety purpose in real practice
Time Frame: After 6 months
After 6 months
General evaluation of patient concerning efficacy of AdalatCR treatment in real practice
Time Frame: After 6 months
After 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure, Pulse rate
Time Frame: After 6 months
After 6 months
Clinical test values, in specially, microalbumin urea and serum creatinine
Time Frame: After 6 months
After 6 months
Overall evaluation
Time Frame: After 6 months
After 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

May 30, 2011

First Posted (Estimate)

June 1, 2011

Study Record Updates

Last Update Posted (Estimate)

April 6, 2015

Last Update Submitted That Met QC Criteria

April 3, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15190

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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