DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

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

Phase: N/A

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

Evaluation of participants with Adverse Events for Safety purpose in real practice

General evaluation of patient concerning efficacy of AdalatCR treatment in real practice

Secondary outcome:

Blood pressure, Pulse rate

Clinical test values, in specially, microalbumin urea and serum creatinine

Overall evaluation

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Many Locations, Japan
Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here and search for websynopsis results

Starting date: November 2009
Last updated: April 3, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017