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

Bayer

Status: Completed

Conditions: Hypertension

Treatments: Drug: Nifedipine (Adalat CR, BAYA1040)

Study type: Observational

Funder types: Industry

Identifiers

NCT01363336

15190

Details and patient eligibility

About

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.

Enrollment: 1,882 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,882 participants in 1 patient group

Group 1

Treatment:

Drug: Nifedipine (Adalat CR, BAYA1040)