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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Chronic Disease Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nifedipine (Adalat CR, BAYA1040)

Drug

patients who are administrated with Adalat CR for hypertension

Primary outcomes

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

Time frame: After 6 months
General evaluation of patient concerning efficacy of AdalatCR treatment in real practice

Time frame: After 6 months

Secondary outcomes

Blood pressure, Pulse rate

Time frame: After 6 months
Clinical test values, in specially, microalbumin urea and serum creatinine

Time frame: After 6 months
Overall evaluation

Time frame: After 6 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Jun 1, 2011
Registry last updated: Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed