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

NCT01363336 | Completed

• 1 other identifier: 15190
• Study Type: observational
• Target: 1,882
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Adalat; Hypertension; Diabetes; Chronic kidney disease

Outcome Measures

Primary Outcomes (2)

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

  After 6 months

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

  After 6 months

Secondary Outcomes (3)

• Blood pressure, Pulse rate

  After 6 months

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

  After 6 months

• Overall evaluation

  After 6 months

Study Arms (1)

Group 1

Drug: Nifedipine (Adalat CR, BAYA1040)

Interventions

Nifedipine (Adalat CR, BAYA1040) DRUG

patients who are administrated with Adalat CR for hypertension

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient who are administered with Adalat CR for hypertension with diabetes and/or chronic kidney disease (CKD)

You may not qualify if:

• CKD with stage 5
• CDK with dialysis

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Japan

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Renal Insufficiency, Chronic

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: June 1, 2011
• Study Start: November 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 6, 2015

Record last verified: 2015-04

Locations

JP (1)