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

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ClinicalTrials.gov Identifier: NCT01363336
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : April 6, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hypertension Drug: Nifedipine (Adalat CR, BAYA1040)

Study Design

Study Type : Observational
Actual Enrollment : 1882 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease
Study Start Date : November 2009
Primary Completion Date : June 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Nifedipine
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Evaluation of participants with Adverse Events for Safety purpose in real practice [ Time Frame: After 6 months ]
  2. General evaluation of patient concerning efficacy of AdalatCR treatment in real practice [ Time Frame: After 6 months ]

Secondary Outcome Measures :
  1. Blood pressure, Pulse rate [ Time Frame: After 6 months ]
  2. Clinical test values, in specially, microalbumin urea and serum creatinine [ Time Frame: After 6 months ]
  3. Overall evaluation [ Time Frame: After 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363336


Locations
Japan
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01363336     History of Changes
Other Study ID Numbers: 15190
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: April 6, 2015
Last Verified: April 2015

Keywords provided by Bayer:
Adalat
Hypertension
Diabetes
Chronic kidney disease

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs