HypertensionNCT01363336
Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease
An observational study of Hypertension, run by Bayer at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- Nifedipine (Adalat CR, BAYA1040)
- How many people
- 1,882 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2009to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patient who are administered with Adalat CR for hypertension with diabetes and/or chronic kidney disease (CKD)
Who cannot join
- CKD with stage 5
- CDK with dialysis
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Nifedipine (Adalat CR, BAYA1040)
- Keywords
- Adalat, Hypertension, Diabetes, Chronic kidney disease
- Medical subject headings
- Hypertension, Diabetes Mellitus, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine (Adalat CR, BAYA1040)Drug
patients who are administrated with Adalat CR for hypertension
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Nifedipine (Adalat CR, BAYA1040) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of participants with Adverse Events for Safety purpose in real practice
Measured: After 6 months
General evaluation of patient concerning efficacy of AdalatCR treatment in real practice
Measured: After 6 months
Secondary outcomes (3)
Blood pressure, Pulse rate
Measured: After 6 months
Clinical test values, in specially, microalbumin urea and serum creatinine
Measured: After 6 months
Overall evaluation
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startNov 2009
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,882 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363336
- Sponsor's protocol ID
- 15190
- Status last verified
- Apr 2015
- First submitted
- 28 Apr 2011
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01363336
- Acronym / sponsor ID
- 15190
- Conditions
- Hypertension
- Keywords
- Adalat, Hypertension, Diabetes, Chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,882 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Nifedipine (Adalat CR, BAYA1040) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patient who are administered with Adalat CR for hypertension with diabetes and/or chronic kidney disease (CKD)
Key exclusion criteria (2 listed)
- CKD with stage 5
- CDK with dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nifedipine (Adalat CR, BAYA1040)patients who are administrated with Adalat CR for hypertension | Drug | Group 1 |
Primary outcome
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
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Bayer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of participants with Adverse Events for Safety purpose in real practice (time frame: After 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2015; AzTrials last refreshed its copy on 26 Oct 2026.