UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002319 |
|---|---|
| Receipt number | R000002833 |
| Scientific Title | Design and operation of algorithm about blood pressure control treatment using benidipine hydrochloride for hypertensive patients after renal transplantation. |
| Date of disclosure of the study information | 2009/08/10 |
| Last modified on | 2019/03/05 13:37:24 |
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Basic information
Public title
Design and operation of algorithm about blood pressure control treatment using benidipine hydrochloride for hypertensive patients after renal transplantation.
Acronym
Design of blood pressure control algorithm for hypertensive patients after renal transplantation.
Scientific Title
Design and operation of algorithm about blood pressure control treatment using benidipine hydrochloride for hypertensive patients after renal transplantation.
Scientific Title:Acronym
Design of blood pressure control algorithm for hypertensive patients after renal transplantation.
Region
| Japan |
Condition
Condition
Hypertension after renal transplantation
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To design of algorithm about blood pressure control treatment using anti-hypertensive drugs for hypertensive patients after renal transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time course of blood pressure and achievement of target blood pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Blood pressure control treatment using anti-hypertensive drugs for hypertensive patients within one month after renal transplantation was designed and tried to operate this algorithm by frequent blood pressure measurement.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Systolic blood pressure ; more than 140 mmHg
Key exclusion criteria
1) Patients with cardiogenic shock
2) Pregnant or possibly pregnant women
3) Patients with other serious illness or significant abnormalities that the doctor judges inappropriate for the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naotsugu Ichimaru |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Specific Organ Regulation (Urology)
Zip code
Address
Yamadaoka, 2-2, E4, Suita city, Osaka
TEL
06-679-3531
ichimaru@att.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naotsugu Ichimaru |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Specific Organ Regulation (Urology)
Zip code
Address
Yamadaoka, 2-2, E4, Suita city, Osaka
TEL
06-6879-3531
Homepage URL
ichimaru@att.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 10 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002833
