UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002319
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ichimaru@att.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002833

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.