UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000588 |
|---|---|
| Receipt number | R000000714 |
| Scientific Title | The prevention effect of ARB(Candesartan) upon chronic heart failure of the newly hemo-dialysis patients |
| Date of disclosure of the study information | 2010/03/30 |
| Last modified on | 2007/01/30 23:29:32 |
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Basic information
Public title
The prevention effect of ARB(Candesartan) upon chronic heart failure of the newly hemo-dialysis patients
Acronym
The effect of ARB upon newly HD patients
Scientific Title
The prevention effect of ARB(Candesartan) upon chronic heart failure of the newly hemo-dialysis patients
Scientific Title:Acronym
The effect of ARB upon newly HD patients
Region
| Japan |
Condition
Condition
Heart failure and cardiovascular disease in the newly hemo-dialysis patients
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The prevention effect of ARB(Candesartan) upon chronic heart failure of the newly hemo-dialysis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total death, cardiovascular event, cerebrovascular event, total hospitalization
Key secondary outcomes
cardiac hemodynamics, heart function, cardiac conformation measured by each half yearly echocardiography,
serum, ANP, BNP, adiponection, lipid in each half year
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ARB(Candesartan) treatment with standard hypertensive therapy
Interventions/Control_2
standard antihypertensive therapy without any ACE-I,ARB, anti-aldosterone
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
newly hemodialysis patients whose informed consent were obtained
Key exclusion criteria
Patients with cardiovascular and/or cerebrovascular event
Patients with severe liver failure and/or lung dysfunction
Patients with malignancy which were diagnosed within 3 years
Patients who were not suitable for this trial, judged by the attending doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Enyu Imai |
Organization
Osaka University, Graduate School of Medicine
Division name
Nephrology
Zip code
Address
Osaka-fu,Suita-shi,Yamadaoka2-2
TEL
06-6879-3632
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Nagasawa |
Organization
Osaka University, Graduate School of Medicine
Division name
Nephrology
Zip code
Address
Osaka-fu,Suita-shi,Yamadaoka2-2
TEL
06-6879-3632
Homepage URL
nagasawa@medone.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University, Graduate School of Medicine, Devision of Nephrology
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka General Medical Center
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
| 2010 | Year | 03 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2006 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 01 | Month | 30 | Day |
Last modified on
| 2007 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000714
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
