UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013065 |
|---|---|
| Receipt number | R000015236 |
| Scientific Title | The influence of irbesartan on biomarkers of renal function and oxidative stress |
| Date of disclosure of the study information | 2014/02/05 |
| Last modified on | 2016/01/07 11:50:24 |
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Basic information
Public title
The influence of irbesartan on biomarkers of renal function and oxidative stress
Acronym
The influence of irbesartan on renal function
Scientific Title
The influence of irbesartan on biomarkers of renal function and oxidative stress
Scientific Title:Acronym
The influence of irbesartan on renal function
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the protective effect of irbesartan from renal dysfunction, inflammation, and oxidative stress
Basic objectives2
Others
Basic objectives -Others
To investigate the changes of renal biomarker of liver-type fatty acid binding protein (L-FABP) after administration of irbesartan
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The changes of renal biomarker of liver-type fatty acid binding protein (L-FABP)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Irbesartan
Interventions/Control_2
Amlodipine
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
The patients of hypertension who need medication
Key exclusion criteria
(a) patietns exceeding or under the age limit
(b) patietns in whom the side effect of irbesartan possibly occure
(c) patietns with past heart failure
(d) patietns with ejection fraction under 40%
(e) patietns with other reasons not appropriate for the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Masaki |
Organization
National Defense Medical College
Division name
Department of cardiology
Zip code
Address
3-2Namiki,Tokorozawa
TEL
0429-95-1211
nmasaki@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Masaki |
Organization
National Defense Medical College
Division name
Department of cardiology
Zip code
Address
3-2Namiki,Tokorozawa
TEL
0429-95-1211
Homepage URL
nmasaki@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 02 | Month | 05 | 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
We could not see specific association betwee urine F-ABP and the administration of irbesartan in the first 10 patients. Then we stopped the trial.
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
Terminated
Date of protocol fixation
| 2014 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 04 | Day |
Last modified on
| 2016 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015236
