UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001199 |
|---|---|
| Receipt number | R000001407 |
| Scientific Title | The assessment of the endothelial function using aldosterone receptor blockade in patients with hypertension |
| Date of disclosure of the study information | 2009/01/01 |
| Last modified on | 2008/06/19 13:02:32 |
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Basic information
Public title
The assessment of the endothelial function using aldosterone receptor blockade in patients with hypertension
Acronym
EPLENDO
Scientific Title
The assessment of the endothelial function using aldosterone receptor blockade in patients with hypertension
Scientific Title:Acronym
EPLENDO
Region
| Japan |
Condition
Condition
essential hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of the endothelial function using aldosterone receptor blockade in patients with hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
blood pressure, heart rate, FMD, EPC
Key secondary outcomes
none
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eplerenone
Interventions/Control_2
Ca blockers
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
essential hypertension
Key exclusion criteria
secondary hypertension
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihito Higashi |
Organization
Hiroshima University
Division name
Department of Cardiovascular Physiology and Medicine
Zip code
Address
1-2-3 kasumi minami-ku hiroshima-shi
TEL
0822575555
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaki Hata |
Organization
Hiroshima University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-2-3 kasumi minami-ku hiroshima-shi
TEL
0822575555
Homepage URL
http://home.hiroshima-u.ac.jp/seiri1
superhatachan@gmail.com
Sponsor or person
Institute
Hiroshima Endothelial Function Study Group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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 | 01 | Month | 01 | Day |
Related information
URL releasing protocol
http://home.hiroshima-u.ac.jp/seiri1/
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
Date of protocol fixation
| 2008 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 19 | Day |
Last modified on
| 2008 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001407
