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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001199
Receipt No. 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

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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
Email

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
Email superhatachan@gmail.com

Sponsor
Institute Hiroshima Endothelial Function Study Group
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001407

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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