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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002479
Receipt No. R000003014
Scientific Title Identifing medical predictors of anti-hypertensive effect of eplerenone
Date of disclosure of the study information 2009/09/11
Last modified on 2017/09/15

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Basic information
Public title Identifing medical predictors of anti-hypertensive effect of eplerenone
Acronym IMPRESSIVE Study
Scientific Title Identifing medical predictors of anti-hypertensive effect of eplerenone
Scientific Title:Acronym IMPRESSIVE Study
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify predictors of anti-hypertensive effect of eplerenone, which is a selective mineralocorticoid receptor antagonist, among clinical parameters.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between aldosterone/renin ratio before administration of eplerenone and anti-hypetensive effect.
Key secondary outcomes Correlation between other parameters, which include BMI, waist circumference, gender, urinary Na excretion, urinary aldosterone, urinary free cortisol, renal 11beta-hydroxysteroid dehydrogenase activity, serum K, creatinine, ANP, BNP, and urinary 8OHdG, and anti-hypetensive effect.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administer 50mg of eplerenone for one month and check blood pressure. For another month upscale 50mg to 100mg of eplerenone and re-check anti-hypertensive effect.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient with high blood pressure (systolic BP>140mmHg and/or diastolic BP>90mHg)
Key exclusion criteria 1. renal dysfunction (eGFR<50ml/min or male Cr>2.0mg/dl, female Cr>1.8mg/dl)
2. liver dysfunction
3. serum K>5.0mEq/l before intervention
4. diabetes
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotaka Shibata
Organization School of Medicine, Keio University
Division name Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirotaka Shibata
Organization School of Medicine, Keio University
Division name Internal Medicine
Zip code
Address
TEL
Homepage URL
Email hiro-405@cb3.so-net.ne.jp

Sponsor
Institute Department of Internal Medicine, School of Medicine, Keio University
Institute
Department

Funding Source
Organization Pfizer Japan Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 09 Month 11 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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2017 Year 06 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 09 Month 10 Day
Last modified on
2017 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003014

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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