UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002479 |
|---|---|
| Receipt number | 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 13:30:32 |
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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
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
hiro-405@cb3.so-net.ne.jp
Sponsor or person
Institute
Department of Internal Medicine, School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003014
| Research Plan | |
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| 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 |
