UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003657 |
|---|---|
| Receipt number | R000004428 |
| Scientific Title | Efficacy of eplerenone added to candesartan on left ventricular hypertrophy and fibrosis in hypertensive patients |
| Date of disclosure of the study information | 2010/05/24 |
| Last modified on | 2018/09/12 16:25:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of eplerenone added to candesartan on left ventricular hypertrophy and fibrosis in hypertensive patients
Acronym
Efficacy of eplerenone added to candesartan in hypertensive patients
Scientific Title
Efficacy of eplerenone added to candesartan on left ventricular hypertrophy and fibrosis in hypertensive patients
Scientific Title:Acronym
Efficacy of eplerenone added to candesartan in hypertensive patients
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
synergistic effect of eplerenone added to candesartan on left ventricular hypertrophy and fibrosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
left ventricular fibrosis
left ventricular diastolic dysfunction
left ventricular hypertrophy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
eplerenone 50mg+candesartan 8mg
Interventions/Control_2
trichlormethiazide 1mg+candesartan 8mg
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
BP 130/85mmHg over in clinic
Key exclusion criteria
over 80 years old
AMI,PCI, stroke, hospitalization of heart failure within 6 months
valvular disease
serum creatinin over 1.5mg/dl in male and over 1.3 in female
proteinuria
liver cirrosis
collagen disease
cancer
chronic inflammatory disease
steroid therapy
diuretics therapy
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahisa Noma |
Organization
Kagawa university hospital
Division name
cardiorenal cerebrovascular medicine
Zip code
Address
1750-1, miki, kita, kagawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
kagawa university hospital
Division name
IRB
Zip code
Address
TEL
Homepage URL
chiken-b@med.kagawa-u.ac.jp
Sponsor or person
Institute
kagawa university hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2010 | Year | 05 | Month | 24 | 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
| 2008 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 24 | Day |
Last modified on
| 2018 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004428
