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

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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


Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name