UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000009847
Receipt number	R000011538
Scientific Title	The difference of the effect of ARB on blood pressure and CARDIac functiOn in patients with essential hypertension
Date of disclosure of the study information	2013/01/23
Last modified on	2015/07/23 22:46:47

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Basic information

Public title

The difference of the effect of ARB on blood pressure and CARDIac functiOn in patients with essential hypertension

Acronym

CARDIO Study

Scientific Title

The difference of the effect of ARB on blood pressure and CARDIac functiOn in patients with essential hypertension

Scientific Title:Acronym

CARDIO Study

Region

Japan

Condition

Hypertension

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To compare differnce of the effect of ARB on blood pressure and CARDIac functiOn in patients with essential hypertension

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Blood pressure
Cardiac function

Key secondary outcomes

Endocrine parameters
Vascular function
Renal function

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

olmesartan20mg

Interventions/Control_2

azilsatan20mg

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

Receiving treatment with ARB usual dose(except for olmesartan and azilsartan) for more than six weeks before registration

Key exclusion criteria

1)Hypertensive emergency that requires intravenous administration of antihypertensives
2)Receiving treatment with olmesartan or azilesartan in less than 8 weeks before registration
3)Receiving treatment with Aldosterone antagonists in less than 8 weeks before registration
4)Secondary hypertension
5) Nephritic syndrome
6)Severe renal disease
7)Severe hepatic and biliary tract dysfunction
8) History of cardiovascular events and malignancy within less than 6weeks before registration
9) Pregnancy,the possibility of pregnancy, or the desire to become pregnant.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Takeshi Takami

Organization

Clinic Jingumae

Division name

Internal Medicine

Zip code

Address

5-4-41 Naizencho Kashihara Nara

TEL

0744-23-8568

Email

takami66@m5.kcn.ne.jp

Public contact

Name of contact person

1st name

Middle name

Last name Takeshi Takami

Organization

Clinic Jingumae

Division name

Internal Medicine

Zip code

Address

5-4-41 Naizencho Kashihara Nara

TEL

0744-23-8568

Homepage URL

Email

takami66@m5.kcn.ne.jp

Sponsor or person

Institute

Clinic Jingumae

Institute

Department

Personal name

Funding Source

Organization

Clinic Jingumae

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

Kagawa University Faculty of medicine

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 23 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

Primary end-point
Central blood pressure was improved with both groups, and there is not the difference between groups.
Left ventricular mass, left ventricular dilatation ability was not the change with both groups either, and there is not the difference between groups.
Aldosterone was improved with both groups, there was not the difference between groups.
There was not significant relationship between left ventricular mass, left ventricular dilatation and plasma aldosterone in both groups.

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

2012 Year 08 Month 28 Day

Date of IRB

Anticipated trial start date

2012 Year 11 Month 01 Day

Last follow-up date

2015 Year 03 Month 06 Day

Date of closure to data entry

2015 Year 04 Month 08 Day

Date trial data considered complete

2015 Year 05 Month 18 Day

Date analysis concluded

2015 Year 07 Month 10 Day

Other

Other related information

Secondary end points
SBP, urinary angiotensinogen and urinary albumin were improved with both groups, and there is not the difference between groups.
Subanalisis
There was significant relationship betweent the changes of urinary albumin and the changes of urinary angiotensinogen.

Management information

Registered date

2013 Year 01 Month 23 Day

Last modified on

2015 Year 07 Month 23 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011538

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name