UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009469
Receipt number R000011122
Scientific Title Effect of ARB on Blood Pressure and Quality of Life
Date of disclosure of the study information 2012/12/03
Last modified on 2015/06/03 13:59:19

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Basic information

Public title

Effect of ARB on Blood Pressure and Quality of Life

Acronym

APEQ

Scientific Title

Effect of ARB on Blood Pressure and Quality of Life

Scientific Title:Acronym

APEQ

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

For a hypertensive patient, examine the validity and QOL of azilsultan medical treatment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

he amount of change of the ambulatory blood pressure at baseline and after 3 months of use

Key secondary outcomes

1) The Quantity of change of the QOL score at baseline and after 3 months of use.
2) The amount of change of a blood test value at baseline and after 3 months of use.
3) The amount of change of home blood pressure at baseline and after 3 months of use.
4) Safety which led overall treatment term/time.


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

Medical treatment which drops blood pressure is aimed at by azilsultan.

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

The patient who treated by combined use of ARB (except azilsultan) or other antihypertensive agents one month or more, and the hypertensive patient of high-blood-pressure guideline target unattainment

Key exclusion criteria

1) Secondary hypertensive patient
2) Patients with moderate or severe cardiac dysfunction (NYHA class 3 or 4)
3) Pregnant and/or expecting women
4) Patients with severe impaired liver function
5)Patients with kidney dysfunction(sCr>=2.0mg/dl)
6) Patients with a history of hypersensitivity to the azilsultan
7)Patients who are considered not eligible for the study by the attending doctor due to other reasons

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichi Node

Organization

Saga University Faculty of Medicine

Division name

Department of Cardiovascular medicine

Zip code


Address

5-1-1 Nabeshima, Saga-shi, Saga

TEL

0952-34-2364

Email

node@cc.saga-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junichi Oyama

Organization

Study group for Hypertension medical treatment in Saga

Division name

Secretariat

Zip code


Address

5-1-1Nabeshima, Saga-shi, Saga

TEL

0952-34-2364

Homepage URL


Email

junoyama@cc.saga-u.ac.jp


Sponsor or person

Institute

Study group for Hypertension medical treatment in Saga

Institute

Department

Personal name



Funding Source

Organization

The Kidney Foundation, Japan

Organization

Division

Category of Funding Organization

Non profit foundation

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

佐賀大学医学部附属病院、池田内科皮膚科医院、ロコメディカル江口病院、伊万里有田共立病院、佐賀県医療センター好生館、唐津赤十字病院、佐賀記念病院、福田脳神経外科病院、志田病院、鶴田内科循環器科医院、矢ヶ部医院、山口クリニック、えとう内科循環器内科、諸江内科循環器科医院、ニコークリニック、貝原医院、大町町立病院、織田病院、朝長医院、河畔病院、脇山内科、岩本内科、関医院、城内病院、水上医院、石井内科、中尾胃腸科医院、南医院、うえむら病院、枝國医院、高橋内科、藤崎医院、鶴田内科(以上、すべて佐賀県)、三佼会宮崎病院(長崎)


Other administrative information

Date of disclosure of the study information

2012 Year 12 Month 03 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

azilsultan medical treatment group, the blood pressure tends to fall.

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 11 Month 12 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 10 Day

Last follow-up date

2014 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective observational study


Management information

Registered date

2012 Year 12 Month 03 Day

Last modified on

2015 Year 06 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011122


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name