UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010610
Receipt number R000012405
Scientific Title Medical effects of Azilsartan in patients with hypertension not controlled by other ARBs
Date of disclosure of the study information 2013/05/01
Last modified on 2020/12/23 21:45:03

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Basic information

Public title

Medical effects of Azilsartan in patients with hypertension not controlled by other ARBs

Acronym

MAZIC study

Scientific Title

Medical effects of Azilsartan in patients with hypertension not controlled by other ARBs

Scientific Title:Acronym

MAZIC study

Region

Japan


Condition

Condition

hypertension

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of Azilsartan in patients with hypertension not achieve the target blood pressure of JSH2009 by other ARBs

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase IV


Assessment

Primary outcomes

hospital blood pressure

Key secondary outcomes

home BP(early morning, evening),ABPM,
urine albumin, BNP, hs-CRP, urinary sodium excretion, Serum K, eGFR, HbA1c


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Azilsartan

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients not achieve the target blood pressure of JSH2009 with other ARBs

Key exclusion criteria

1) A history of allergy/hypersensitivity

2) Pregnant women

12) Not eligible for this study based on the decision's of a physician

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masato Watarai

Organization

Anjo Kosei Hospital

Division name

department of cardiology

Zip code


Address

28,Higashihirokute,Anjo-cho,Anjo-shi,Aichi-ken

TEL

0566-75-2111

Email

watarai@kosei.anjo.aichi.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenshi Hirayama

Organization

Anjo Kosei Hospital

Division name

department of cardiology

Zip code


Address

28,Higashihirokute,Anjo-cho,Anjo-shi,Aichi-ken

TEL

0566-75-2111

Homepage URL


Email

kenshi28sep@gmail.com


Sponsor or person

Institute

Nishi Mikawa Cardiologist Conference

Institute

Department

Personal name



Funding Source

Organization

self funding

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

2013 Year 05 Month 01 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

Terminated

Date of protocol fixation

2013 Year 04 Month 22 Day

Date of IRB

2016 Year 03 Month 31 Day

Anticipated trial start date

2013 Year 05 Month 01 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 04 Month 29 Day

Last modified on

2020 Year 12 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012405


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name