UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012587
Receipt number R000009744
Scientific Title Switch from ARB Combination Tablets to Azilsartan: Clinical research on organ protective effect in hypertensive patients living in Okayama
Date of disclosure of the study information 2013/12/16
Last modified on 2014/06/18 21:00:32

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Basic information

Public title

Switch from ARB Combination Tablets to Azilsartan: Clinical research on organ protective effect in hypertensive patients living in Okayama

Acronym

MAGENTA study

Scientific Title

Switch from ARB Combination Tablets to Azilsartan: Clinical research on organ protective effect in hypertensive patients living in Okayama

Scientific Title:Acronym

MAGENTA study

Region

Japan


Condition

Condition

Essential hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of azilsartan 40mg on blood pressrue lowering after swiching from combination tablet including ARB

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in blood pressure

Key secondary outcomes



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

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

30 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

Patients recieving combination tablet including ARB, and sysytolic blood pressure < 160 mmHg and daistolic pressure < 100 mmHg

Key exclusion criteria

1, Secondary hypertension
2, Severe hypertension(SBP 200mmHg or more or DBP 115mmHg or more)
3, Congestive heart failure
4, Severe valvular disease
5, Myocardial infarction or acute period of cerebrovascular disease(within 6 months)
6, Atrial fibrillation(paroxysmal,stained,chronic)
7, Malignant ventricular arrhythmia
8, Renal insufficiency(Serum creatinine 2mg/dL or more)
9, Severe Liver Dysfunction
10, Chronic inflammatory disease
11, The patient with a malignant tumor
12, Patients who are determined by the investigators to be unsuitable

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toru Miyoshi

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesDepartment of Cardiovascular Medicine

Division name

Department of Cardiovascular Medicine

Zip code


Address

2-5-1 Shikada-cho Kita-ku Okayama

TEL

086-235-7351

Email

miyoshit@cc.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toru Miyoshi

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesDepartment of C

Division name

Department of Cardiovascular Medicine

Zip code


Address

2-5-1 Shikada-cho Kita-ku Okayama

TEL

086-235-7351

Homepage URL


Email

miyoshit@cc.okayama-u.ac.jp


Sponsor or person

Institute

Department of Cardiovascular, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesDepartment of Cardiovascular Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiovascular, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesDepartment of Cardiovascular Medicine

Organization

Division

Category of Funding Organization

Other

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 12 Month 16 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2012 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 10 Day

Last follow-up date

2013 Year 12 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 12 Month 16 Day

Last modified on

2014 Year 06 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009744


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name