UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017785
Receipt number R000020601
Scientific Title A study of irbesartan/amlodipine on hypertensive patients
Date of disclosure of the study information 2015/06/03
Last modified on 2015/09/07 20:09:39

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Basic information

Public title

A study of irbesartan/amlodipine on hypertensive patients

Acronym

AIMIX study

Scientific Title

A study of irbesartan/amlodipine on hypertensive patients

Scientific Title:Acronym

AIMIX study

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To study the antihypertensive and renal protective effects of irbesartan/amlodipine.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood pressure change

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

Irbesartan/Amloipine

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

Hypertensive patients

Key exclusion criteria

1) Allergy to Irbesartan/Amloipine
2) Renal aretery stenosis of one or both sides
3) Severe liver dysfunction
4) Alcoholic or drug abuse
5) Pregnancy or nursing
6) Myocardial and cerebral infarction in three months
7) Blood tests are as follows.
a) AST or ALT more than 2.5 folds or equal to standard values
b) Total bilirubin more than or equal to 3.0 mg/dL
c) Serum creatinine more than or equal to 2.5 mg/dL
d) Serum potassium more than or equal to 5.0 mEq/L
8) Other inappropiate patients

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisao Ogawa

Organization

Kumamoto University

Division name

Department of Cardiology

Zip code


Address

1-1-1 Honjo, Chuo-ku, Kumamoto-city

TEL

096-373-5175

Email

ogawah@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Osamu Yasuda

Organization

Kumamoto University

Division name

Department of Cardiology

Zip code


Address

1-1-1 Honjo, Chuo-ku, Kumamoto-city

TEL

096-373-5393

Homepage URL


Email

o-yasuda@kumamoto-u.ac.jp


Sponsor or person

Institute

Kumamoto University

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

2015 Year 06 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


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 10 Month 16 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 06 Month 03 Day

Last modified on

2015 Year 09 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020601


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name