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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017785
Receipt No. 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

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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
Institute Kumamoto University
Institute
Department

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
URL(English) https://upload.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


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