UMIN-CTR Clinical Trial

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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