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
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
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
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
