UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008188 |
|---|---|
| Receipt number | R000009428 |
| Scientific Title | Kyushu Irbesartan intervention trial for improvement of hypertension, glucose and lipid metabolism in hypertensive patients |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2012/06/17 12:55:08 |
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Basic information
Public title
Kyushu Irbesartan intervention trial for improvement of hypertension, glucose and lipid metabolism in hypertensive patients
Acronym
Effects on metabolism by irbesartan trial in essential hypertensive patients (MEISTRE)
Scientific Title
Kyushu Irbesartan intervention trial for improvement of hypertension, glucose and lipid metabolism in hypertensive patients
Scientific Title:Acronym
Effects on metabolism by irbesartan trial in essential hypertensive patients (MEISTRE)
Region
| Japan |
Condition
Condition
Essential hypertension
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to analyze the effects of irbesartan on glucose and lipid metabolism in hypertensive patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of glucose and lipid profiles by the treatment of irbesartan
Key secondary outcomes
To evaluate the Improvement of pancreas b cell function by the treatment of irbesartan, the ratio of insulin and proinsulin will be analyzed.
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 | Behavior,custom |
Interventions/Control_1
Prescribe irbetan (100mg) to essential hypertensive patients. If the blood pressure does not become within normal limits, another 100mg of irbetan or other hypertension medicine involved in RA pathway will be added.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The hypertensive patient who meet the following criteria.
1) untreated patient
2) The patients who have 140/90 mmHg or more. In the case of diabetes, 130/80 or more.
3) The patients whose agreement to exam participation is obtained in the document
Key exclusion criteria
The patients who meet the following criteria will be excluded.
A. The patient who has been prescribed the medicine involved in RA pathway for 8 weeks or more.
b.HbA1c 10.0% or more.
C. LDL-cholesterole 180 mg/dL or more.
D. BMI35 or more
E. The patient who corresponds to the taboo or prudent usage of irubetan.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoichi Takayanagi |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Bioregulatory Science,
Zip code
Address
Maidashi3-1-1, Higashi-ku, Fukuoka, Japan
TEL
092-642-5275
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatoshi Nomura |
Organization
Kyushu University Hospital
Division name
Division of Endocrinology and Metabolism
Zip code
Address
Maidashi3-1-1, Higashi-ku, Fukuoka, Japan
TEL
092-642-5293
Homepage URL
nomura@med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu 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
| 2012 | Year | 07 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 17 | Day |
Last modified on
| 2012 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009428
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
