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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008188
Receipt No. 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

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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
Email

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
Email nomura@med.kyushu-u.ac.jp

Sponsor
Institute Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu 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
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
URL(English) https://upload.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


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