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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008005
Receipt No. R000009415
Scientific Title Japanese Telmisartan versus Irbesartan Therapy to Fasting Hyperglycemic Patients with Hypertension
Date of disclosure of the study information 2012/05/21
Last modified on 2012/05/28

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Basic information
Public title Japanese Telmisartan versus Irbesartan Therapy to Fasting Hyperglycemic Patients with Hypertension
Acronym J-TIGHT
Scientific Title Japanese Telmisartan versus Irbesartan Therapy to Fasting Hyperglycemic Patients with Hypertension
Scientific Title:Acronym J-TIGHT
Region
Japan

Condition
Condition Fasting hyperglycemic patients with hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 It is known that Peroxisome proliferator-activated receptor-gamma (PPARgamma) could improve insulin resistance. Both telmisartan and irbesartan were angiotensin receptor blockers which have PPARgamma activating action. In this study, we compare the effects of telmisartan and irbesartan to hypertensive patients with fasting hyperglycemia that is one of the causes of the insulin resistance.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The variation of fasting blood glucose level 24 weeks after medical treatment
Key secondary outcomes 1) The variation of blood pressure 24 weeks after medical treatment
2) The variation of fasting insulin, HOMA-IR, HbA1c, adiponectin and high sensitive CRP levels 24 weeks after medical treatment
3) The variation of total cholesterol, low density lipoprotein, high density lipoprotein and triglyceride levels 24 weeks after medical treatment
4) The rate of onset of new diabetes 24 weeks after medical treatment
5) The achievement rate of targeted blood pressure 24 weeks after medical treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 telmisartan
40-80 mg/day for 24 weeks
Interventions/Control_2 irbesartan
100-200 mg/day for 24 weeks
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
30 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) The patients with more than systolic blood pressure 140 mmHg or diastolic blood pressure 90 mmHg with untreatment or treatment with antihypertensive medications except the inhibitors of renin-angiotensin system (ARB, ACEI, an renin inhibitor, an aldosterone receptor blocker).
2) The fasting blood glucose level is 110 mg/dL and more, and less than 126 mg/dL
Key exclusion criteria 1) The patients with secondary hypertension
2) The patients with diagnosed diabetes which are treated with medication
3) The patients received a dialysis treatment
4) The patients with a history of hypersensitivity for test drugs
5) The women who are or may be pregnant
6) The patients with extremely poor bile secretion (total bilirubin more than 2.0 mg/dL) or severe hepatopathy (AST or ALT more than 100I U/L)
7) The patients judged inappropriate by the physicians
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minoru Yoshiyama
Organization Osaka City University Medical School
Division name Department of Internal Medicine and Cardiology
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan
TEL 06-6645-3801
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasukatsu Izumi
Organization Osaka City University Medical School
Division name Department of Pharmacology
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan
TEL 06-6645-3731
Homepage URL
Email

Sponsor
Institute Department of Internal Medicine and Cardiology, Osaka City University Medical School
Institute
Department

Funding Source
Organization self-sustaining fund
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 05 Month 21 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
2011 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2014 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 21 Day
Last modified on
2012 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009415

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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