UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008005
Receipt number 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 15:42:31

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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