UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000469
Receipt number R000000570
Scientific Title Study on pleiotropic effects of angiotensin II- receptor blockers (ARB) in hypertensive obese patients.
Date of disclosure of the study information 2006/09/01
Last modified on 2011/09/06 08:58:21

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Basic information

Public title

Study on pleiotropic effects of angiotensin II- receptor blockers (ARB) in hypertensive obese patients.

Acronym

Effects of ARBs in hypertensive obese patients.

Scientific Title

Study on pleiotropic effects of angiotensin II- receptor blockers (ARB) in hypertensive obese patients.

Scientific Title:Acronym

Effects of ARBs in hypertensive obese patients.

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Validate the usefulness of ARB in obese patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in fasting plasma glucose and insulin levels
Change in serum lipid profile
Change in high-sensitive CRP

Key secondary outcomes

Change in serum adiponectin level
Change in serum AGE-2


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

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Normal dosage of telmisartan is administered for 6 months after randomization

Interventions/Control_2

Normal dosage of valsartan is administered for 6 months after randomization

Interventions/Control_3

Normal dosage of candesartan is administered for 6 months after randomization

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Patients with obesity whose BMI exceeding 25
2. Patients with hypertension (Systolic blood pressure is >=140 or diastolic >=90)

Key exclusion criteria

-patients with secondary hypertension
-patients whose AST or ALT exceeding 100IU/L
-patients with bile stenosis
-patients with severe renal failure or nephrotic syndrome
-patients with severe cerebral infarction
-pregnant women or those who plan pregnancy, or in the lactation period
-patients with neoplasm
-patients with history of hypersensitivity to telmisartan, valsartan, or candesartan
-other patients judged unsuitable for the study by the investigator

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masamitsu Nakazato

Organization

Department of Internal Medicine, University of Miyazaki Faculty of Medicine

Division name

Neurology, Respirology, Endocrinology and Metabolism

Zip code


Address

5200 Kihara, Kiyotake, Miyazaki 889-1692

TEL

0985-85-2965

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masanari Mizuta

Organization

Department of Internal Medicine, University of Miyazaki Faculty of Medicine

Division name

Neurology, Respirology, Endocrinology and Metabolism

Zip code


Address

5200 Kihara, Kiyotake, Miyazaki 889-1692

TEL

0985-85-2965

Homepage URL


Email

mmizuta@fc.miyazaki-u.ac.jp


Sponsor or person

Institute

3M STUDY GROUP

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


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

2006 Year 09 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

No longer recruiting

Date of protocol fixation

2004 Year 11 Month 18 Day

Date of IRB


Anticipated trial start date

2004 Year 12 Month 01 Day

Last follow-up date

2006 Year 11 Month 01 Day

Date of closure to data entry

2007 Year 02 Month 01 Day

Date trial data considered complete

2007 Year 02 Month 01 Day

Date analysis concluded

2007 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2006 Year 08 Month 15 Day

Last modified on

2011 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000570


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name