UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000119
Receipt number R000000176
Scientific Title Gene evaluation for antihypertensive drug effects study
Date of disclosure of the study information 2005/09/07
Last modified on 2007/04/02 17:35:49

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Basic information

Public title

Gene evaluation for antihypertensive drug effects study

Acronym

GEANE study

Scientific Title

Gene evaluation for antihypertensive drug effects study

Scientific Title:Acronym

GEANE study

Region

Japan


Condition

Condition

essential hypertension

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Geriatrics

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To identify gene polymorphisms relating to blood pressure lowering effect of antihypertensive drugs

Basic objectives2

Others

Basic objectives -Others

To identify gene polymorphisms relationg to blood pressure lowering effect of thiazide diuretics, calcium channel blocker, angiotensin II receptor blocker

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

gene polymorphisms relating to blood pressure lowering effect of thiazide diuretics, calcium channel blocker, angiotensin II receptor blocker

Key secondary outcomes

gene polymorphisms relating to side effects of thiazide diuretics, calcium channel blocker, angiotensin II receptor blocker


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

thiazide diuretics
indapamide

Interventions/Control_2

calcium channel blocker
amlodipine

Interventions/Control_3

angiotensin II receptor blocker
valsartan

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

mild to moderate essential hypertension

Key exclusion criteria

severe hypertension (more than 180 and/or 110 mmHg)
secondary hypertension
female with pregnancy

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuhei Kawano

Organization

National Cardiovascular Center

Division name

Division of Hypertension and Nephrology

Zip code


Address

5-7-1, Fujishirodai, Suita, Osaka 565-8565

TEL

06-6833-5012

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kei Kamide

Organization

National Cardiovascular Center

Division name

Division of Hypertension and Nephrology

Zip code


Address

5-7-1, Fujishirodai, Suita, Osaka 565-8565

TEL

06-6833-5012

Homepage URL


Email

kamide@hsp.ncvc.go.jp


Sponsor or person

Institute

National Cardiovascular Center

Institute

Department

Personal name



Funding Source

Organization

Research grant from the Japanese Ministry of Health, Labor, and Welfare

Organization

Division

Category of Funding Organization

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

2005 Year 09 Month 07 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

Date of protocol fixation

2003 Year 06 Month 17 Day

Date of IRB


Anticipated trial start date

2004 Year 04 Month 01 Day

Last follow-up date

2008 Year 03 Month 01 Day

Date of closure to data entry

2009 Year 03 Month 01 Day

Date trial data considered complete

2009 Year 03 Month 01 Day

Date analysis concluded

2009 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 09 Month 06 Day

Last modified on

2007 Year 04 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000176


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name