UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000119
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute National Cardiovascular Center
Institute
Department

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
URL(English) https://upload.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


Contact us.