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 |
* 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
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
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
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
