UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001492 |
|---|---|
| Receipt number | R000001738 |
| Scientific Title | Pharmacogenetic study on the influence of aldehyde dehydrogenase 2 (ALDH2) gene polymorphism on the vasodilatation induced by organic nitrates |
| Date of disclosure of the study information | 2008/11/11 |
| Last modified on | 2011/03/30 17:42:45 |
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Basic information
Public title
Pharmacogenetic study on the influence of aldehyde dehydrogenase 2 (ALDH2) gene polymorphism on the vasodilatation induced by organic nitrates
Acronym
The influence of ALDH2 gene polymorphism on the effect of organic nitrates
Scientific Title
Pharmacogenetic study on the influence of aldehyde dehydrogenase 2 (ALDH2) gene polymorphism on the vasodilatation induced by organic nitrates
Scientific Title:Acronym
The influence of ALDH2 gene polymorphism on the effect of organic nitrates
Region
| Japan |
Condition
Condition
angina pectoris
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
By clinical trials in healthy volunteers, we will determine the relation between genetic polymorphism of the type 2 aldehyde dehydrogenase and the vasodilator action of nitroglycerine and isosorbide dinitrate to personalize the treatment with organic nitrates.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Ratio of maximal increase in brachial artery diameter
Time to attain maximal and 90% maximal dilatation of brachial artery
Key secondary outcomes
Pulse rate, blood pressure, and their post/pre-administration ratios
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
nitroglycerin
Interventions/Control_2
isosorbide dinitrate
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
| 20 | years-old | <= |
Age-upper limit
| 39 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Older than 20 and younger than 39
Healthy volunteers
Persons whose ALDH2 gene polymorphism is known
Key exclusion criteria
History of cardiovascular diseases
Serious liver damages
Serious renal damages
Pregnant women
History of adverse reaction to organic nitrates
Persons using sildenafil, vardenafil, or tadalafil
Systolic blood pressure less than 90 mmHg
Body weight less than 40 kg or more than 90 kg
Persons considered to be unsuitable to the study
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Sasaguri |
Organization
Faculty of Medical Sciences, Kyushu University
Division name
Department of Clinical Pharmacology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL
092-642-6080
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Sasaguri |
Organization
Faculty of Medical Sciences, Kyushu University
Division name
Department of Clinical Pharmacology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL
092-642-6080
Homepage URL
sasaguri@med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmacology, Faculty of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
九州大学病院（福岡県） Kyushu University Hospital, Fukuoka, Japan
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 11 | Month | 11 | 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
Completed
Date of protocol fixation
| 2008 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 10 | Day |
Last modified on
| 2011 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001738
