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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009105
Receipt No. R000010678
Scientific Title Influence of aldehyde dehydrogenase2 genotype on peripheral vasodilation, nitrate tolerance and oxidative stress by organic nitrates: randomized crossover trial
Date of disclosure of the study information 2012/10/15
Last modified on 2015/10/13

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Basic information
Public title Influence of aldehyde dehydrogenase2 genotype on peripheral vasodilation, nitrate tolerance and oxidative stress by organic nitrates: randomized crossover trial
Acronym Influence of aldehyde dehydrogenase2 genotype on the effects by organic nitrates
Scientific Title Influence of aldehyde dehydrogenase2 genotype on peripheral vasodilation, nitrate tolerance and oxidative stress by organic nitrates: randomized crossover trial
Scientific Title:Acronym Influence of aldehyde dehydrogenase2 genotype on the effects by organic nitrates
Region
Japan

Condition
Condition angina pectoris
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To determine the effects of aldehyde dehydrogenase 2 genotype on peripheral vasodilation, nitrate tolerance and oxidative stress after the administration of nitroglycerine and isosorbide dinitrate by clinical trials in Japanese healthy volunteer.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Relation between aldehyde dehydrogenase 2 genotype and the changes of peripheral vasodilation, nitrate tolerance and oxidative stress after single and multiple administration of organic nitrates
Key secondary outcomes Pulse rate, blood pressure and their post/pre-administration ratios
Ratio of side effects by organic nitrate

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
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
40 years-old >
Gender Male and Female
Key inclusion criteria Japanese healthy volunteers who are older than 20 and younger than 40
Key exclusion criteria 1. History of cardiovascular disease
2. severe hepatic dysfunction
3. severe renal dysfunction
4. woman who is pregnant or possibly be pregnant
5. History of severe allergy or allergic reaction to nitroglycerin and isosorbide dinitrate
6. History of glaucoma
7. On medical treatment
8. On medical treatment of phosphodiesterase 5
9. Systolic blood pressure <90 mmHg
10. Body weight <40 kg or >90 kg
11. Not appropriate to this study by other reasons
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sasaguri Toshiyuki
Organization Faculty of Medical Sciences, Kyushu University
Division name Department of Clinical Pharmacology
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka
TEL 092-642-6082
Email sasaguri@clipharm.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Yoshihara
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 092-642-6082
Homepage URL
Email tatsuya@clipharm.med.kyushu-u.ac.jp

Sponsor
Institute Department of Clinical Pharmacology, Faculty of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization Self funding
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
2012 Year 10 Month 15 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
2012 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 12 Day
Last modified on
2015 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010678

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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