UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013382 |
|---|---|
| Receipt number | R000015614 |
| Scientific Title | Effect of co-administration of HMG-CoA Reductase Inhibitor on the endothelial dysfunction after continuous treatment of nitroglycerin in Japanese volunteers with aldehyde dehydrogenase2 Glu487Lys genotypes: randomized crossover trial |
| Date of disclosure of the study information | 2014/03/11 |
| Last modified on | 2016/03/10 22:51:28 |
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Basic information
Public title
Effect of co-administration of HMG-CoA Reductase Inhibitor on the endothelial dysfunction after continuous treatment of nitroglycerin in Japanese volunteers with aldehyde dehydrogenase2 Glu487Lys genotypes: randomized crossover trial
Acronym
Effect of HMG-CoA Reductase Inhibitor on the endothelial dysfunction in Japanese volunteers with ALDH2 mutation
Scientific Title
Effect of co-administration of HMG-CoA Reductase Inhibitor on the endothelial dysfunction after continuous treatment of nitroglycerin in Japanese volunteers with aldehyde dehydrogenase2 Glu487Lys genotypes: randomized crossover trial
Scientific Title:Acronym
Effect of HMG-CoA Reductase Inhibitor on the endothelial dysfunction in Japanese volunteers with ALDH2 mutation
Region
| Japan |
Condition
Condition
angina pectoris
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To determine the effect of co-administration of HMG-CoA Reductase Inhibitor on the endothelial function after continuous treatment of nitroglycerin in Japanese healthy volunteers with aldehyde dehydrogenase2 Glu487Lys genotypes
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Relation between co-administration of atorvastatin and the change of flow-mediated dilation, oxidative stress and high-sensitivity CRP.
Relation between aldehyde dehydrogenase 2 genotype and the change of flow-mediated dilation, oxidative stress and high-sensitivity CRP.
Key secondary outcomes
Relation between co-administration and change of blood pressure, pulse rate, lipid parameter and side effects. Relation between ALDH2 genotype and change of blood pressure, pulse rate, lipid parameter and side effects.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Gene |
Interventions/Control_1
nitroglycerin 25 mg/day is transdermally administered for 7 days
Interventions/Control_2
nitroglycerin 25 mg/day and atorvastatin 20 mg/day are administered for 7 days
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 the drugs which are used in the present study
6. History of heart disease, glaucoma, peptic ulcer and aspirin-induced asthma
7. On medical treatment (exclude NSAIDs and sleeping pills taken as needed)
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
44
Research contact person
Name of lead principal investigator
| 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
TEL
092-642-6082
tatsuya@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
TEL
092-642-6082
Homepage URL
tatsuya@clipharm.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmacology, Faculty of Medical Sciences, Kyushu Univertisy
Institute
Department
Personal name
Funding Source
Organization
Japan Research Foundation for Clinical Pharmacology.
Grant of the clinical research promotion foundation.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Medical Co. LTA Hakata Clinic
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
| 2014 | Year | 03 | 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
| 2014 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | 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
| 2014 | Year | 03 | Month | 10 | Day |
Last modified on
| 2016 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015614
