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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033639
Receipt No. R000038230
Official scientific title of the study Effect of co-administration of quercetin on the endothelial dysfunction after continuous treatment of nitroglycerin in Japanese volunteers with aldehyde dehydrogenase2 *2 polymorphism: randomized crossover trial
Date of disclosure of the study information 2018/08/06
Last modified on 2018/08/06

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Basic information
Official scientific title of the study Effect of co-administration of quercetin on the endothelial dysfunction after continuous treatment of nitroglycerin in Japanese volunteers with aldehyde dehydrogenase2 *2 polymorphism: randomized crossover trial
Title of the study (Brief title) Effect of quercetin on the endothelial dysfunction after nitroglycerine treatment in Japanese volunteers with ALDH2 *2 polymorphism
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 quercetin, which has antioxidant effect, on the endothelial function after continuous treatment of nitroglycerin in Japanese healthy volunteers with aldehyde dehydrogenase2 (ALDH2) *2 polymorphism
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relation between ALDH2 polymorphisms and the values of flow-mediated dilation, and oxidative stress (malondialdehyde).
Key secondary outcomes Relation between ALDH2 polymorphisms and blood pressure, pulse rate.
Relation between ALDH2 polymorphisms and the rate of adverse events.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 nitroglycerin 25 mg/day is transdermally administered for 7 days
Interventions/Control_2 nitroglycerin 25 mg/day and quercetin 1000mg/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
45 years-old >
Gender Male and Female
Key inclusion criteria Japanese healthy volunteers who are older than 20 and younger than 45
Volunteers who have ALDH2 *1/*1 or *2/*2
Key exclusion criteria 1.History of cardiovascular disease
2.Severe hepatic or renal dysfunction
3.Volunteers who received other clinical study drug within 30 days
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.volunteers who have smoking habit 3 months before the start of this study
8.On medical treatment (exclude NSAIDs and sleeping pills taken as needed)
9.On medical treatment of phosphodiesterase 5 or agents with guanylate cyclase stimulating effect
10.systolic blood pressure<90 mmHg
11.Body weight <40 kg or >90 kg
12.Not appropriate to this study by other reasons
Target sample size 24

Research contact person
Name of lead principal investigator Tatsuya Yoshihara
Organization SOUSEIKAI Fukuoka Mirai Hospital
Division name Clinical Research Center
Address 3-5-1, Kashiiteriha, Higashi-ku, Fukuoka
TEL 092-662-3608
Email tatsuya-yoshihara@lta-med.com

Public contact
Name of contact person Tatsuya Yoshihara
Organization SOUSEIKAI Fukuoka Mirai Hospital
Division name Clinical Research Center
Address 3-5-1, Kashiiteriha, Higashi-ku, Fukuoka
TEL 092-662-3608
Homepage URL
Email tatsuya-yoshihara@lta-med.com

Sponsor
Institute SOUSEIKAI Fukuoka Mirai Hospital, Clinical Research Center
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Graduate School of Medical Sciences, Kyushu Umiversity
Name of secondary funder(s)

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 医療法人相生会 福岡みらい病院 臨床研究センター

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 06 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 08 Month 03 Day
Anticipated trial start date
2018 Year 08 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 06 Day
Last modified on
2018 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038230

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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