UMIN-CTR Clinical Trial

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	Completed
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	2019 Year 02 Month 04 Day

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