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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name