UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy Ezetimibe for dyslipidemia: A prospective cohort study
Acronym	Efficacy Ezetimibe for dyslipidemia: A prospective cohort study
Scientific Title	Efficacy Ezetimibe for dyslipidemia: A prospective cohort study
Scientific Title:Acronym	Efficacy Ezetimibe for dyslipidemia: A prospective cohort study
Region	Japan

Condition
Condition	Dyslipidemia during statin treatment
Classification by specialty	Cardiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy Ezetimibe
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	LDL
Key secondary outcomes	1) HDL, T-cho, TG 2) BUN, Cr, AST, ALT, CK, HbA1c 3) cystatin C, oxidized LDL, fatty acid fractionation, Lp (a), 4) Lipo fractionation, remnant-Like Particle 5) FMD, carotid echo, ABI 6) Cardiovascular events

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Dyslipidemia using statin
Key exclusion criteria	Patients who were deemed not appropriate to participate in this study by doctor
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Sezai
Organization	Nihon University School of Medicine
Division name	Department of Cardiovascular Surgery
Zip code	1738610
Address	30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Email	asezai.med@gmail.com

Public contact
Name of contact person	1st name Akira Middle name Last name Sezai
Organization	Nihon University School of Medicine
Division name	Department of Cardiovascular Surgery
Zip code	1738610
Address	30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Homepage URL
Email	asezai.med@gmail.com

Sponsor
Institute	Sekino Hospital
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	Sekino Laboratory
Address	3-28-3 ikebukuro, Toshima-ku, Tokyo, Japan
Tel	03-3986-5501
Email	asezai.med@gmail.com

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	関野病院（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 06 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	No longer recruiting
Date of protocol fixation	2018 Year 01 Month 01 Day
Date of IRB	2018 Year 01 Month 15 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective cohort study

Management information
Registered date	2019 Year 08 Month 06 Day
Last modified on	2020 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042879