UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037110
Receipt number R000042033
Scientific Title Prospective randomized trial on Pemafibrate versus omega-3-acid ethyl in patients with treated hypertriglyceridemia
Date of disclosure of the study information 2019/06/19
Last modified on 2021/04/26 14:53:56

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Basic information

Public title

Prospective randomized trial on Pemafibrate versus omega-3-acid ethyl in patients with treated hypertriglyceridemia

Acronym

Prospective randomized trial on Pemafibrate versus omega-3-acid ethyl in patients with treated hypertriglyceridemia

Scientific Title

Prospective randomized trial on Pemafibrate versus omega-3-acid ethyl in patients with treated hypertriglyceridemia

Scientific Title:Acronym

Prospective randomized trial on Pemafibrate versus omega-3-acid ethyl in patients with treated hypertriglyceridemia

Region

Japan


Condition

Condition

Hypertriglyceridemia

Classification by specialty

Cardiology Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is a comparative study of Pemafibrate and omega 3 fatty acid ethyl for hypertriglyceridemia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

TG

Key secondary outcomes

LDL,HDL,T-cho,sCr,eGFR
Remnant-Like Particle,Apo A-I,B,E,fatty acid fractionation,urinary albumin,cystitis C,oxidized LDL
Cartotid echo,ABI,FMD


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



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pemafibrate 0.2mg/day

Interventions/Control_2

omega 3 fatty acid ethyl 2g/day

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

Patients being treated for hypertriglyceridemia

Key exclusion criteria

sCr>1.5mg/dL(treating with statin)
sCr>2.5mg/dL(untreating with statin)
Patients who were deemed not appropriate to participate in this study by doctor

Target sample size

40


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 Mitsue
Middle name
Last name Akiyama

Organization

Sekino Laboratory

Division name

Department of Research

Zip code

1710014

Address

3-28-3 ikebukuro, Toshima-ku, Tokyo, Japan

TEL

03-3986-5501

Homepage URL


Email

skn-np@sekino-hospital.com


Sponsor or person

Institute

Sekino Hospital

Institute

Department

Personal name



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

skn-np@sekino-hospital.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 06 Month 19 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 10 Month 01 Day

Date of IRB

2018 Year 10 Month 22 Day

Anticipated trial start date

2019 Year 06 Month 20 Day

Last follow-up date

2022 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 06 Month 19 Day

Last modified on

2021 Year 04 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042033


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name