UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004024
Receipt number R000004840
Scientific Title evaluation of the effect for cardio vascular system by administrating EPA thrapy
Date of disclosure of the study information 2010/08/16
Last modified on 2011/07/27 09:22:08

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Basic information

Public title

evaluation of the effect for cardio vascular system by administrating EPA thrapy

Acronym

EPA trial

Scientific Title

evaluation of the effect for cardio vascular system by administrating EPA thrapy

Scientific Title:Acronym

EPA trial

Region

Japan


Condition

Condition

hyperlipidemia

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism
Vascular surgery Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

this study's objective is to cler the effect for cardiovascular system by administrating the EPA drugs.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1) FMD, ABI, pWV, IMA
2) Cardioechography
3) TG, HDL, LDL, MDA-LDL, lipd acid

Key secondary outcomes

1) liver function
2) Renal function
3) blood test(BNP, FBS, HbA1c, IRI)
5) BMI, waist


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Eicosapentaenoic acid

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

85 years-old >

Gender

Male

Key inclusion criteria

1) hyperlipidemia
2) age: 20-85 years old
3) sex:men, women

Key exclusion criteria

1) with allergy for anti-lipid drug
2) severe chronic renal failure
3) severe liver failure
4) hypo-drug compliance
5) the patients with pregnancy
6) the patients who was judged not to be able to admit drug by doctor

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirotsugu KUROBE

Organization

the university of TOKUSHIMA Graduate School

Division name

Cardiovascular Surgery

Zip code


Address

3-18-15 Kuramoto-chou, Tokushima-shi

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

the university of TOKUSHIMA Graduate School

Division name

Cardiovascular Surgery

Zip code


Address

3-18-15 Kuramoto-chou, Tokushima-shi

TEL


Homepage URL


Email



Sponsor or person

Institute

the university of Tokushima Graduate School

Institute

Department

Personal name



Funding Source

Organization

none

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


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

徳島大学病院


Other administrative information

Date of disclosure of the study information

2010 Year 08 Month 16 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

Preinitiation

Date of protocol fixation

2010 Year 08 Month 15 Day

Date of IRB


Anticipated trial start date

2010 Year 10 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

2010 Year 08 Month 10 Day

Last modified on

2011 Year 07 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004840


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name