UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002292
Receipt number R000002799
Scientific Title Substudy of lipid lowering trial on prevention of atherosclerosis in 75 or older on cholesterol absorption and synthesis
Date of disclosure of the study information 2009/08/10
Last modified on 2015/06/02 09:59:36

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Basic information

Public title

Substudy of lipid lowering trial on prevention of atherosclerosis in 75 or
older on cholesterol absorption and synthesis

Acronym

EWTOPIA75-Kyushu

Scientific Title

Substudy of lipid lowering trial on prevention of atherosclerosis in 75 or
older on cholesterol absorption and synthesis

Scientific Title:Acronym

EWTOPIA75-Kyushu

Region

Japan


Condition

Condition

Hyper-LDL-cholesterolemia

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine Cardiology
Endocrinology and Metabolism Neurology Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of ezetimibe on cholesterol absorption-synthesis, inflammation markers and cardiovascular events.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

0 to 24weeks
(1)changes in cholesterol absorption and synthesis
(2)changes in inflammation markers
(3)changes in lipoproteins(RLPcholesterol, small dense LDL etc),
oxydised phospholipid, oxdised cholesterol)
(4)NT-proBNP

Key secondary outcomes

relation to composite
cardiovascular events (same as EWTOPIA75)


Base

Study type

Interventional


Study design

Basic design

Parallel

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

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

ezetimibe and diet

Interventions/Control_2

diet

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

75 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

same as EWTOPIA75

Key exclusion criteria

same as EWTOPIA75

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Jun Sasaki, MD,PhD

Organization

International University of Health and Welfare

Division name

Pharmaceutical Medicine

Zip code


Address

1-3-1 Nagahama Chuoku, Fukuoka, Japan

TEL

092-711-1126

Email



Public contact

Name of contact person

1st name
Middle name
Last name Jun Sasaki, MD.PhD

Organization

EWTO75-Kyushu group

Division name

EWTOPIA-Kyushu group office

Zip code


Address

1-3-1 Nagahama Chuoo-ku, Fukuoka, Japan

TEL

092-711-1126

Homepage URL


Email

fukuoka-shiken@iuhw.ac.jp


Sponsor or person

Institute

International University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

International University of Health and Welfare

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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



Other administrative information

Date of disclosure of the study information

2009 Year 08 Month 10 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

2009 Year 03 Month 25 Day

Date of IRB


Anticipated trial start date

2009 Year 08 Month 01 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 08 Month 04 Day

Last modified on

2015 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002799


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name