UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001224
Receipt number R000001471
Scientific Title Effect of Fenofibrate and Ezetimibe Combination Treatment on Lipid
Date of disclosure of the study information 2008/07/01
Last modified on 2020/06/03 14:08:26

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Basic information

Public title

Effect of Fenofibrate and Ezetimibe Combination Treatment on Lipid

Acronym

EFECTL Study

Scientific Title

Effect of Fenofibrate and Ezetimibe Combination Treatment on Lipid

Scientific Title:Acronym

EFECTL Study

Region

Japan


Condition

Condition

Type IIb Dyslipidaemia

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of the safety and the efficancy of fenofibrate, ezetimibe and combined therapy from baseline to 1 year treatment in patients with type IIb dyslipidaemia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Per cent change in LDL-C from baseline
Per cent change in TG from baseline

Key secondary outcomes

Incidence rate (AE)
Per cent change in HDL-C from baseline


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking


Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Fenofibrate(200mg)+Ezetimibe(10mg)group 52 weeks

Interventions/Control_2

Fenofibrate(200mg) group
52 weeks

Interventions/Control_3

Ezetimibe(10mg) group
52 weeks

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Main criteria for inclusion:
Wash Out period;-4 weeks

1)Subjects who are able to give written informed consent

2)Male and female, and age is over 20 years

3)Patients with combined
hyperlipidaemia ;400>TG>200mg/dL
and LDL-C>140mg/dL

Key exclusion criteria

Main criteria for exclusion:
Wash Out period;-8 weeks

1)Patients who have received
probucol in the past 1 year

2)Patients with familial hypercholesterolemia

3)Patients with hyperlipidaemia caused by steroid hormone

4)Patients who have a clinical relevant history or presence as follows malignant neoplasm, thyroid disease,
HbA1c>8%, pancreatitis, active liver disease(AST or ALT>200% of UNL or 80IL), Creatinine>1.5mg/dL, gallstone, gallbladder, drugs or alcohol abuse, after patient must no have coronary heart disease and Cerebral Vascular Accident in the past 3 months, uncontrolled arrhythmia

5)History of significant sensitivity
to any drug, including fenofibrate
and ezetimibe

6)Patients who cannot discontinue
the contraindicated medications

7)Pregnant or breast-feeding female

8)Considered by the investigator,
for any reason, to be unsuitable
candidate for receiving fenofibrate
or ezetimibe

9) Patients who have an excellent
physical condition under present
treatment

10) Patients who are otherwise judged inappropriate for inclusion in the study by the investigators

Target sample size

280


Research contact person

Name of lead principal investigator

1st name Shinichi
Middle name
Last name OIKAWA

Organization

Nippon Medical School Faculty of
Medicine

Division name

Division of Endocrinology and

Zip code

113-8603

Address

1-1-5 Sendagi, Bunkyoku Tokyo

TEL

03-3822-2131

Email

csp-ld@csp.or.jp


Public contact

Name of contact person

1st name Study support centre
Middle name
Last name Study support centre

Organization

Public Health Research Foundation

Division name

Lifestyle-related disease clinical study support office

Zip code

169-0051

Address

1-1-7 Nishi-Waseda, Shinjuku-ku 169-0051

TEL

03-5287-2633

Homepage URL

http://www.csp.or.jp/

Email

csp-ld@csp.or.jp


Sponsor or person

Institute

Comprehensive Support Project for Life-style related disease (CSP-LD)

Institute

Department

Personal name



Funding Source

Organization

Aska Pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Public Health Research Foundation (PHRF)

Address

1-1-7-3F Nishiwaseda,shinjyuku-ku,Tokyo,169-0051

Tel

03-5287-2633

Email

csp-ld@csp.or.jp


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

2008 Year 07 Month 01 Day


Related information

URL releasing protocol

https://www.jstage.jst.go.jp/article/jat/24/1/24_35626/_article

Publication of results

Published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/jat/24/1/24_35626/_article

Number of participants that the trial has enrolled

236

Results

https://www.jstage.jst.go.jp/article/jat/24/1/24_35626/_article

Results date posted

2019 Year 05 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

https://www.jstage.jst.go.jp/article/jat/24/1/24_35626/_article

Participant flow

https://www.jstage.jst.go.jp/article/jat/24/1/24_35626/_article

Adverse events

https://www.jstage.jst.go.jp/article/jat/24/1/24_35626/_article

Outcome measures

https://www.jstage.jst.go.jp/article/jat/24/1/24_35626/_article

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2008 Year 06 Month 02 Day

Date of IRB

2008 Year 06 Month 02 Day

Anticipated trial start date

2008 Year 07 Month 01 Day

Last follow-up date

2014 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 06 Month 30 Day

Last modified on

2020 Year 06 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001471


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name