UMIN-CTR Clinical Trial

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

Type IIb Dyslipidaemia

Classification by specialty

Medicine in general	Cardiology	Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Aska Pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

07

Month

01

Day

URL releasing protocol

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

Publication of results

Published

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

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 related 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