UMIN-CTR Clinical Trial

Public title

Efficacy of Ezetimibe vs Rosuvastatin In Impaired Glucose Tolerance Hypercholesterolemia to Treat

Acronym

Efficacy of Ezetimibe vs Rosuvastatin In Impaired Glucose Tolerance Hypercholesterolemia to Treat (E-RIGHT study)

Scientific Title

Efficacy of Ezetimibe vs Rosuvastatin In Impaired Glucose Tolerance Hypercholesterolemia to Treat

Scientific Title:Acronym

Efficacy of Ezetimibe vs Rosuvastatin In Impaired Glucose Tolerance Hypercholesterolemia to Treat (E-RIGHT study)

Region

Japan

Condition

Hypercholesterolemia

Classification by specialty

Medicine in general	Cardiology	Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

1. To investigate the clinical effect of ezetimibe on LDL-cholesterol(LDL-C), other serum lipids and glucose metabolism in hypercholesterolemia patients with impaired glucose tolerance
2. To clarify beneficial patients of ezetimibe treatment

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Comparison of LDL-C level between groups

Key secondary outcomes

Changes and comparison of
each serum lipid level, Apolipo protein level, glucose metabolism level, laboratory test level, atherosclerosis index level, BMI, waist circumference, adverse event

Study type

Interventional

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 a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Statin treatment
Rosuvastatin 5mg

Interventions/Control_2

Combination treatment
Rosuvastatin 2.5mg + ezetimibe 10mg

Interventions/Control_3

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) LDL-C level exceeds target LDL-C level(Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007) after at least 4 weeks of rosuvastatin treatment
2) 5.5%<=HbA1c(NGSP)<6.5% or 110mg/dL<=fasting blood glucose<126mg/dL

Key exclusion criteria

1) HbA1c>=6.5%(NGSP)
2) Hypersensitivity to test agents
3) Treating with antihyperlipidemic agents other than rosuvastatin
4) Severe hepatic dysfunction: any one of following
(i)AST>=100IU/L
(ii)ALT>=100IU/L
(iii)Cirrhosis
5) Severe renal dysfunction: serum creatinine>=2.0mg/dL
6) History of acute coronary syndrome(myocardial infarction, angina) and stroke within 3 months
7) Secondary hyperlipidemia, drug induced hyperlipidemia
8) Pregnant, breast-feeding, becoming pregnant
9) Familial hypercholesterolemia
10) Inadequate to this study

Target sample size

150

Name of lead principal investigator

1st name
Middle name
Last name	Mitsuyuki SHIMIZU

Organization

Jikei University School of Medicine,Kashiwa Hospital

Division name

Division of Cardiology Department of Internal Medicine

Zip code

Address

163-1, Kashiwashita, Kashiwa city, Chiba

TEL

04-7164-1111

Email

Name of contact person

1st name
Middle name
Last name	Mitsuyuki SHIMIZU

Organization

Jikei University School of Medicine,Kashiwa Hospital

Division name

Division of Cardiology Department of Internal Medicine

Zip code

Address

163-1, Kashiwashita, Kashiwa city, Chiba

TEL

04-7164-1111

Homepage URL

Email

Institute

Jikei University School of Medicine,Kashiwa Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Kashiwa Heart Clinic
Fujiki Clinic
Takeda Clinic
Nedo Clinic

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京慈恵会医科大学付属柏病院(千葉県)
東京慈恵会医科大学附属病院(東京都)
医療法人社団　慈雅会　柏ハートクリニック(千葉県)
医療法人社団　藤木医院(千葉県)
竹田内科医院(千葉県)
根戸クリニック(千葉県)

Date of disclosure of the study information

2012

Year

05

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2011

Year

07

Month

22

Day

Date of IRB

Anticipated trial start date

2011

Year

10

Month

01

Day

Last follow-up date

2012

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

05

Month

29

Day

Last modified on

2016

Year

08

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009480