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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008049
Receipt No. R000009480
Scientific Title Efficacy of Ezetimibe vs Rosuvastatin In Impaired Glucose Tolerance Hypercholesterolemia to Treat
Date of disclosure of the study information 2012/05/30
Last modified on 2016/08/25

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Basic information
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
Condition Hypercholesterolemia
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

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 a block.
Blocking YES
Concealment Central registration

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Jikei University School of Medicine,Kashiwa Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kashiwa Heart Clinic
Fujiki Clinic
Takeda Clinic
Nedo Clinic
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 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)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 30 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 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
Other related information

Management information
Registered date
2012 Year 05 Month 29 Day
Last modified on
2016 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009480

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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