UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Beneficial effects of cholesterol absorption inhibitor,ezetimibe on impaired endothelial function in patients with metabolic syndrome.
Title of the study (Brief title)	EZET-trial
Region	Japan

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

Objectives
Narrative objectives1	To investigate effect of ezetimebe on endothelial function in patients with metabolic syndrome.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Rho-kinase activity FMD(flow-mediated dilation)
Key secondary outcomes	serum total and LDL cholesterol serum triglyceride cholesterol absorption marker adiponectin high sensitive CRP

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 not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ezetimibe 10mg daily,during the study period.
Interventions/Control_2	control
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	Patients who meet all of the following criteria. 1) Patients with Metabolic syndrome who are 20 years or older and less than 80 years at the entry. 2) Serum LDL cholesterol is 120mg/dl or over and less than 180mg/dl. 3) Patients who do not receive any lipid-lowering agents.
Key exclusion criteria	1) History of drug hypersensitivity to ezetimibe. 2) History of chronic heart failure. 3) Patients who have insulin therapy. 4) Patients who have severe liver dysfunction. Patients who have severe kidney dysfunction. 5) Patients who have secondary dyslipidemia or drug-induced dyslipidemia. 6) Pregnant or possibly pregnant patients. 7) Other patients deemed unsuitable as subjects of the study by the treating physician.
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroaki Shimokawa
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	1-1, Seiryo-machi, Aoba-ku, Sendai-city
TEL	022-717-7153
Email

Public contact
Name of contact person	Kotaro Nochioka
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	1-1, Seiryo-machi, Aoba-ku, Sendai-city
TEL	022-717-7153
Homepage URL
Email	nochioka@cardio.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine EZET-trial group
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 09 Month 12 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2008 Year 05 Month 15 Day
Anticipated trial start date	2008 Year 09 Month 01 Day
Last follow-up date	2012 Year 09 Month 01 Day
Date of closure to data entry	2012 Year 09 Month 01 Day
Date trial data considered complete	2012 Year 10 Month 01 Day
Date analysis concluded	2012 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2008 Year 08 Month 07 Day
Last modified on	2017 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001582