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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001718
Receipt No. R000002056
Scientific Title Clinical study of the correlation between cholesterol absorption and coronary risk factors or arteriosclerotic diseases, and of the clinical significance of the controlling cholesterol absorption.
Date of disclosure of the study information 2009/02/23
Last modified on 2011/08/16

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Basic information
Public title Clinical study of the correlation between cholesterol absorption and coronary risk factors or arteriosclerotic diseases, and of the clinical significance of the controlling cholesterol absorption.
Acronym Clinical study of the inhibition of cholesterol absorption.
Scientific Title Clinical study of the correlation between cholesterol absorption and coronary risk factors or arteriosclerotic diseases, and of the clinical significance of the controlling cholesterol absorption.
Scientific Title:Acronym Clinical study of the inhibition of cholesterol absorption.
Region
Japan

Condition
Condition Hypercholesterolemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the association between the balance of cholesterol synthesis/absorption and coronary risk factors or arteriosclerotic diseases. We also assess clinical usefulness of Ezetimibe, a small intestine cholesterol transporter inhibitor.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Association between the cholesterol asynthesis/absorption markers before Ezetimibe administration and coronary risk factors or arteriosclerotic diseases.
2. Amount or rate of changes in LDL-C after Ezetimibe administration.
3. Correlation between the amount or rate of changes in LDL-C after Ezetimibe administration and the cholesterol synthesis/absorption markers.
Key secondary outcomes Changes of RLP-cholesterol, HDL-C, triglyceride, insulin, plasma glucose, HbA1c, and hs-CRP.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Twelve weeks Ezetimibe administration to the patients with hypercholesterolemia without statins.
Interventions/Control_2 Twelve weeks Ezetimibe administration to the patients with hypercholesterolemia taking statins.
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

Not applicable
Gender Male and Female
Key inclusion criteria Serum LDL-C level is higher than the management targeted value in Japan atherosclerosis society guidelines for prevention of atherosclerotic cardiovascular diseases 2007.
Key exclusion criteria Severe liver or renal dysfunction.
The patient using fibrate or insulin.
Secondary hypercholesterolemia.
Pregnant women.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masamitsu Nakazato
Organization Miyazaki Medical College, University of Miyazaki
Division name Neurology, Respirology, Endocrinology and Metabolism
Zip code
Address 5200, kihara, Kiyotake, Miyazaki, Japan
TEL 0985-85-2965
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Ueno
Organization Miyazaki Medical College, University of Miyazaki
Division name Neurology, Respirology, Endocrinology and Metabolism
Zip code
Address 5200, kihara, Kiyotake, Miyazaki, Japan
TEL 0985-85-2965
Homepage URL
Email intron@med.miyazaki-u.ac.jp

Sponsor
Institute Neurology, Respirology, Endocrinology and Metabolism,
Miyazaki Medical College, University of Miyazaki
Institute
Department

Funding Source
Organization Ministry of education, culture, sports, science & technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2009 Year 02 Month 23 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 Completed
Date of protocol fixation
2008 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 08 Month 01 Day
Date trial data considered complete
2011 Year 08 Month 01 Day
Date analysis concluded
2011 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 02 Month 19 Day
Last modified on
2011 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002056

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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