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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002469
Receipt No. R000003023
Scientific Title Cholesterol lowerling effect of ezetimibe on hypercholesterolemic patients with type2 diabetes.
Date of disclosure of the study information 2009/09/08
Last modified on 2011/11/01

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Basic information
Public title Cholesterol lowerling effect of ezetimibe on hypercholesterolemic patients with type2 diabetes.
Acronym Zetia study
Scientific Title Cholesterol lowerling effect of ezetimibe on hypercholesterolemic patients with type2 diabetes.
Scientific Title:Acronym Zetia study
Region
Japan

Condition
Condition type2 diabetes patients with hypercholesterolemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the cholesterol lowering effect of diet thjerapy by hospitalyzation and treatment of ezetimibe on type2 diabetes patients with hypercholesterolemia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Reduction rate of LDL-C for 1 week after hospitalization.
2. Reduction rate of LDL-C after treatment of ezetimibe.
Key secondary outcomes 1. Reduction rate of TC, HDL-C, TG, RLP-C and sdLDL-C for 1 week after hospitalization.
2. Reduction rate of TC, HDL-C, TG, RLP-C and sdLDL-C after treatment of ezetimibe.
3. Correlation between markers of cholesterol synthesis or absorption and reduction rate of TC, LDL-C, HDL-C, TG, RLP-C and sdLDL-C for 1 week after hospitalization.
4. Correlation between markers of cholesterol synthesis or absorption and reduction rate of TC, LDL-C, HDL-C, TG, RLP-C and sdLDL-C after ezetimibe treatment.
5. Correlation between reduction rate of LDL-C for 1 week after hospitalization and reduction rate of LDL-C after ezetimibe treatment.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After hospitalization of type2 diabetes patients, they were treated with diet therapy of hypercholesterolemia (limit of cholesterol intake by less than 300 mg per day). After 1 week, they were treated with ezetimibe (10 mg/day) for 6 weeks.
Interventions/Control_2
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 Typr2 diabetes patients with hypercholesterolemia (LDL-c>120mg/dl), which are able to hospitalize.
Key exclusion criteria 1. patients with cerebrovasucular disease (onset within 12 weeks).
2. patients over 500 mg/dl of TG.
3. patients with cardiovascular disease.
4. patients with liver disfunction.
5. patients with renal disfunction.
6. patients who are estimated not to continue this study by serious diseases.
7. patients with familial hypercholesterolemia.
8. secondary hypercholesterolemia.
9. patients with alcholism or medicinal poisoning.
10. medicinal allergy.
11. patients with pregnancy.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Matsumura
Organization Graduate School of Medical Science, Kumamoto University.
Division name Department of Metabolic Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto, 860-8556, Japan.
TEL 096-373-5169
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Matsumura
Organization Graduate School of Medical Science, Kumamoto University.
Division name Department of Metabolic Medicine
Zip code
Address
TEL
Homepage URL
Email takeshim@gpo.kumamoto-u.ac.jp

Sponsor
Institute Department of Metabolic Medicine, Graduate School of Medical Science, Kumamoto University.
Institute
Department

Funding Source
Organization Department of Metabolic Medicine, Graduate School of Medical Science, Kumamoto University.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 熊本大学医学部附属病院(熊本県)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 08 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 Open public recruiting
Date of protocol fixation
2009 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
2013 Year 02 Month 01 Day
Date trial data considered complete
2013 Year 08 Month 01 Day
Date analysis concluded
2014 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 08 Day
Last modified on
2011 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003023

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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