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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002297
Receipt No. R000002803
Scientific Title Randomized control trial of effect of cholesterol absorption with ischemic heart disease patients.
Date of disclosure of the study information 2009/08/10
Last modified on 2015/01/19

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Basic information
Public title Randomized control trial of effect of cholesterol absorption with ischemic heart disease patients.
Acronym Ezetimibe and Statin Saved Endothelial Function Study.
Scientific Title Randomized control trial of effect of cholesterol absorption with ischemic heart disease patients.
Scientific Title:Acronym Ezetimibe and Statin Saved Endothelial Function Study.
Region
Japan

Condition
Condition Ischemic heart disease.
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of Ezetimibe, cholesterol absorption inhibitors, for endothelial function and metabolic factors.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Percent change of endothelial function.
Key secondary outcomes Comparison between two groups of serum lipid profile, adipocytokine, oxidative-stress and inframmatory marker, expression frequency of adverse effect due to the drugs.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Add ezetimibe 10mg daily.
Interventions/Control_2 Add atorvastatin 10mg daily.
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 Patients who treated with atorvastatin 10mg daily, and meet all of the following criterias;
1. LDL-Cholesterol over 70mg/dL.
2. Patients with ischemic heart disease.
3. Patients over 20 years old.
4. Patients who do not changed lipid altering agents in 4 weeks.
5. Patients who do not changed antidiabetes agent in 12 weeks, and has no remarkable change in glucose metabolism.
Key exclusion criteria 1. Patients who treated with insulin therapy.
2. HbA1c over 9%.
3. Patients who diagnosed of acute coronary syndrome in one month.
4. Patients who had history of anaphylaxis to the ezetimibe or atorvastatin.
5. AST over 100 IU/l or 127 IU/l.
6. Patients with secondary hyperlipidemia of drug-induced hyperlipidemia.
7. Patients who is pregnant or lactating.
8. Familial hyperlipidemia.
9. Other conditions precluding participation as judged by the investigator.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko MATSUMURA, M.D.
Organization Kameda General Hospital.
Division name Department of Cardiology.
Zip code
Address 929 Higashi-chou, Kamogawa-shi, Chiba, Japan.
TEL 0470-92-2211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuya MATSUE, M.D.
Organization Kameda General Hospital.
Division name Department of Cardiology.
Zip code
Address 929 Higashi-chou, Kamogawa-shi, Chiba, Japan.
TEL
Homepage URL
Email yuyam@kameda.jp

Sponsor
Institute Kameda General Hospital, department of cardiology.
Institute
Department

Funding Source
Organization Tokyo Medical Dental University, Bioethics Research Center.
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/circj/77/7/77_CJ-13-0033/_article
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
2009 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2012 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 05 Day
Last modified on
2015 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002803

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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