UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002297 |
|---|---|
| Receipt number | 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 18:01:04 |
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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
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
yuyam@kameda.jp
Sponsor or person
Institute
Kameda General Hospital, department of cardiology.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002803
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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