UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002935 |
|---|---|
| Receipt number | R000003570 |
| Scientific Title | A community-based surveillance of ezetimibe added to statin therapy for chronic kidney disease patients. |
| Date of disclosure of the study information | 2010/01/01 |
| Last modified on | 2009/12/24 05:52:47 |
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Basic information
Public title
A community-based surveillance of ezetimibe added to statin therapy for chronic kidney disease patients.
Acronym
A community-based surveillance of ezetimibe added to statin therapy for chronic kidney disease patients.
Scientific Title
A community-based surveillance of ezetimibe added to statin therapy for chronic kidney disease patients.
Scientific Title:Acronym
A community-based surveillance of ezetimibe added to statin therapy for chronic kidney disease patients.
Region
| Japan |
Condition
Condition
Chronic kidney disease stage 2-4
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Surveillance of ezetimibe added to statin therapy vs up-titration statin therapy foe CKD.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety Surveillance of ezetimibe added to statin therapy vs up-titration statin therapy
Key secondary outcomes
Efficacy Surveillance of ezetimibe added to statin therapy vs up-titration statin therapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Up-titration statin therapy
Interventions/Control_2
Ezetimibe Added-on statin therapy
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
| 35 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) CKD stage 2-4
2) LDL-C levels with statin therapy is 120mg/dL or more
3) Aged from 35 years to 75 years
Key exclusion criteria
1 total glyceride less than 400mg dl
2 liver enzyem less than 2 times the upper limit of normal]
3 patients withhomozygous familial hypercholesterolemia
4 patients with homozygous familial hypercholesterolemia
5 within 3 months of study entry of unstable angian, myocardial infarction, surgical coronary intervention or stroke
6 patients who are pregnant or nursing mohters, patients who may be pregnant, or patients who want to become pregnant during participation in the study
7 patients with a hisotry of hypersensitiivity to nay ingredient of ezetimibe tablets
8 other patients deemed not appropriate for study entry by the investigator
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromichi Suzuki |
Organization
Saitama Medical University
Division name
Department of Nephrology
Zip code
Address
38 Morohongo, Moroyama-machi,
TEL
049-276-1612
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Suzuki |
Organization
Saitama Medical University
Division name
Department of Nephrology
Zip code
Address
38 Morohongo, Moroyama-machi,
TEL
049-276-1620
Homepage URL
iromichi@saitama-med.ac.jp
Sponsor or person
Institute
Hiromichi Suzuki
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
埼玉医科大学病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 01 | 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 | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 24 | Day |
Last modified on
| 2009 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003570
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
