UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003008 |
|---|---|
| Receipt number | R000003643 |
| Scientific Title | evaluation of the effect for cardio vascular system by administrating the anti-lipid thrapy |
| Date of disclosure of the study information | 2010/03/01 |
| Last modified on | 2011/07/27 09:23:24 |
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Basic information
Public title
evaluation of the effect for cardio vascular system by administrating the anti-lipid thrapy
Acronym
EECVS test
Scientific Title
evaluation of the effect for cardio vascular system by administrating the anti-lipid thrapy
Scientific Title:Acronym
EECVS test
Region
| Japan |
Condition
Condition
hyperlipidemia
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
this study's objective is to cler the effect for cardiovascular system by administrating the anti-lipd drugs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) FMD, ABI, pWV, IMA
2) Cardioechography
3) TG, HDL, LDL, MDA-LDL
Key secondary outcomes
1) liver function
2) Renal function
3) blood test(BNP, FBS, HbA1c, IRI)
5) BMI, waist
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rosvastatin (50 cases)
Interventions/Control_2
ezetimibe(50 cases)
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) hyperlipidemia
2) age: 20-85 years old
3) sex:men, women
Key exclusion criteria
1) with allergy for anti-lipid drug
2) severe chronic renal failure
3) severe liver failure
4) hypo-drug compliance
5) the patients with pregnancy
6) the patients who was judged not to be able to admit drug by doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu KUROBE |
Organization
the university of TOKUSHIMA Graduate School
Division name
Cardiovascular Surgery
Zip code
Address
3-18-15 Kuramoto-chou, Tokushima-shi
TEL
+81-88-633-7581
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotsugu KUROBE |
Organization
the university of TOKUSHIMA
Division name
cardiovascular surgery
Zip code
Address
3-18-15 Kuramoto-chou, Tokushima-shi
TEL
088-633-7581
Homepage URL
hp@tokushima-cvs.info
Sponsor or person
Institute
the university of Tokushima Graduate School
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
徳島大学病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 10 | Day |
Last modified on
| 2011 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003643
