UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040522 |
|---|---|
| Receipt number | R000046257 |
| Scientific Title | Examination of the carotid plaque improvement effect of the polyunsaturated fatty acid on patients with dyslipidemia |
| Date of disclosure of the study information | 2020/05/26 |
| Last modified on | 2020/05/26 12:48:37 |
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Basic information
Public title
Examination of the carotid plaque improvement effect of the polyunsaturated fatty acid on patients with dyslipidemia
Acronym
The carotid plaque improvement effect of the polyunsaturated fatty acid on patients with dyslipidemia
Scientific Title
Examination of the carotid plaque improvement effect of the polyunsaturated fatty acid on patients with dyslipidemia
Scientific Title:Acronym
The carotid plaque improvement effect of the polyunsaturated fatty acid on patients with dyslipidemia
Region
| Japan |
Condition
Condition
Patients with dyslipidemia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of EPA preparation or EPA+DHA preparation on carotid plaque in patients with hyperlipidemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Carotid IMT-C10
Key secondary outcomes
Carotid maxIMT, LDL-C, HDL-C, TG, nonHDL-C, EPA, DHA, AA, DHLA, LP(a), RLP-C
SAA-LDL, AT-LDL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
EPA: 1.8g/day for 24 weeks
Interventions/Control_2
EPA+DHA: 2g/day for 24 weeks
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
(1) Patient with dyslipidemia have already continued the treatment of statin more than three months, and curative effect is inadequate.
(2) Patient who does not take EPA preparation, EPA+DHA preparation or a supplement containing DHA and EPA.
(3) Patient at the agreement acquisition 20 years or older
(4) The patient that a written agreement was provided by the free will of the person after enough understanding about The participation in this study
Key exclusion criteria
(1) The patient who having unstable angina before registration or has the myocardial infarction past of the onset for less than three months at registration
(2) The patient who takes EPA preparation and EPA+DHA preparation
(3) Hospitalized patient
(4) The patient who has an allergy for a blue-skinned fish
(5) During the pregnancy or the woman who is nursing it
(6) It is the patients with in treatment or terminal cancer for a malignant tumor
(7) When I judge a study responsibility doctor, a study allotment doctor not to be appropriate about the participation of this study
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Morimoto |
Organization
University of Shizuoka
Division name
Division of Molecular Medicine, Graduate School of Pharmaceutical Sciences
Zip code
4228526
Address
52-1, Yata, Suruga-ku, Shizuoka, Shizuoka
TEL
0542645765
morimoto@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Morimoto |
Organization
University of Shizuoka
Division name
Division of Molecular Medicine, Graduate School of Pharmaceutical Sciences
Zip code
4228526
Address
52-1, Yata, Suruga-ku, Shizuoka, Shizuoka
TEL
0542645765
Homepage URL
morimoto@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Shizuoka General Hospital
Address
4-27-1,Kitaando, Aoi-ku, Shizuoka, Shizuoka
Tel
momoko-maejima@shizuoka-pho.jp
054-247-6111
Secondary IDs
Secondary IDs
YES
Study ID_1
SGHIRB#2019032
Org. issuing International ID_1
Shizuoka General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
静岡県立総合病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 26 | Day |
Last modified on
| 2020 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046257
| Research Plan | |
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| Registered date | File name |
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