UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004944 |
|---|---|
| Receipt number | R000005885 |
| Scientific Title | comparison of pitavastatin versus EPA on lipid-lowering effect in patients with dyslipidemia |
| Date of disclosure of the study information | 2011/01/25 |
| Last modified on | 2018/08/01 11:31:24 |
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Basic information
Public title
comparison of pitavastatin versus EPA on lipid-lowering effect in patients with dyslipidemia
Acronym
comparison of pitavastatin versus EPA in patients with dyslipidemia
Scientific Title
comparison of pitavastatin versus EPA on lipid-lowering effect in patients with dyslipidemia
Scientific Title:Acronym
comparison of pitavastatin versus EPA in patients with dyslipidemia
Region
| Japan |
Condition
Condition
dyslipidemia
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
comparison of pitavastatin 2mg/day alone versus EPA 1800mg/day alone on lipid-lowering effect in dyslipidemic patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
comparison of changes of LOX-1 ligand density and MT1-MMP expression rate
Key secondary outcomes
comparison of change or %change of TC, TG, HDL-C, LDL-C, hs-CRP, sLOX-1 density and the fatty acid compartment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pitavastatin 2 mg/day for 6 months
Interventions/Control_2
EPA 1800 mg/day for 6 months
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1,Dyslipidemic patients whose serum LDL-C levels are more than 140 mg/dL or TC levels are more than 220 mg/dL
2,Patients who provided written informed consent. The study protocol was approved by the Ethics Committee of Fukui University.
Key exclusion criteria
1,pregnant, breast feeding, or could be pregnant
2,severe liver diseases
3,severe kidney diseases
(eGFR<30 mL/min/1.73m2)
4,history of allergic reaction to Pitavastatin or EPA
5,Physician does not agree to join the trial
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Uzui |
Organization
University of Fukui Faculty of Medical Sciences
Division name
Division of cardiovascular Medicine
Zip code
Address
23-3 Shimoaizuki, Eiheiji-cho, Fukui 910-1193, Japan.
TEL
0776-61-3111
huzui@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Uzui |
Organization
University of Fukui Faculty of Medical Sciences
Division name
Division of cardiovascular Medicine
Zip code
Address
23-3 Shimoaizuki, Eiheiji-cho, Fukui 910-1193, Japan.
TEL
0776-61-3111
Homepage URL
huzui@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui Faculty of Medical Sciences, Division of cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanazawa Medical University Hospital The 21st Century Multidisciplinary Medical Center
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
福井大学医学部附属病院(福井県)、金沢医科大学病院(石川県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
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
Main results already published
Date of protocol fixation
| 2010 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 05 | 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
| 2011 | Year | 01 | Month | 25 | Day |
Last modified on
| 2018 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005885
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
