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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004944
Receipt No. 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

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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
Email 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
Email huzui@u-fukui.ac.jp

Sponsor
Institute University of Fukui Faculty of Medical Sciences, Division of cardiovascular Medicine
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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