UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	comparison of pitavastatin versus EPA on lipid-lowering effect in patients with dyslipidemia
Title of the study (Brief title)	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	Hiroyasu Uzui
Organization	University of Fukui Faculty of Medical Sciences
Division name	Division of cardiovascular Medicine
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	Hiroyasu Uzui
Organization	University of Fukui Faculty of Medical Sciences
Division name	Division of cardiovascular Medicine
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000005885