UMIN-CTR Clinical Trial

Basic information
Public title	Effect of fibrate to liver enzyme in the patients with dyslipidemia
Acronym	Liver enzyme and fibrate at dyslipidemia
Scientific Title	Effect of fibrate to liver enzyme in the patients with dyslipidemia
Scientific Title:Acronym	Liver enzyme and fibrate at dyslipidemia
Region	Japan

Condition
Condition	Dyslipidemia
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of fibrate to liver enzyme
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Liver enzyme after administration of fibrate
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Diagnosis of dyslipidemia prior to the study
Key exclusion criteria	Complicated with malignancy Disagree with registration of the study
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Takikawa
Organization	Iwate medical university
Division name	Division
Zip code	028-3694
Address	Idaidori 1-1-1, Yahaba cho, Iwate
TEL	019-651-5111
Email	keikaki@iwate-med.ac.jp

Public contact
Name of contact person	1st name Keisuke Middle name Last name Kakisaka
Organization	Iwate medical university
Division name	Division of Hepatology, Department of Internal Medicine
Zip code	028-3694
Address	Idaidori 1-1-1, Yahaba cho, Iwate
TEL	0196515111
Homepage URL
Email	keikaki@iwate-med.ac.jp

Sponsor
Institute	Iwate medical university
Institute
Department

Funding Source
Organization	Iwate medical university
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	Iwate medical university
Address	Idaidori 1-1-1, Yahaba cho, Iwate
Tel	0196515111
Email	kenkyu-rinri@j.iwate-med.ac.jp

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

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 24 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	297
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	No longer recruiting
Date of protocol fixation	2021 Year 03 Month 05 Day
Date of IRB	2021 Year 03 Month 05 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2021 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Laboratory data of the patients with dyslipidemia between 1/1/2015 and 11/30/2020 were corrected.

Management information
Registered date	2021 Year 06 Month 23 Day
Last modified on	2021 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050980