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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037615
Receipt No. R000042886
Scientific Title The effect of selective PPAR-alpha modulator to Non alcoholic fatty liver disease with dyslipidemia.
Date of disclosure of the study information 2019/10/01
Last modified on 2021/08/09

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Basic information
Public title The effect of selective PPAR-alpha modulator to Non alcoholic fatty liver disease with dyslipidemia.
Acronym The effect of selective PPAR-alpha modulator to Non alcoholic fatty liver disease with dyslipidemia.
Scientific Title The effect of selective PPAR-alpha modulator to Non alcoholic fatty liver disease with dyslipidemia.
Scientific Title:Acronym The effect of selective PPAR-alpha modulator to Non alcoholic fatty liver disease with dyslipidemia.
Region
Japan

Condition
Condition Non alcoholic fatty liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effect of SPAARM alpha on NAFLD with dyslipidemia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change in ALT at 12 weeks after medication
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 The patients with NAFLD shown ALT>31 U/L and TG>150mg/dL
Key exclusion criteria patients with cirrhosis
patients with gallstones
patients administered fibrate
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kanji
Middle name
Last name Yamaguchi
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code 6028566
Address 465 kajiityou, kamigyo-ku, kyoto
TEL 0752515519
Email yuyaseko@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Yuya
Middle name
Last name Seko
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code 6028566
Address 465 kajiityou, kamigyo-ku, kyoto
TEL 0752515519
Homepage URL
Email yuyaseko@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto Prefectural University of Medicine
Address 465 kajiityou, kamigyo-ku, kyoto
Tel 0752515519
Email yuyaseko@koto.kpu-m.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
2019 Year 10 Month 01 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 20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 08 Month 10 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 08 Month 06 Day
Date of IRB
2019 Year 09 Month 24 Day
Anticipated trial start date
2019 Year 09 Month 24 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We analyse the change in ALT, TG, and fibroscan in NAFLD patients with hyperlipidemia after 12weeks administration of pemmafibrate.

Management information
Registered date
2019 Year 08 Month 06 Day
Last modified on
2021 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042886

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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