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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035248
Receipt No. R000040162
Scientific Title Safety and efficacy of pemafibrate (Parmodia) for patients having dyslipidemia and non-alcoholic fatty liver disease (NAFLD)
Date of disclosure of the study information 2018/12/13
Last modified on 2018/12/13

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Basic information
Public title Safety and efficacy of pemafibrate (Parmodia) for patients having dyslipidemia and non-alcoholic fatty liver disease (NAFLD)
Acronym Safety and efficacy of pemafibrate (Parmodia) for patients having dyslipidemia and non-alcoholic fatty liver disease (NAFLD)
Scientific Title Safety and efficacy of pemafibrate (Parmodia) for patients having dyslipidemia and non-alcoholic fatty liver disease (NAFLD)
Scientific Title:Acronym Safety and efficacy of pemafibrate (Parmodia) for patients having dyslipidemia and non-alcoholic fatty liver disease (NAFLD)
Region
Japan

Condition
Condition Patients with dyslipidemia and non-alcoholic fatty liver disease (NAFLD)
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of pemafibrate for NAFLD
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in liver enzymes at 24 and 48 weeeks after commencing the treatment
Key secondary outcomes Changes in liver fat/visceral fat calculated by CT and blood lipid, glucose, inflammation markers

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 pemafibrate 0.1mg x2/day, max 0.2mg x2/day, 48 weeks.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. Fasting triglyceride > 150 mg/dL, or LDL-C > 140 mg/dL, or HDL-C < 40mg/dL.
2. NAFLD with ALT > 40 U/L
3. Good activity of daily life and NO serious diseases
4. NO renal dysfunction
5. Agreement not to change daily activity and medications markedly
6. Agreement to undergo regular examination and medications
7. Agreement to participate in this trial by oneself
Key exclusion criteria 1. Creatinine > 1.5 mg/dL
2. Past history of myopathy and renal dysfunction by fibrate drugs
3. During Pregnancy and breast-feeding
4. Humans who were judged as not-suitable for this trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Tanaka
Organization Shinshu University School of Medicine
Division name Department of Metabolic Regulation
Zip code
Address Asahi 3-1-1, Matsumoto, Nagano
TEL 0263-37-2851
Email naopi@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Tanaka
Organization Shinshu University School of Medicine
Division name Department of Metabolic Regulation
Zip code
Address Asahi 3-1-1, Matsumoto, Nagano
TEL 0263-37-2851
Homepage URL
Email naopi@shinshu-u.ac.jp

Sponsor
Institute Shinshu University School of Medicine
Institute
Department

Funding Source
Organization NONE
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
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

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 13 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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 13 Day
Last modified on
2018 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040162

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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