UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035248 |
|---|---|
| Receipt number | 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 19:22:39 |
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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
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
naopi@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040162
