UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053992 |
|---|---|
| Receipt number | R000061638 |
| Scientific Title | Clinical study of switching from pemafibrate IR to XR |
| Date of disclosure of the study information | 2024/03/28 |
| Last modified on | 2024/03/28 13:51:16 |
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Basic information
Public title
Clinical study of switching from pemafibrate IR to XR
Acronym
Clinical study of switching from pemafibrate IR to XR
Scientific Title
Clinical study of switching from pemafibrate IR to XR
Scientific Title:Acronym
Clinical study of switching from pemafibrate IR to XR
Region
| Japan |
Condition
Condition
Hypertriglyceridemia while taking pemafibrate IR
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observe the efficacy of pemafibrate XR
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TG
Key secondary outcomes
1) LDL, HDL, T-cho
2) sCr, eGFR , AST, ALT
3)Remnant-Like Particle, fatty acid fractionation
4) oxidized LDL, hs-CPR
5) side effects
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Triglyceridemia while taking pemafibrate IR
Key exclusion criteria
Patients who were deemed not appropriate to participate in this study by doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Sezai |
Organization
Nihon University School of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
1738610
Address
30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
asezai.med@gmail.com
Public contact
Name of contact person
| 1st name | Mitsue |
| Middle name | |
| Last name | Akiyama |
Organization
Sekino Laboratory
Division name
Department of Research
Zip code
1710014
Address
3-28-3 ikebukuro, Toshima-ku, Tokyo, Japan
TEL
03-3986-5501
Homepage URL
skn-np@sekino-hospital.com
Sponsor or person
Institute
Sekino Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Sekino Laboratory
Address
3-28-3 ikebukuro, Toshima-ku, Tokyo, Japan
Tel
03-3986-5501
skn-np@sekino-hospital.com
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
関野病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 28 | 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
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Switch from pemafubrate IR to XR (same daily dormitory dose)
Observation for 6 months after switching
Management information
Registered date
| 2024 | Year | 03 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061638
