UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041837 |
|---|---|
| Receipt number | R000047747 |
| Scientific Title | A prospective observational multi center trial for safety and benefit of Pemafibrate in medical practitioner |
| Date of disclosure of the study information | 2020/09/18 |
| Last modified on | 2023/05/22 10:28:28 |
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Basic information
Public title
Safety and benefit of Pemafibrate in medical practitioner
Acronym
PAR-CHAT
(PARMODIA-Chikushi-Anti-Dyslipidemia Trial)
Scientific Title
A prospective observational multi center trial for safety and benefit of Pemafibrate in medical practitioner
Scientific Title:Acronym
PAR-CHAT
(PARMODIA-Chikushi-Anti-Dyslipidemia Trial)
Region
| Japan |
Condition
Condition
Hyperlipidemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to examine benefits of Pemafibrate in medical practitioner : special focus on the effet among alcohol-dependent
Hyperlipidemia patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical laboratory data of triglyceride and high density lipoprotein-cholesterol post 24months treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hyperlipidemia patients treted with Pemafibrate
Key exclusion criteria
1)Hypersensitivity for Pemafibrate
2)High LDL-C alone
3)Severe liver damage liver cirrhosis or bile duct ofstraction
4)Renal dysfunction more than grade3
5)Cholelithiasis
6)Pregnancy
7)Under medication with cyclosporine or rifampicin
8)Judged as inappropriate patient
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Urata |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Cardiovascular Diseases
Zip code
818-8502
Address
1-1-1,Zokumyoin,Chikushino Fukuoka 818-8502 Japan
TEL
092-925-4007
uratah@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Urata |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Cardiovascular Diseases
Zip code
818-8502
Address
1-1-1,Zokumyoin,Chikushino Fukuoka 818-8502 Japan
TEL
092-925-4007
Homepage URL
uratah@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Kowa Company.Ltd.
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
Fukuoka University-Medical Ethics Review Board
Address
7-45-1,Nanakuma,Fukuoka Fukuoka 814-0180 Japan
Tel
092-801-1011
fumed-ethics@fukuoka-u.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
| 2020 | Year | 09 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
202
Results
In an analysis of 176 patients who could be followed up to 24 weeks by oral administration of Pemafibrate, triglyceride level(TG) significantly decreased (-50%). In the alcohol drinkers who were the focus of this study, the Pemafibrate pre-administration value was significantly higher (+22%) compared to the non-drinkers. After taking Pemafibrate, TG decreased significantly in all alcohol categories.
Results date posted
| 2023 | Year | 05 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Higher level of serum triglycerides (serum TG level >150 mg/dL)
Participant flow
Adverse events
none
Outcome measures
Efficacy of Pemafibrate as primary endpoints, TG (fasting or ad libitum), HDL-cholesterol, AST, ALT, gamma-GTP, ALP, amylase, drinking history, amount of alcohol, and safety, incidence of side effects (events, degree, incidence rate, etc.). As secondary endpoints, physical findings, height (baseline only), weight, blood pressure, heart rate, blood test, BUN, serum creatinine, eGFR, total cholesterol, LDL-cholesterol (direct method, calculation formula), CK, blood sugar, HbA1c, uric acid, red blood cell count, white blood cell count, platelet count, hematocrit, hemoglobin , Na, K, Cl, urinalysis qualitative (protein, sugar, occult blood, ketone bodies).
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter non-blinded prospective observational study
Retrospective registration by clinical practitioner for hypertriglyceride patients treated with Pemafibrate
Measured items: age, sex, height, weight, past- & present-history, alcoholic behavior, smoking, medication, general biochemical blood and urine data
Management information
Registered date
| 2020 | Year | 09 | Month | 18 | Day |
Last modified on
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047747
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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