UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046474 |
|---|---|
| Receipt number | R000053027 |
| Scientific Title | A prospective observational study for the impact of pemafibrate on cardio-ankle vascular index (CAVI) |
| Date of disclosure of the study information | 2022/01/04 |
| Last modified on | 2024/06/27 16:11:07 |
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Basic information
Public title
A prospective observational study for the impact of pemafibrate on cardio-ankle vascular index (CAVI)
Acronym
PEMA-CAVI
Scientific Title
A prospective observational study for the impact of pemafibrate on cardio-ankle vascular index (CAVI)
Scientific Title:Acronym
PEMA-CAVI
Region
| Japan |
Condition
Condition
hypertriglyceridemia
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe change in CAVI in patients with hypertriglyceridemia who are regular outpatients receiving pemafibrate and have a history of type 2 diabetes (mellitus) or ischemic heart disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in CAVI after 6 months 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients with hypertriglyceridemia who scheduled to treat with pemafibrate
2) patients with type 2 diabetes or ischemic heart disease
Key exclusion criteria
Patients who are not considered to have sufficient ability to consent or refuse
Minor patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsuhito |
| Middle name | |
| Last name | Saiki |
Organization
Toho University, Sakura Medical Center
Division name
Center of Diabetes, Endocrinology and Metabolism
Zip code
285-8741
Address
564-1, Shimoshizu, Sakura City, Chiba
TEL
043-462-8811
atsuhito156@sakura.med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhito |
| Middle name | |
| Last name | Saiki |
Organization
Toho University, Sakura Medical Center
Division name
Center of Diabetes, Endocrinology and Metabolism
Zip code
285-8741
Address
564-1, Shimoshizu, Sakura City, Chiba
TEL
043-462-8811
Homepage URL
atsuhito156@sakura.med.toho-u.ac.jp
Sponsor or person
Institute
Toho University, Sakura Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kowa company, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Toho University, Sakura Medical Center
Address
564-1, Shimoshizu, Sakura City, Chiba
Tel
043-462-8811
sakura.rinri@ext.toho-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
東邦大学医療センター佐倉病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 04 | 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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Monocenter, prospective observational study
items: CAVI, age, sex, height, weight, medical history, medication, general biochemical blood and urine data etc.
Management information
Registered date
| 2021 | Year | 12 | Month | 25 | Day |
Last modified on
| 2024 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053027
