UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041139 |
|---|---|
| Receipt number | R000046065 |
| Scientific Title | Prospective, randomized, open-label, clinical trial comparing the effects of pemafibrate and ethyl icosapentate on glucose/lipids metabolism and endothelial function in patients with hyperlipidemia |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2022/10/21 11:42:50 |
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Basic information
Public title
Prospective, randomized, open-label, clinical trial comparing the effects of pemafibrate and ethyl icosapentate on glucose/lipids metabolism and endothelial function in patients with hyperlipidemia
Acronym
Effects of pemafibrate and ethyl icosapentate on endothelial function
Scientific Title
Prospective, randomized, open-label, clinical trial comparing the effects of pemafibrate and ethyl icosapentate on glucose/lipids metabolism and endothelial function in patients with hyperlipidemia
Scientific Title:Acronym
Effects of pemafibrate and ethyl icosapentate on endothelial function
Region
| Japan |
Condition
Condition
Hyperlipidemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of pemafibrate versus ethyl icosapentate on glucose/lipids metabolism and endothelial function in patients with hyperlipidemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Flow-mediated vasodilation in forearm
Six weeks after administration
Key secondary outcomes
Hemoglobin A1C levels, glycoalbumin levels, fasting blood glucose, lipids levels, HDL function, markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria/L-FABP)
Six weeks after administration
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of pemafibrate first, then change to ethyl icosapentate
Interventions/Control_2
Administration of ethyl icosapentate first, then change to pemafibrate
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Hypertriglycemia patients whose fasting blood triglyceride levels greater than 150mg/dl.
2) Outpatients
3) Subjects who gave written informed consent
Key exclusion criteria
1) Allergy against pemafibrate/ethyl icosapentate
2) Poor-controlled diabetes (HbA1c>10.0 %)
3) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
4) Either level of aspartate aminotransaminase or alanine aminotransferase exceed three-fold of the normal limits
5) End stage renal failure
6) Symptomatic (NYHA III or IV) congestive heart failure
7) Malignancies or other diseases with poor prognosis
8) Pregnant
9) Subjects whose doctor in charge do not agree to join the trial
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Sasaki |
Organization
National Defense Medical College
Division name
Division of Anti-aging and Vascular Medicine, Department of Internal Medicine,
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa, Japan
TEL
0429951211
con301@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Sasaki |
Organization
National Defense Medical College
Division name
Division of Anti-aging and Vascular Medicine, Department of Internal Medicine,
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa, Japan
TEL
0429951211
Homepage URL
con301@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College IRB
Address
3-2 Namiki, Tokorozawa, Japan
Tel
04-2995-1211
rinri@ndmc.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 | 08 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 15 | 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
Management information
Registered date
| 2020 | Year | 07 | Month | 17 | Day |
Last modified on
| 2022 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046065
