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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041139
Receipt No. 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 2020/07/17

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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
Email 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
Email con301@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

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
Email 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 Preinitiation
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
2020 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046065

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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