UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012267 |
|---|---|
| Receipt number | R000014343 |
| Scientific Title | Prospective, randomized, open-label, clinical trial comparing the effects of bezafibrate and ethyl icosapentate/docosahexaenoate combination on progression of atherosclerotic plaques, endothelial function and markers for inflammation |
| Date of disclosure of the study information | 2013/11/12 |
| Last modified on | 2018/05/24 14:22:10 |
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Basic information
Public title
Prospective, randomized, open-label, clinical trial comparing the effects of bezafibrate and ethyl icosapentate/docosahexaenoate combination on progression of atherosclerotic plaques, endothelial function and markers for inflammation
Acronym
Prospective, randomized, open-label, clinical trial comparing the effects of bezafibrate and ethyl icosapentate/docosahexaenoate combination
Scientific Title
Prospective, randomized, open-label, clinical trial comparing the effects of bezafibrate and ethyl icosapentate/docosahexaenoate combination on progression of atherosclerotic plaques, endothelial function and markers for inflammation
Scientific Title:Acronym
Prospective, randomized, open-label, clinical trial comparing the effects of bezafibrate and ethyl icosapentate/docosahexaenoate combination
Region
| Japan |
Condition
Condition
dyslipidemia
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of bezafibrate and ethyl icosapentate/docosahexaenoate combination on progression of atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI), 12/24 months after randomization
Key secondary outcomes
Serum lipids (total/LDL/HDL-cholesterol, triglycerides), 6/12/24 months after randomization.
Flow-mediated vasodilation in forearm, 6 months after randomization
Heparin-releasable EC-SOD levels, 6 months after randomization
Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria), 6/12/24 months after randomization.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is 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 bezafibrate
Interventions/Control_2
Administration of ethyl icosapentate/docosahexaenoate combination
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects with fasting serum triglycerides levels>150mg/dL, or HDL-C levels<40/50 mg/dl (male/female) or remnant like particle cholesterol levels>7.6
2) Subjects with aortic atherosclerotic plaques detected by MRI.
3) Outpatients
4) Subjects who gave written informed consent
Key exclusion criteria
1) Allergy against bezafibrate or ethyl icosapentate/docosahexaenoate
2) Poor controlled diabetes mellitus (HbA1c>10%)
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 exceeds three-fold of the normal limits.
5) eGFR 30 mL/min/1.73 m2 or less (in case of the subjects treated statins, eGFR 60 mL/min/1.73 m2 or less)
6) Symptomatic (NYHA III or IV) congestive heart failure
7) Malignancies or other diseases with poor prognosis
8) Pregnant
9) Severe infection/trauma
10) Subjects who statins treatment is recommended by Guideline of Japan Atherosclerotic Society 2012.
11) Subjects whose doctor in charge do not agree to join the trial
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsunori Ikewaki |
Organization
National Defense Medical College
Division name
Department of Internal Medicine
Zip code
Address
3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL
04-2995-1617
katsunorike@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Ayaori |
Organization
National Defense Medical College
Division name
Department of Internal Medicine
Zip code
Address
3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL
04-2995-1617
Homepage URL
ayaori@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
Address
Tel
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
| 2013 | Year | 11 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 11 | Day |
Last modified on
| 2018 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014343
