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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012267
Receipt No. 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

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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
Email 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
Email ayaori@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
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014343

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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