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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026984
Receipt No. R000026406
Scientific Title Investigation for the effect of anti-dyslipidemic drugs on serum level of trans-fatty acids
Date of disclosure of the study information 2018/03/31
Last modified on 2018/04/16

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Basic information
Public title Investigation for the effect of anti-dyslipidemic drugs on serum level of trans-fatty acids
Acronym Trans-fat level-reducing drug study
Scientific Title Investigation for the effect of anti-dyslipidemic drugs on serum level of trans-fatty acids
Scientific Title:Acronym Trans-fat level-reducing drug study
Region
Japan

Condition
Condition dyslipidemia
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Serum level of trans-fatty acids has been reported to be a risk factor for coronary artery disease in Japan. However, it remains unclear whether the serum trans-fatty acid level is modulated by medical treatment. The present study aimed to clarify the effect of anti-dyslipidmic drugs on serum level of trans-fatty acids.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum trans-fatty acid concentration and lipid profile after 2 weeks of anti-dyslipidemic drugs.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Purified EPA 1800mg/day 14 days
Interventions/Control_2 ezetimibe 10mg/day 14 days
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 Healthy volunteer
Key exclusion criteria 1. Lack of informed consent
2. Pregnancy
3. Allergy against ezetimibe or EPA
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuro Ishida
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL 078-382-5846
Email ishida@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuro Ishida
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL 078-382-5846
Homepage URL
Email ishida@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 03 Month 31 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
2016 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
2017 Year 05 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
2017 Year 04 Month 13 Day
Last modified on
2018 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026406

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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