UMIN-CTR Clinical Trial
| Recruitment status | Completed |
|---|---|
| Unique ID issued by UMIN | UMIN000012557 |
| Receipt number | R000011911 |
| Scientific Title | Effect of bezafibrate on endothelial dysfunction induced by postprandial hypelipidemia |
| Date of disclosure of the study information | 2013/12/12 |
| Last modified on | 2013/12/12 |
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Basic information
Public title
Effect of bezafibrate on endothelial dysfunction induced by postprandial hypelipidemia
Acronym
Effect of bezafibrate on endothelial dysfunction induced by postprandial hypelipidemia
Scientific Title
Effect of bezafibrate on endothelial dysfunction induced by postprandial hypelipidemia
Scientific Title:Acronym
Effect of bezafibrate on endothelial dysfunction induced by postprandial hypelipidemia
Region
| Japan |
Condition
Condition
patients with metabolic syndrome
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of bezafibrate on postprandial hyperlipidemia and its induced endothelial dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in FMD during postprandial state at baseline and after bezafibrate treatment
Key secondary outcomes
In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
orally bezafibrate treatment
Interventions/Control_2
No treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients wiht metabolic syndrome
2)Subjects who obtained written-informed consent for study participation
Key exclusion criteria
Patients treated with hypoglycemic agents and/or lipid-lowering agents
Patients having allergy for research reagents
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Miyoshi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-5-1 Shikata-cho Okayama
TEL
086-235-7351
miyoshit@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Miyoshi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-5-1 Shikata-cho Okayama
TEL
086-235-7351
Homepage URL
miyoshit@cc.okayama-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean "funding agency". Therefore, all clinical trial should have the one.
Funding Source
Organization
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Other
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 | 12 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | 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 | 12 | Month | 12 | Day |
Last modified on
| 2013 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011911
