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

Email

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


Email

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


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 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