UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004156
Receipt number R000004991
Scientific Title A prospective analysis of the effect of statins on postprandial serum triglyceride level
Date of disclosure of the study information 2010/09/06
Last modified on 2016/03/05 12:42:37

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Basic information

Public title

A prospective analysis of the effect of statins on postprandial serum triglyceride level

Acronym

Effect of statins on postprandial serum triglyceride level

Scientific Title

A prospective analysis of the effect of statins on postprandial serum triglyceride level

Scientific Title:Acronym

Effect of statins on postprandial serum triglyceride level

Region

Japan


Condition

Condition

Dyslipidemia

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study is aimed to evaluate the effect of statins on serum triglyceride, and to analyze the mechanisms of it's anti-atherosclerotic effect and inhibitory effect on cardiovascular events.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Fasting and postprandial level of serum HDL, LDL, and triglyceride 4 to 8 weeks after statin administration.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We administer rosuvastatin 5mg or pisuvastain 2mg daily to patients with dyslipidemia that could not be improved with 8-week dietary practice.

Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Eligible patients are those with dyslipidemia based on the diagnostic guideline of dyslipidemia of Japan Atherosclerosis Society, and that could not be improved with 8-week dietary practice.

Key exclusion criteria

Patients with thyroid disorders, nephrotic syndrome, cirrhosis, hemodialysis, and who have taken drugs for dyslipidemia.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiharu Fujimori

Organization

Suwa Central Hospital

Division name

Department of Cardiology

Zip code


Address

Tamagawa4300, Chino city, Nagano Prefecture

TEL

0266-72-1000

Email

fujimori.yoshiharu@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiharu Fujimori

Organization

Suwa Central Hospital

Division name

Department of Cardiology

Zip code


Address

Tamagawa4300, Chino city, Nagano Prefecture

TEL

0266-72-1000

Homepage URL


Email

fujimori.yoshiharu@gmail.com


Sponsor or person

Institute

Suwa Central Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

諏訪中央病院(長野県)


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 06 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

2010 Year 07 Month 18 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date

2016 Year 03 Month 03 Day

Date of closure to data entry

2016 Year 03 Month 03 Day

Date trial data considered complete

2016 Year 03 Month 03 Day

Date analysis concluded

2016 Year 03 Month 03 Day


Other

Other related information



Management information

Registered date

2010 Year 09 Month 04 Day

Last modified on

2016 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004991


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name