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
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
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
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
