UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003055 |
|---|---|
| Receipt number | R000003707 |
| Scientific Title | Effectiveness of Ezetimibe or Pitavastatin calcium calcium in NASH/NAFLD patients with high cholesterol levels: a randomized controlled study |
| Date of disclosure of the study information | 2010/01/18 |
| Last modified on | 2013/08/30 19:03:34 |
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Basic information
Public title
Effectiveness of Ezetimibe or Pitavastatin calcium calcium in NASH/NAFLD patients with high cholesterol levels: a randomized controlled study
Acronym
Effectiveness of Ezetimibe or Pitavastatin calcium calcium in NASH/NAFLD patientslevels: a randomized controlled study
Scientific Title
Effectiveness of Ezetimibe or Pitavastatin calcium calcium in NASH/NAFLD patients with high cholesterol levels: a randomized controlled study
Scientific Title:Acronym
Effectiveness of Ezetimibe or Pitavastatin calcium calcium in NASH/NAFLD patientslevels: a randomized controlled study
Region
| Japan |
Condition
Condition
The NASH/NAFLD patients with high cholesterol level
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effectiveness on cholesterol level and safety of Ezetimibe or Pitavastatin calcium, and on the improvement of liver dysfunction in NASH/NAFLD patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The level of alanine aminotransferase
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pitavastatin calcium
Interventions/Control_2
Ezetimibe
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
1)The patients with fatty liver
2)The patients with the level of ALT (42-120IU/L)
3)The patients with high cholesterol levels
Key exclusion criteria
1)The patients with the use of drugs for dyslipidemia within 4 weeks
2)The patients with chronic kidney disease (serum Cre>2.0) or severe liver dysfunction
3)The patients who are pregnant or giving the breast to a baby or want to be pregnat within the period of trial.
4)The patients with cyclosporin
5)The patients with liver dysfunction by drug, alchol, virus, or autoimmnue factors.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Yokosuka |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Medicine and Clinical Oncology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Japan
TEL
043-226-2083
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumio Imazeki |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Medicine and Clinical Oncology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba City, JAPAN
TEL
043-226-2083
Homepage URL
imazekif@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2010 | Year | 01 | Month | 18 | 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
| 2009 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
| 2010 | Year | 01 | Month | 18 | Day |
Last modified on
| 2013 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003707
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
