UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002011 |
|---|---|
| Receipt number | R000002449 |
| Scientific Title | Efficacy and safety of statin treatment for hypercholesterolemia with chronic liver disease |
| Date of disclosure of the study information | 2009/05/27 |
| Last modified on | 2012/11/29 22:53:40 |
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Basic information
Public title
Efficacy and safety of statin treatment for hypercholesterolemia with chronic liver disease
Acronym
Efficacy and safety of statin treatment for hypercholesterolemia with chronic liver disease
Scientific Title
Efficacy and safety of statin treatment for hypercholesterolemia with chronic liver disease
Scientific Title:Acronym
Efficacy and safety of statin treatment for hypercholesterolemia with chronic liver disease
Region
| Japan |
Condition
Condition
chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of the long-term treatment of pitavastatin for hypercholesterolemia with chronic liver disease through blood examination and diagnostic imaging.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Change in AST, ALT, gammaGTP, ALP(for NAFLD, NASH)
2.Change in HCV RNA(for hepatitis C)
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
Pitavastatin 1-2mg/day
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Hypercholesterolemia
(2)Chronic liver disease(NAFLD/NASH, hepatitis C)
(3)Age 20 to 74
(4)Patients who received sufficient explanation and agreed with written informed consent
Key exclusion criteria
(1)Contraindication or relative contraindication of pitavastatin calcium.
-Hypersensitivity for pitavastatin calcium
-Serious hepatic disorder or biliary atresia
-Receiving ciclosporin
-Pregnant women, women suspected of being pregnant, or lactating women
-Patients receiving fibrates who have abnormal laboratory test values about renal function
(2)Women hoping to become pregnant during the study
(3)Drug abuse, alcoholism
(4)Patients judged to be inappropriate by the attending doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshifumi Ohkusa |
Organization
The Jikei University School of Medicine, Kashiwa Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
163-1 kashiwashita, Kashiwa, Chiba 277-8567, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshifumi Ohkusa |
Organization
The Jikei University School of Medicine, Kashiwa Hospital
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
163-1 kashiwashita, Kashiwa, Chiba 277-8567, Japan
TEL
04-7164-1111
Homepage URL
ohkusa@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine, Kashiwa Hospital
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine, Kashiwa Hospital
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
| 2009 | Year | 05 | Month | 27 | 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
The cases did not meet only 10 patients, the study was discontinued.
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
Terminated
Date of protocol fixation
| 2009 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 11 | Month | 29 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 26 | Day |
Last modified on
| 2012 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002449
