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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002011
Receipt No. 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

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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
Email

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
Email ohkusa@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine, Kashiwa Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002449

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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