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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001587
Receipt No. R000001825
Scientific Title Therapeutic efficacy of olmesartan, telmisartan and amlodipine to compare with histologic improvement and addciation about AGTR1 gene polymorphisms in subjects with nonalcoholic steatohepatitis (NASH); randomized open-labeled prospective study.
Date of disclosure of the study information 2008/12/25
Last modified on 2008/12/18

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Basic information
Public title Therapeutic efficacy of olmesartan, telmisartan and amlodipine to compare with histologic improvement and addciation about AGTR1 gene polymorphisms in subjects with nonalcoholic steatohepatitis (NASH); randomized open-labeled prospective study.
Acronym Therapeutic efficacy of olmesartan, telmisartan and amlodipine in subjects with nonalcoholic steatohepatitis (NASH)
Scientific Title Therapeutic efficacy of olmesartan, telmisartan and amlodipine to compare with histologic improvement and addciation about AGTR1 gene polymorphisms in subjects with nonalcoholic steatohepatitis (NASH); randomized open-labeled prospective study.
Scientific Title:Acronym Therapeutic efficacy of olmesartan, telmisartan and amlodipine in subjects with nonalcoholic steatohepatitis (NASH)
Region
Japan

Condition
Condition Non-alcoholic steatohepatitis
Classification by specialty
Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the efficacy of ARB and Ca-blocker to compare about liver lipid-metabolite alteration with histologic improvement in subjects with nonalcoholic steatohepatitis; check with AGTR1 gene polymorphism.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Before and after 6 months of medication to nonalcoholic statohepatitis (NASH) patients, we assessed liver lipid-metabolite alteration for use minute lipid analyzer: LipoSEARCH, hepatic histologic features,and AGTR1 gene polymorphisms.
Key secondary outcomes To measure the factors about NASH progressive marker as glucose and lipid metabolite, oxidative stress, visceral/subcutaneous fat area,liver TG content.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of olmesartan (40mg daily) in 24 weeks.
Interventions/Control_2 administration of telmisartan (40mg daily) in 24 weeks.
Interventions/Control_3 administration of amlodipine (7.5mg daily) in 24 weeks.
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 a.All patients complicate hypertension (sBP 140-179mmHg, dBP 90-109mmHg )

b.The biopsy-proven nonalcoholic steatosis(NASH) patient will be evaluated in this study.

c. All patients gave their written informed consent to participation in the study.
Key exclusion criteria 1)The patient with diabetes mellitus(HbA1c>6.2)
2) contraction of renal artery.
3) The criteria for exclusion from participation in the study: history of hepatic disease, such as chronic hepatitis C or concurrent active hepatitis B (serum positive for hepatitis B surface antigen), autoimmune hepatitis, primary biliary cirrhosis (PBC), sclerosing cholangitis, hemochromatosis, wilsons disease, and current or past consumption of more than 20g of alcohol daily.
4) an anamnesis of drug allergy to use.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Fujita
Organization Yokohama-city university hospital
Division name Division of Gastroenterology
Zip code
Address 3-9,fukuura,kanazawa-ku,yokohama,kanagawa,Japan
TEL 045-787-2640
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yokohama-city university hospital
Division name Division of Gastroenterology
Zip code
Address
TEL 045-787-2800
Homepage URL
Email

Sponsor
Institute Yokohama City University Hospital
Institute
Department

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
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
2008 Year 12 Month 25 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
Date of protocol fixation
2008 Year 11 Month 19 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 12 Month 18 Day
Last modified on
2008 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001825

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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