UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001587 |
|---|---|
| Receipt number | 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 12:23:45 |
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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
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
Sponsor or person
Institute
Yokohama City University Hospital
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001825
