NIPH Clinical Trials Search

UMIN ID: UMIN000001587

Registered date:25/12/2008

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.

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedNon-alcoholic steatohepatitis
Date of first enrollment2008/12/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)administration of olmesartan (40mg daily) in 24 weeks. administration of telmisartan (40mg daily) in 24 weeks. administration of amlodipine (7.5mg daily) in 24 weeks.


Primary OutcomeBefore 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.
Secondary OutcomeTo measure the factors about NASH progressive marker as glucose and lipid metabolite, oxidative stress, visceral/subcutaneous fat area,liver TG content.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1)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.

Related Information


public contact
Address Japan
Telephone 045-787-2800
Affiliation Yokohama-city university hospital Division of Gastroenterology
scientific contact
Name Koji Fujita
Address 3-9,fukuura,kanazawa-ku,yokohama,kanagawa,Japan Japan
Telephone 045-787-2640
Affiliation Yokohama-city university hospital Division of Gastroenterology