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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003975
Receipt No. R000004717
Scientific Title Randomized Controlled Trial of Olmesartan Medoxomil Administration in the Prevention of Hepatic Fibrosis in the selected Patients with Cirrhosis
Date of disclosure of the study information 2010/08/01
Last modified on 2010/07/17

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Basic information
Public title Randomized Controlled Trial of Olmesartan Medoxomil Administration in the Prevention of Hepatic Fibrosis in the selected Patients with Cirrhosis
Acronym Efficacy of Olmesartan in the Prevention of Hepatic Fibrosis
Scientific Title Randomized Controlled Trial of Olmesartan Medoxomil Administration in the Prevention of Hepatic Fibrosis in the selected Patients with Cirrhosis
Scientific Title:Acronym Efficacy of Olmesartan in the Prevention of Hepatic Fibrosis
Region
Japan

Condition
Condition Liver Cirrhosis, Child A or B
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the long-term effects of olmesartan, an angiotensin type 1 (AT1) receptor blocker, on hemodynamic and on liver fibrosis.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The primary endpoint is the rate of patients showing reduction in HVPG of more than 20% of baseline values after a year.
Key secondary outcomes The secondary endpoint is the rate of patients showing reduction in blood markers of hepatic fibrosis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Olmesartan Medoxomil
Interventions/Control_2 Control
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) age between 18 and 75 years; (2) proven liver cirrhosis with a diagnosis based on histology or unequivocal clinical, sonographic, and laboratory findings; (3) alcoholic etiology of cirrhosis had to have refused taking alcohol for >=3 months before the start of the study; (4) Child-Pugh score >=9; and (5) absent or small esophageal varices.
Key exclusion criteria (1) mean arterial pressure <60 mmHg; (2) ARB intolerance; (3) current treatment with ARB, angiotensin-converting enzyme inhibitors, or beta-blockers; (4) hypertrophic cardiomyopathy or renal arterial stenosis; (5) serum creatinine >1.6 mg/dL; (6) hyperkalemia defined as plasma potassium >5.5 meq/L; (7) hepatocellular carcinoma; and (8) portal thrombosis. Current treatment with diuretics was allowed and not changed during the study period.
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Hidaka
Organization Kitasato University East Hospital
Division name Department of Gastroenterology, Internal Medicine
Zip code
Address 2-1-1 Asamizodai, Minami-ku, Sagamihara, Kanagawa
TEL 042-748-9111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Hidaka
Organization Kitasato University East Hospital
Division name Department of Gastroenterology, Internal Medicine
Zip code
Address 2-1-1 Asamizodai, Minami-ku, Sagamihara, Kanagawa
TEL
Homepage URL
Email

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Kitasato University
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 北里大学東病院

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 01 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 Completed
Date of protocol fixation
2007 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2010 Year 06 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
2010 Year 08 Month 01 Day
Last modified on
2010 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004717

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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