UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005409 |
|---|---|
| Receipt number | R000006400 |
| Scientific Title | Effects of Olmesartan Medoxomil Angiotensin Type 1 (AT1) Receptor Blocker 1 in Selected Patients with Nonalcoholic Steatohepatitis (NASH): Pilot Study |
| Date of disclosure of the study information | 2011/05/01 |
| Last modified on | 2013/02/11 11:26:52 |
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Basic information
Public title
Effects of Olmesartan Medoxomil Angiotensin Type 1 (AT1) Receptor Blocker 1 in Selected Patients with Nonalcoholic Steatohepatitis (NASH): Pilot Study
Acronym
Effects of Olmesartan Medoxomil Angiotensin Type 1 (AT1) Receptor Blocker 1 in Selected Patients with Nonalcoholic Steatohepatitis (NASH): Pilot Study
Scientific Title
Effects of Olmesartan Medoxomil Angiotensin Type 1 (AT1) Receptor Blocker 1 in Selected Patients with Nonalcoholic Steatohepatitis (NASH): Pilot Study
Scientific Title:Acronym
Effects of Olmesartan Medoxomil Angiotensin Type 1 (AT1) Receptor Blocker 1 in Selected Patients with Nonalcoholic Steatohepatitis (NASH): Pilot Study
Region
| Japan |
Condition
Condition
Patients with nonalcoholic steatohepatitis (NASH)
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effects of olmesartan, an angiotensin type 1 (AT1) receptor blocker, on liver fibrosis marker in patients with nonalcoholic steatohepatitis (NASH).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of liver fibrosis marker
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
Olmesartan Medoxomil
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) Proven NASH with a diagnosis based on histology.
(2) Alcoholic etiology of cirrhosis had to have abstained from alcohol for more 3 months before the start of the study.
(3) Child-Pugh score is less than 10.
(4) Absent or small esophageal varices.
Key exclusion criteria
(1)Mean arterial pressure is less than 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 is more than 1.6 mg/dL.
(6)Hyperkalemia defined as plasma potassium more than 5.5 meq/L.
(7)Hepatocellular carcinoma.
(8)Portal venous tumor thrombosis.
Target sample size
22
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 252-0380, Japan
TEL
81-42-748-9111
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
TEL
Homepage URL
hisashi7@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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
| 2011 | Year | 05 | 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
| 2008 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 08 | Day |
Last modified on
| 2013 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006400
