UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000540 |
|---|---|
| Receipt number | R000000639 |
| Scientific Title | Fatty liver protection trial by Telmisartan or Losartan Study |
| Date of disclosure of the study information | 2006/12/10 |
| Last modified on | 2014/02/26 21:03:47 |
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Basic information
Public title
Fatty liver protection trial by Telmisartan or Losartan Study
Acronym
FANTASY study
Scientific Title
Fatty liver protection trial by Telmisartan or Losartan Study
Scientific Title:Acronym
FANTASY study
Region
| Japan |
Condition
Condition
Hypertension with non alcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Angiotensin II Receptor blocker (ARB) on the patients with non alcoholic fatty liver disease (NAFLD).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of liver function (AST, ALT)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Telmisartan
Interventions/Control_2
Losartan
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hypertension (SBP>140 or DBP>90) Non alcoholic fatty liver disease
Key exclusion criteria
Drug allergy for the agents. Severe liver dysfunction. Insulin treatment for diabetes mellistus. Malignancy. Recent major macrovascular disease. Severe hypertension.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihide Kawai |
Organization
Keio University, School of Medicine
Division name
Internal Medicine, Endocrinology Metabolism
Zip code
Address
35 Shinanomachi, Shinjuku-ku,Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University, School of Medicine
Division name
Internal Medicine
Zip code
Address
TEL
03-3353-1211(ext.62383)
Homepage URL
Sponsor or person
Institute
Keio University, School of Medicine, Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio 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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.hindawi.com/journals/ije/2013/587140/
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
| 2006 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 12 | Month | 06 | Day |
Last modified on
| 2014 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000639
