UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020537 |
|---|---|
| Receipt number | R000023715 |
| Scientific Title | Therapeutic efficacy and safety of telmisartan in patients with non-alcoholic fatty liver disease (NAFLD) and hypertension: exploratory research |
| Date of disclosure of the study information | 2016/01/12 |
| Last modified on | 2016/01/12 20:49:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Therapeutic efficacy and safety of telmisartan in patients with non-alcoholic fatty liver disease (NAFLD) and hypertension: exploratory research
Acronym
Efficacy and safety of telmisartan in patients with NAFLD and hypertension
Scientific Title
Therapeutic efficacy and safety of telmisartan in patients with non-alcoholic fatty liver disease (NAFLD) and hypertension: exploratory research
Scientific Title:Acronym
Efficacy and safety of telmisartan in patients with NAFLD and hypertension
Region
| Japan |
Condition
Condition
Non-alcoholic fatty liver disease and hypertension
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of telmisartan for liver dysfunction in patients with non-alcoholic fatty liver disease and hypertension.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in the value of liver fibrosis marker between baseline and after 12 months of treatment
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
telmisartan (20 to 80 mg daily)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) ALT >= 30 IU/L without excess alcohol consumption
(2) Controlled attenuation parameter (CAP)>= 250 dB/m
(3) Clinic blood pressure >= 130/85 mmHg
(4) Written informed consent
Key exclusion criteria
(1) Treatment histody of ARB, ACE inhibitor, renin inhibitor, or thiazolidine
(2) History of hepatic disease, such as chronic hepatitis C or concurrent active hepatitis B (serum positive for hepatitis B surface antigen), autoimmune hepatitis, or primary biliary cirrhosis (PBC)
(3) Secondary hypertension
(4) History of allergy for telmisartan
(5) Pregnancy or lactation in women
(6) Inadequacy for this therapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Furusyo |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5909
furusyo@gim.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motohiro Shimizu |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5909
Homepage URL
smotohir@gim.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of General Internal Medicine, Kyushu 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
| 2016 | Year | 01 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | 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
| 2016 | Year | 01 | Month | 12 | Day |
Last modified on
| 2016 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023715
