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

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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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name