UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009796
Receipt number R000011465
Scientific Title Clinical studies about the organ protection effect in heart and the kidney of telmisartan
Date of disclosure of the study information 2013/01/18
Last modified on 2013/07/25 14:43:04

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Basic information

Public title

Clinical studies about the organ protection effect in heart and the kidney of telmisartan

Acronym

Clinical studies about the organ protection effect in heart and the kidney of telmisartan

Scientific Title

Clinical studies about the organ protection effect in heart and the kidney of telmisartan

Scientific Title:Acronym

Clinical studies about the organ protection effect in heart and the kidney of telmisartan

Region

Japan


Condition

Condition

Ongoing dialysis patients with hypertention.

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the organ protective effect of terumisartan in dialysis patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Effects on cardiac function and vasucular lesions(Echocardiography,Vascular Ultrasound).

Key secondary outcomes

1)ABI,PWV,SPP
2)Blood parameters
CBC:WBC,RBC,PLT
Biochemistry:
CRP,FBS,HbA1c,AST,ALT,ALP,BUN,UA,s-Cr
Others:
Blood inflammation factor


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

Sart with once-daily dosing of 20mg telmisartan,and increase up to 40-80mg,if there is no problem with the tolerability.

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Men or women, age between 20 and 90 years
2)Maintenance dialysis patients
3)Systolic or diastolic pressure >=140/90mmHg
4)Willing and able to provide informed consent

Key exclusion criteria

1))Systolic or diastolic pressure <140/90mmHg
2)Patients with hypersensitivity to this drug
3)Prengnancy and possible pregnancy
4)ALT levels >=500IU/L
5)Patients inadequate for the study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junichi Suzuki

Organization

University of Tokyo,Graduate School of Medicine

Division name

Department of Advanced Clinical Medicine Course

Zip code


Address

7-3-1Hongo,Bunkiyo-ku,Tokyo

TEL

03-5800-9116

Email



Public contact

Name of contact person

1st name
Middle name
Last name Junichi Suzuki

Organization

University of Tokyo,Graduate School of Medicine

Division name

Department of Advanced Clinical Medicine Course

Zip code


Address

7-3-1Hongo,Bunkiyo-ku,Tokyo

TEL

03-5800-9116

Homepage URL


Email



Sponsor or person

Institute

University of Tokyo Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Yokohama Foundation for Advancement of Medical Science
Agency Healthcare Foundation
The Research Foundation for Pharmaceutical Science

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor

Saku Central Hospital,Tokyo Medical and Dental University,Tokyo University

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

佐久総合病院(長野県)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 18 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

2012 Year 05 Month 14 Day

Date of IRB


Anticipated trial start date

2012 Year 09 Month 28 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 17 Day

Last modified on

2013 Year 07 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011465


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name