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
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
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
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
