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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003377
Receipt No. R000004024
Scientific Title Evaluation of the suppressing effect of Telmisarten on aneurysm development in hypertensive aortic aneurysm patients
Date of disclosure of the study information 2010/03/25
Last modified on 2014/03/25

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Basic information
Public title Evaluation of the suppressing effect of Telmisarten on aneurysm development in
hypertensive aortic aneurysm patients
Acronym TELME study
Scientific Title Evaluation of the suppressing effect of Telmisarten on aneurysm development in
hypertensive aortic aneurysm patients
Scientific Title:Acronym TELME study
Region
Japan

Condition
Condition hypertensive aortic aneurysm patients
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the suppressing effect of Telmisarten on aneurysm development in
hypertensive aortic aneurysm patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes aneurysm development
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are 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 Telmisarten
Interventions/Control_2 any other ACE inhibitors and ARB
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 hypertensive aortic aneurysm patients
with ACE inhibitors and ARB
Key exclusion criteria Taboo symptom of Telmisarten
Pregnant women
Liver and renal function failure
Minority

Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikatsu Saiki
Organization Tohoku university hospital
Division name Cardiovascular surgery
Zip code
Address Seiryocho 1-1,Aobaku,Sendai,Miyagi
TEL 022-717-7222
Email yoshisaiki@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshikatsu Saiki
Organization Tohoku university hospital
Division name Cardiovascular surgery
Zip code
Address Seiryocho 1-1,Aobaku,Sendai,Miyagi
TEL 022-717-7222
Homepage URL
Email yoshisaiki@med.tohoku.ac.jp

Sponsor
Institute Tohoku university hospital cardiovascular surgery
Institute
Department

Funding Source
Organization Tohoku university hospital cardiovascular surgery
Organization
Division
Category of Funding Organization Other
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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 25 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
2009 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 03 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
2010 Year 03 Month 25 Day
Last modified on
2014 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004024

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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