UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003377 |
|---|---|
| Receipt number | 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 | 2024/04/08 18:17:37 |
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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
Blood pressure
Inflammatory markers in the blood
Lipid abnormality evaluation
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 | Yoshikatsu |
| Middle name | |
| Last name | Saiki |
Organization
Tohoku university hospital
Division name
Cardiovascular surgery
Zip code
9808574
Address
Seiryocho 1-1,Aobaku,Sendai,Miyagi
TEL
022-717-7222
yoshisaiki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yoshikatsu |
| Middle name | |
| Last name | Saiki |
Organization
Tohoku university hospital
Division name
Cardiovascular surgery
Zip code
9808574
Address
Seiryocho 1-1,Aobaku,Sendai,Miyagi
TEL
022-717-7222
Homepage URL
yoshisaiki@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university hospital cardiovascular surgery
Institute
Department
Personal name
Yoshikatsu Saiki
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
Seiryocho 2-1,Aobaku,Sendai,Miyagi
Tel
022-717-7000
med-kenkyo@bureau.tohoku.ac.jp
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
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
28
Results
The trial was canceled due to difficulties in registering for the trial.
Results date posted
| 2024 | Year | 04 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with aortic aneurysm complicated by hypertension
Participant flow
Evaluate on the outpatients
Adverse events
None
Outcome measures
Enlargement of aneurysm diameter
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2009 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2010 | Year | 03 | Month | 25 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004024
