UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000756 |
|---|---|
| Receipt number | R000000908 |
| Scientific Title | Candesartan may prevent aneurysmal changes in the residual native aorta after thoracic aortic aneurysm surgery |
| Date of disclosure of the study information | 2007/07/01 |
| Last modified on | 2018/12/05 17:24:20 |
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Basic information
Public title
Candesartan may prevent aneurysmal changes in the residual native aorta after thoracic aortic aneurysm surgery
Acronym
CAPTAIN Study
Scientific Title
Candesartan may prevent aneurysmal changes in the residual native aorta after thoracic aortic aneurysm surgery
Scientific Title:Acronym
CAPTAIN Study
Region
| Japan |
Condition
Condition
Thoracic aortic aneurysm
Classification by specialty
| Cardiology | Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether or not angiotensin receptor blocker can exert a role to prevent aneurysmal changes in the residual aorta after thoracic aortic surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the aortic diameter
Key secondary outcomes
Pulse wave velocity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Cnadesartan
Interventions/Control_2
Administration of antihypertensive drug other than Candesartan
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
Patients with hypertention who underwent thoracic aortic surgery
Key exclusion criteria
Patients with contraindication for Candesartan
Patients with allergic reaction to Candesartan
Pregnant or potentially pregnant
Patients who did not consent to the study
Patients under 20 years of age
Others who are not suitable to the enrollment from the physician's point of view
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Tabayashi |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Cardiovascular Surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-7222
konosuke.s@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikatsu Saiki |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Cardiovascular Surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-7222
Homepage URL
ysaiki@mail.tains.tohoku.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2007 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2007 | 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
| 2007 | Year | 06 | Month | 28 | Day |
Last modified on
| 2018 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000908
