UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012656 |
|---|---|
| Receipt number | R000014801 |
| Scientific Title | clinical outcomes of Azilsartan, angiotensin receptor blocker on castration-resistant prostate cancer |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2018/07/10 18:30:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
clinical outcomes of Azilsartan, angiotensin receptor blocker on castration-resistant prostate cancer
Acronym
Effect of Azilsartan on castration-resistant prostate cancer
Scientific Title
clinical outcomes of Azilsartan, angiotensin receptor blocker on castration-resistant prostate cancer
Scientific Title:Acronym
Effect of Azilsartan on castration-resistant prostate cancer
Region
| Japan |
Condition
Condition
castration-resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of Azilsartan, angiotensin receptor blocker, on castration-resistant prostate cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change in the prostate specific antigen
Key secondary outcomes
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
1.20mg of Azilsartan is administered after enrollment of the study. The dose can be increased to the 40mg to some patients.
2. After 8 weeks administration, changes in the prostate specific antigen and performance status will be evaluated.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients with castration-resitant prostate cancer
Key exclusion criteria
1. allergic to Azilsartan
2. angiotensin receptor blocker has been already prescribed
3. informed consent has not been obtained
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruyuki Ogawa |
Organization
Shinshu University School of Medicine
Division name
Department of Urology
Zip code
Address
3-1-1 Asahi Matsumoto, Nagano
TEL
0263-37-2661
ogawat@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruyuki Ogawa |
Organization
Shinshu University School of Medicine
Division name
Department of Urology
Zip code
Address
3-1-1 Asahi Matsumoto, Nagano
TEL
0263-37-2661
Homepage URL
ogawat@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2014 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 12 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | 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
| 2013 | Year | 12 | Month | 23 | Day |
Last modified on
| 2018 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014801
