UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019287 |
|---|---|
| Receipt number | R000022298 |
| Scientific Title | Antihypertensive therapy of bevacizumab-induced hypertension. |
| Date of disclosure of the study information | 2015/10/08 |
| Last modified on | 2019/01/18 08:51:48 |
* 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
Antihypertensive therapy of bevacizumab-induced hypertension.
Acronym
Antihypertensive therapy of bevacizumab-induced hypertension.
Scientific Title
Antihypertensive therapy of bevacizumab-induced hypertension.
Scientific Title:Acronym
Antihypertensive therapy of bevacizumab-induced hypertension.
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hypotensive effect of antihypertensive agent for bevacizumab induced hypertension is unclear. This study aimed to describe the efficacy of antihypertensive agent for Bevacizumab-induced hypertension in cancer patients treated with Bevacizumab.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is home blood pressure control ratio at three weeks after initiation of treatment with an antihypertensive agent.
Key secondary outcomes
The secondary endpoint is
1)Change of the home blood pressure due to treatment with antihypertensive agent for Bevacizumab-induced hypertension.
2)Change of the office blood pressure due to treatment with antihypertensive agent for Bevacizumab-induced hypertension.
3)adverse event due to treatment with antihypertensive agent for Bevacizumab-induced hypertension.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Pathologically confirmation of cancer.
2)Administration of bevacizumab (15mg/kg) is planned.
3)No prior therapy of anti-VEGF antibody drug.
4)No prior therapy of antihypertensive drug.
5)Written informed consent.
Key exclusion criteria
1)Renal failure (Cre>=1.5mg/dL)
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Iida |
Organization
Shizuoka Cancer Center
Division name
Division of Cardiology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL
(+81)055-989-5222
k.iida@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Oyakawa |
Organization
Shizuoka Cancer Center
Division name
Division of Cardiology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL
(+81)055-989-5222
Homepage URL
t.oyakawa@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Cancer Center
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
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
| 2015 | Year | 10 | Month | 08 | 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
| 2015 | Year | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
We monitor the home and office blood pressure of the patients receiving Bevacizumab. When patients develop Bevacizumab-induced hypertension, we initiate treatment with an antihypertensive drug.
Management information
Registered date
| 2015 | Year | 10 | Month | 08 | Day |
Last modified on
| 2019 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022298
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
