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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019287
Receipt No. 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

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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
Email 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
Email t.oyakawa@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

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
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

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
URL(English) https://upload.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


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