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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010940
Receipt No. R000012806
Scientific Title The comparison of azilsartan and amlodipine for treatment of VEGF receptor-tyrosine kinase inhibitor-induced hypertension in advanced kidney cancer patients
Date of disclosure of the study information 2013/06/12
Last modified on 2018/06/18

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Basic information
Public title The comparison of azilsartan and amlodipine for treatment of VEGF receptor-tyrosine kinase inhibitor-induced hypertension in advanced kidney cancer patients
Acronym The comparison of azilsartan and amlodipine for treatment of VEGFR-TKI-induced hypertension
Scientific Title The comparison of azilsartan and amlodipine for treatment of VEGF receptor-tyrosine kinase inhibitor-induced hypertension in advanced kidney cancer patients
Scientific Title:Acronym The comparison of azilsartan and amlodipine for treatment of VEGFR-TKI-induced hypertension
Region
Japan

Condition
Condition VEGFR-TKI-induced hypertension
Classification by specialty
Hematology and clinical oncology Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Vascular endothelial growth factor receptor tyrosin kinase inhibitors (VEGFR-TKI) have high incidence of hypertension as an adverse event, and this hypertension becomes a critical factor of discontinuation of VEGFR-TKI. Therefore, the control of hypertension is very important for continuation of VEGFR-TKI and to achieve the best outcome in kidney cancer treatment. In this study, we will compare the efficacy of azilsartan and amlodipine as a treatment for VEGFR-TKI-induced hyprtension.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The comparison of the efficacy between azilsartan group and amlodipine group
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is 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 Azilsartan
Interventions/Control_2 amlodipine
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 diagnosed as cancer or sarcoma
2. no aplication for radical treatment because of locally advanced or metastatic disease
3. patients know their diagnosis and status
4. undergoing VEGFR-TKI treatment
5. without hypertension at the start of VEGFR-TKI
6. without anti-hypertensive at the start of VEGFR-TKI
7. newly arisen hypertension (systolic >140mmHg and increase 20mmHg starting VEGFR-TKI compared with before VEGFR-TKI treatment
8. obtained informed concent by document
Key exclusion criteria 1. < 20 year-old
2. Cr>3.0mg/dl or eGFR<15ml/min
3. bilateral renal arterial stenosis or unilateral renal rterial stenosis in solitary kidney
4. allergy to angiotensin 2 receptor blockers or calcium channel blockers
and patients who were thought as inadequate for this study by doctor in charge
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouji Izumi
Organization Kanazawa University
Division name Department of Urology
Zip code
Address 13-1 Takaramachi, Kanazawa
TEL 076-265-2393
Email azuizu2003@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Izumi, Kouji
Organization Kanazawa University
Division name Department of Urology
Zip code
Address 13-1 Takaramachi, Kanazawa, Japan
TEL 076-265-2393
Homepage URL
Email azuizu2003@yahoo.co.jp

Sponsor
Institute Kanazawa University, 13-1 Takaramachi, Kanazawa
Institute
Department

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
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
2013 Year 06 Month 12 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 No longer recruiting
Date of protocol fixation
2013 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 12 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 06 Month 12 Day
Last modified on
2018 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012806

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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