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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034880
Receipt No. R000039636
Official scientific title of the study Clinical studies on antihypertensive drugs used for proteinuria and hypertension intended for the bevacizumab-treated patients
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/29

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Basic information
Official scientific title of the study Clinical studies on antihypertensive drugs used for proteinuria and hypertension intended for the bevacizumab-treated patients
Title of the study (Brief title) Study on the effectiveness of antihypertensive drugs on proteinuria and hypertension of bevacizumab-treated patients
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of the ARB and CCB for the bevacizumab-induced proteinuria and hypertension.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of decrease in proteinuria
Key secondary outcomes Rate of decrease in systolic / diastolic blood pressure
Biochemical examination (TP, Alb, AST, ALT, BUN, SCr, T-Bil, Na, K, Cl, Ca)
Urinalysis (uTP, uAlb, uCr, uNa, urinary osmotic pressure)
Serum and urinary ET-1, AT-2, VEGF-A
Adverse event related antihypertensive

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 Oral administration once a day(max 6 month)
Interventions/Control_2 Amlodipine Oral administration once a day(max 6 month)
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients diagnosed with colon cancer by histology or cytology
2) Patients who had metastasis / recurrence in the image confirmed
3) Patients who are receiving bevacizumab
4) Patients diagnosed with hypertension after bevacizumab administration
5) Patients scheduled to be treated by ARB or CCB
6) Patients with ECOG PS 0 to 2
7) Patients of age 20 years or older
8) Scheduled research subjects who received the notification Patients who received written consent from participants to participate in this study
Key exclusion criteria 1) Patients who have continued therapy with bevacizumab for more than 3 months
2) Patients who show proteinuria at least once within 4 weeks before consent acquisition
3) Patients with renal dysfunction of eGFR less than 30 mL / min / 1.73 m 2 at the time of consent acquisition
4) Patients who have taken the following medications before consent acquisition: ARB, angiotensin II converting enzyme inhibitor, direct renin inhibitor, diuretic, CCB, alpha / beta antagonist
5) Patients with diabetes
6) Patients with cardiovascular disorders
7) Patients who may be pregnant or pregnant
8) Patients who are considered difficult to register in this study due to clinically problematic mental illness
Target sample size 70

Research contact person
Name of lead principal investigator Takeshi Chiba
Organization Iwate Medical University, School of Pharmacy
Division name Faculty of clinical pharmacy course
Address 2-1-1, Nishitokuta, Yahaba-cho, Shiwagun, Iwate, Japan
TEL 019-651-5111
Email chibat@iwate-med.ac.jp

Public contact
Name of contact person Haruki Ujiie
Organization Iwate Medical University, School of Pharmacy
Division name Faculty of clinical pharmacy course
Address 2-1-1, Nishitokuta, Yahaba-cho, Shiwagun, Iwate, Japan
TEL 019-651-5111
Homepage URL
Email haruki.uj@gmail.com

Sponsor
Institute Iwate Medical University
Institute
Department

Funding Source
Organization Iwate Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 12 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 30 Day
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 13 Day
Last modified on
2018 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039636

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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