Unique ID issued by UMIN | UMIN000034880 |
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Receipt number | R000039636 |
Scientific Title | 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 | 2021/05/20 09:55:26 |
Clinical studies on antihypertensive drugs used for proteinuria and hypertension intended for the bevacizumab-treated patients
Study on the effectiveness of antihypertensive drugs on proteinuria and hypertension of bevacizumab-treated patients
Clinical studies on antihypertensive drugs used for proteinuria and hypertension intended for the bevacizumab-treated patients
Study on the effectiveness of antihypertensive drugs on proteinuria and hypertension of bevacizumab-treated patients
Japan |
colorectal cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To examine the effectiveness of the ARB and CCB for the bevacizumab-induced proteinuria and hypertension.
Safety,Efficacy
Rate of decrease in proteinuria
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Azilsartan Oral administration once a day(max 6 month)
Amlodipine Oral administration once a day(max 6 month)
20 | years-old | <= |
85 | years-old | >= |
Male and Female
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
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
70
1st name | Kenzo |
Middle name | |
Last name | Kudo |
Iwate Medical University
Division of Clinical Pharmaceutics and Pharmacy Practice, Department of Clinical Pharmacy, School of Pharmacy, Iwate Medical University
0283609
1-1-1, Idaidori, Yahaba-cho, Shiwagun, Iwate, Japan
019-613-7111
kenzkudo@iwate-med.ac.jp
1st name | Satoru |
Middle name | |
Last name | Nihei |
Iwate Medical University
Faculty of clinical pharmacy course
0283609
1-1-1, Idaidori, Yahaba-cho, Shiwagun, Iwate, Japan
019-613-7111
satoru.2hei@gmail.com
Iwate Medical University
Iwate Medical University
Self funding
Iwate Medical University
1-1-1, Idaidori, Yahaba-cho, Shiwagun, Iwate, Japan
019-613-7111
satoru.2hei@gmail.com
NO
2018 | Year | 12 | Month | 01 | Day |
Unpublished
Completed
2018 | Year | 11 | Month | 30 | Day |
2019 | Year | 01 | Month | 10 | Day |
2019 | Year | 02 | Month | 01 | Day |
2020 | Year | 03 | Month | 31 | Day |
2018 | Year | 11 | Month | 13 | Day |
2021 | Year | 05 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039636
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