Unique ID issued by UMIN | UMIN000007362 |
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Receipt number | R000008662 |
Scientific Title | An investigation of the serum uric acid-lowering effects of febuxostat in gout/hyperuricemia patients according to disease type |
Date of disclosure of the study information | 2012/02/23 |
Last modified on | 2013/09/10 18:44:53 |
An investigation of the serum uric acid-lowering effects of febuxostat in gout/hyperuricemia patients according to disease type
FORTUNE-2
An investigation of the serum uric acid-lowering effects of febuxostat in gout/hyperuricemia patients according to disease type
FORTUNE-2
Japan |
Hyperuricemia and gout
Medicine in general | Endocrinology and Metabolism |
Others
NO
An open-label, non-comparative study on the serum uric acid-lowering effects of febuxostat in gout/hyperuricemia patients according to disease type
Safety,Efficacy
Not applicable
The serum uric acid-lowering rate at Week 12
- The goal attainment rate for serum uric acid level of 6.0 mg/dL or lower at Week 12
- The uric acid-lowering effects at Weeks 4 and 8 [serum uric acid-lowering rate, goal attainment rate (serum uric acid level of 6.0 mg/dL or lower)]
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Patients who fulfill all three of the criteria below are eligible for the study:
1) Gout/hyperuricemia patients who have not been treated with any uric acid-lowering drugs during the two weeks prior to obtainment of informed consent and have serum uric acid level of 7.0 mg/dL or higher
2) Patients aged 20 years or older at the time of obtainment of informed consent (regardless of sex and inpatient/outpatient status)
3) Patients who consent in writing to participate in the study
Patients who meet any of the 10 criteria below are ineligible for the study:
1) Patients who have a past history of hypersensitivity to febuxostat
2) Secondary hyperuricemia patients
3) Patients who have twice as high AST or ALT as the hospital's reference value
4) Males with serum creatinine level of 2.0 mg/dL or higher and females with serum creatinine level of 1.5 mg/dL or higher
5) Patients who have or have had past history of malignant tumor as a complication requiring treatment
6) Patients who are being treated with either mercaptopurine hydrate or azathioprine
7) Patients who are undergoing hormone replacement therapy (HRT)
8) Patients who are or are likely to become pregnant, and those who are lactating
9) Patients who participated in another clinical study or clinical trial in the six months prior to the confirmation of eligibility
10) Patients who the doctor in charge judges are ineligible for the study
100
1st name | |
Middle name | |
Last name | Tetsuya Yamamoto |
Hyogo College of Medicine
Endocrinology and Metabolism, Department of Internal Medicine
1-1, Mukogawa-cho, Nishinomiya, Hyogo
0798-45-6472
1st name | |
Middle name | |
Last name | Takashi Oi |
Mebix, Inc.
Clinical Research III
1-11-44 Akasaka, Minato-ku, Tokyo, Japan
03-6229-8936
fortune@mebix.co.jp
Clinical research consortium on uric acid
Teijin Pharma Limited
Profit organization
Japan
NO
2012 | Year | 02 | Month | 23 | Day |
Unpublished
Completed
2012 | Year | 01 | Month | 31 | Day |
2012 | Year | 04 | Month | 01 | Day |
2013 | Year | 04 | Month | 01 | Day |
NA
2012 | Year | 02 | Month | 23 | Day |
2013 | Year | 09 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008662
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