Unique ID issued by UMIN | UMIN000000935 |
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Receipt number | R000000995 |
Scientific Title | Research on safety and effect of lipid improvement of rosuvastatin combined with fenofibrate or EPA in type 2 diabetic patients with hyperlipidemia. |
Date of disclosure of the study information | 2008/09/01 |
Last modified on | 2007/12/06 18:59:20 |
Research on safety and effect of lipid improvement of rosuvastatin combined with fenofibrate or EPA in type 2 diabetic patients with hyperlipidemia.
Research on safety and effect of lipid improvement of rosuvastatin combined with fenofibrate or EPA in type 2 diabetic patients with hyperlipidemia.
Research on safety and effect of lipid improvement of rosuvastatin combined with fenofibrate or EPA in type 2 diabetic patients with hyperlipidemia.
Research on safety and effect of lipid improvement of rosuvastatin combined with fenofibrate or EPA in type 2 diabetic patients with hyperlipidemia.
Japan |
type 2 diabetic patients with hyperlipidemia
Medicine in general | Endocrinology and Metabolism |
Others
NO
Research on safety and effect of lipid improvement of rosuvastatin combined with fenofibrate in type 2 diabetic patients with hyperlipidemia.
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
% change in TG, HDL-C and LDL-C at 24 weeks
Include assesment of ALT, SCr, CK(CPK) and at 24 weeks
Change of the concentration of serum rosuvastatin at 24 weeks
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
4
Treatment
Medicine |
Following a 8 weeks medication with rosuvastatin 2.5mg, subjects with not achieved NCEP ATPIII goal will be receive treatment with fenofibrate 200-201mg for 24 weeks.
Following a 8 weeks medication with rosuvastatin 2.5mg, subjects with not achieved NCEP ATPIII goal will be receive treatment with EPA 1800mg for 24 weeks.
Following a 8 weeks medication with fenofibrate 200-201mg, subjects with not achieved NCEP ATPIII goal will be receive treatment with rosuvastatin 2.5mg for 24 weeks.
Following a 8 weeks medication with EPA 1800mg, subjects with not achieved NCEP ATPIII goal will be receive treatment with rosuvastatin 2.5mg for 24 weeks.
18 | years-old | <= |
70 | years-old | > |
Male and Female
Type 2 diabetic patients taking medication with rosuvastatin 2.5mg or fenofibrate 200-201mg or EPA 1800mg more than 8 weeks but not achieved NCEP ATPIII goals.
The patient with liver or kidney disfunction or abnormality of CK
200
1st name | |
Middle name | |
Last name | Nobuoki Kohono |
Hiroshima University Graduate School of Biomedical Sciences Department of Molecular and Internal Medicine
Division of Clinical Medical Science Programs for Applied Biomedicine
1-2-3Kasumi, Minami-ku Hiroshima Japan
082-257-5196
1st name | |
Middle name | |
Last name | Hiroshi Watanabe |
Hiroshima University Hospital
Department of Endoclinology
1-2-3Kasumi, Minami-ku Hiroshima Japan
082-257-5196
drhiroshi@hiroshima-u.ac.jp
Hiroshima University Hospital Department of Endoclinology
None
Self funding
NO
2008 | Year | 09 | Month | 01 | Day |
Unpublished
2007 | Year | 07 | Month | 02 | Day |
2007 | Year | 10 | Month | 01 | Day |
2010 | Year | 09 | Month | 01 | Day |
2007 | Year | 12 | Month | 06 | Day |
2007 | Year | 12 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000995
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