Unique ID issued by UMIN | UMIN000006796 |
---|---|
Receipt number | R000008041 |
Scientific Title | Standard versus intensive therApy by Rosuvastatin for lipiD lowering |
Date of disclosure of the study information | 2011/12/01 |
Last modified on | 2014/06/04 09:48:38 |
Standard versus intensive therApy by Rosuvastatin for lipiD lowering
SARD
Standard versus intensive therApy by Rosuvastatin for lipiD lowering
SARD
Japan |
Hyperlipemia
Medicine in general | Cardiology |
Others
NO
For a hyperlipemic patient, examine the validity and safety of rosuvastatin high-dose medical treatment.
Efficacy
Confirmatory
change of the inflammation marker at the time of registration and 12 weeks after. (Hs-CRP,RLP-cholesterol,MDA-LDL,small dense LDL,HMW-adioponectin,RAGE)
The serum lipid improvement effect of 4 weeks and 12 weeks after.
(LDL-cholesterol,TG,HDL-cholesterol,
LDL/HDL ratio)
Interventional
Parallel
Randomized
Open -but assessor(s) are blinded
Dose comparison
YES
NO
Institution is not considered as adjustment factor.
Central registration
2
Treatment
Medicine |
Rosuvastatin high-dose medication group
Rosuvastatin low-dose medication group
20 | years-old | <= |
Not applicable |
Male and Female
he hyperlipemic subject who has not reached a lipid management target in the primary prevention (Category 3) or the secondary prevention patient set by the arteriosclerotic disease prevention guideline (2007)
1) Patients whom Rosuvastatin has already been prescribed
2) Familial hyperlipidemia or Secondary hyperlipemia
3) Patients with a history of hypersensitivity to statin
4) Patients who showed the symptoms of cerebrovascular disorder within 3months
5) Patients who showed the symptoms of myocardial infarction within 3 months
6) Patients diagnosed active liver disease(ALT or AST > 100 IU/L, T-bil > 2.5 mg/dL)
7) Patients with severe kidney dysfunction and also patients with poor control of kidney dysfunction
8)serum CK > 500 IU/L
9) Patients who are prescribing cyclosporin
10) Pregnant or lactating women
11) Decreased thyroid activity, A hereditary line disease(Muscular dystrophy etc) or patients with the family history, patients with the anamnesis of drug-induced muscle disorder
12) Drug abuse and/or patients of alcoholism
13)Patients who are considered not eligible for the study by the attending doctor due to other reasons
100
1st name | |
Middle name | |
Last name | Koichi Node |
Saga University Faculty of Medicine
Department of Cardiovascular medicine
5-1-1 Nabeshima, Saga-shi, Saga
0952-34-2364
node@cc.saga-u.ac.jp
1st name | |
Middle name | |
Last name | Junichi Oyama |
Saga University Faculty of Medicine
Department of Cardiovascular medicine
5-1-1 Nabeshima, Saga-shi, Saga
0952-34-2364
junoyama@cc.saga-u.ac.jp
Department of Cardiovascular medicine,
Saga University Faculty of Medicine
None
Self funding
Edogawa Hospital
NO
江戸川病院(東京都)、済生会唐津病院(佐賀県)、佐賀県立病院好生館(佐賀県)、佐賀大学病院(佐賀県)、伊万里有田共立病院(佐賀県)
2011 | Year | 12 | Month | 01 | Day |
Partially published
Completed
2011 | Year | 09 | Month | 05 | Day |
2011 | Year | 10 | Month | 01 | Day |
2012 | Year | 12 | Month | 30 | Day |
2013 | Year | 02 | Month | 25 | Day |
2013 | Year | 03 | Month | 12 | Day |
2011 | Year | 11 | Month | 30 | Day |
2014 | Year | 06 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008041
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