Unique ID issued by UMIN | UMIN000025620 |
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Receipt number | R000029476 |
Scientific Title | A comparative clinical trial on the effects of atorvastatin 10mg and atorvastatin 5mg/ ezetimibe 10mg in type 2 diabetic patients with nephropathy and hypercholesterolemia |
Date of disclosure of the study information | 2017/01/13 |
Last modified on | 2017/01/11 14:04:46 |
A comparative clinical trial on the effects of atorvastatin 10mg and atorvastatin 5mg/ ezetimibe 10mg in type 2 diabetic patients with nephropathy and hypercholesterolemia
Comparison of the effects of atorvastatin high dose and atorvastatin/ezetimibe combination therapy
A comparative clinical trial on the effects of atorvastatin 10mg and atorvastatin 5mg/ ezetimibe 10mg in type 2 diabetic patients with nephropathy and hypercholesterolemia
Comparison of the effects of atorvastatin high dose and atorvastatin/ezetimibe combination therapy
Japan |
Type 2 diabetic patients with nephropathy and hypercholesterolemia
Endocrinology and Metabolism |
Others
NO
Comparison of the effects of atorvastatin 10mg and atorvastatin 5mg/ezetimibe10mg on lipid profile, renal function and safety in type 2 diabetic patients with nephropathy and hypercholesterolemia.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Changes in non-HDL cholesterol at 12 weeks after administration
Change in lipid profile (TC, LDL-C, HDL-C, TG, RLP), parameters related to renal function (urine albuminm, urine collagen IV, L-FABP), parameters related to glucose metabolism (fasting glucose, HbA1c), and safety at 12 weeks after administration
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
NO
Central registration
2
Treatment
Medicine |
Each subject will orally receive atorvastatin 10mg once daily for 3 months.
Each subject will orally receive atorvastatin 5mg and ezetimibe 10mg once daily for 3 months.
20 | years-old | <= |
Not applicable |
Male and Female
1) During of atorvastatin (5mg once daily) treatment more than 3 months
2) LDL-C>=100mg/dL
3) CKD stage G3a and G3b (30<=eGFR<60)
4) Age>=20 years old
5) No change in medication of lipid-lowering and antidiabetic drug within 12 weeks
6) 6.5%<=HbA1c<=8% (NGSP)
7) Patients with written IC
1) Patients with hypersensitivity of the test drugs
2) Patients with hepatic dysfunction(AST or ALT>=100U)
3) Patients with a past history of cerebrovascular or cardiovascular event
4) Patients with secondary or drug-induced hyperlipidemia
5) Patients with familial hypercholesterolemia
6) Pregnant or possibly pregnant patients, patients on lactation
7) Patients with insulin treatment
8) Patients with fibrate treatment
9) Inappropriate patients for this study according to the judgment of Investigator
40
1st name | |
Middle name | |
Last name | Nobuichi Kuribayashi |
Misaki Naika Clinic
Internal medicine
6-44-9, Futawa-higashi, Funabashi city, Chiba
047-440-2222
n-kuribayashi@am.wakwak.com
1st name | |
Middle name | |
Last name | Nobuichi Kuribayashi |
Misaki Naika Clinic
Internal medicine
6-44-9, Futawa-higashi, Funabashi city, Chiba
047-440-2222
n-kuribayashi@am.wakwak.com
Misaki Naika Clinic
Bayer Yakuhin, Ltd.
Profit organization
Japan
NO
三咲内科クリニック
2017 | Year | 01 | Month | 13 | Day |
Unpublished
Compared with the atorvastatin group, the rate of reduction of non HDL-C and LDL-C was significantly larger in the ezetimibe group. Renal marker and safety did not differ between the two groups.
Completed
2013 | Year | 11 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2015 | Year | 11 | Month | 30 | Day |
2016 | Year | 01 | Month | 14 | Day |
2016 | Year | 02 | Month | 22 | Day |
2016 | Year | 03 | Month | 25 | Day |
2017 | Year | 01 | Month | 11 | Day |
2017 | Year | 01 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029476
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