Unique ID issued by UMIN | UMIN000002698 |
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Receipt number | R000003290 |
Scientific Title | Open-labeled randomized parallel trial to compare the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of standard atorvastatin administration. |
Date of disclosure of the study information | 2009/11/02 |
Last modified on | 2017/10/22 17:15:29 |
Open-labeled randomized parallel trial to compare the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of standard atorvastatin administration.
Comparison of the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of atorvastatin administration.
Open-labeled randomized parallel trial to compare the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of standard atorvastatin administration.
Comparison of the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of atorvastatin administration.
Japan |
coronary artery disease
Cardiology |
Others
NO
Comparison of the efficacy between ezetimib and atorvastatin as an additional medication in metabolic syndrome patients with a history of coronary artery disease who do not achieve target LDL-cholesterol goal in spite of atorvastatin administration.
Efficacy
Change of LDL-C
1) Changes of RLP-C, hs-CRP, lipid peroxidation, Non HDL-C, Non HDL-C/HDL-C, LDL-C/HDL-C, TC, TG, HDL-C.
2) Change of insulin resistance.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
Patients who have more than 100mg/dL of LDL-C in spite of taking atorvastatin 10mg/day will be additionally administered another 10mg/day of atorvastatin for 6 months.
Patients who have more than 100mg/dL of LDL-C in spite of taking atorvastatin 10mg/day will be additionally administered ezetimib 10mg/day for 6 months.
Not applicable |
Not applicable |
Male and Female
1) Patients who have a history of myocardial infarction or angina pectoris diagnosed by coronary angiography, or have more than 25% stenosis in coronary artery assessed by MDCT.
2) Patients who meet a criteria for metabolic syndrome (NCEP-ATP3 2004 with some modifications)
3) Patients who have more than 100mg/dL of LDL-C in spite of taking atorvastatin 10mg/day for at least 3 month.
1) Patients with more than 500mg/dL of triglyceride.
2) Patients with hepatic dysfunction [ALT>3 x upper limit of normal range.]
3) Patients with renal dysfunction [Serum creatinine >2 x upper limit of normal range]
4) Patients with a history of myocardial infarction, unstable angina, CABG operation or stroke within recent 3 months.
5) Patients with uncontrolled diabetes mellitus (HbA1c>9%).
6) Patients with a history of drug-allergy (shock, anaphylaxis, vascular edema).
7) Patients taking immune-suppressor.
8) Patients with familial hypercholesterolemia.
9) Patients with secondary hyperlipidemia.
10) Alcohol abusers.
11) Patients with drug-induced hyperlipidemia (steroid, or other medicine)
12) Pregnant or possibly pregnant women. Those who want or are wanted by the partner to be pregnant.
13) Patients hypersensitive with this medicine and /or contaminants of this medicine.
14) Patients who are judged to be inappropriate as a subject by a doctor.
120
1st name | |
Middle name | |
Last name | Morihiro Matsuda |
National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
Department of Cardiology
3-1 Aoyamacho, Kure, Hiroshima
1st name | |
Middle name | |
Last name | Morihiro Matsuda |
National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
Department of Cardiology
morihiro-m@kure-nh.go.jp
National Hospital Organization, Kure Medical Center and Chugoku Cancer Center
none
Self funding
NO
独立行政法人国立病院機構呉医療センター・中国がんセンター(広島県)
2009 | Year | 11 | Month | 02 | Day |
Unpublished
Terminated
2009 | Year | 06 | Month | 12 | Day |
2009 | Year | 11 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2009 | Year | 11 | Month | 01 | Day |
2017 | Year | 10 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003290
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