Unique ID issued by UMIN | UMIN000001472 |
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Receipt number | R000001790 |
Scientific Title | Clinical Trials for Effectiveness of Combination Therapy using Ezetimive and Rosuvastatin/Atorvastatin |
Date of disclosure of the study information | 2008/11/01 |
Last modified on | 2009/11/11 17:37:20 |
Clinical Trials for Effectiveness of Combination Therapy using Ezetimive and Rosuvastatin/Atorvastatin
CTE2RA
Clinical Trials for Effectiveness of Combination Therapy using Ezetimive and Rosuvastatin/Atorvastatin
CTE2RA
Japan |
IHD subjects who are taking rosvastatin 2.5mg or atorvastatin 10mg more than 3 months and whose LDL-C is > 100mg/dl.
Cardiology |
Others
NO
Comparisons between combination therapy (ezetimibe and statins) and statin alone therapy.
Safety,Efficacy
Confirmatory
total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, cholesterol absorption marker, cholesterol synthesis marker, glucose metabolic marker, inflammation marker, other laboratory findings.
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
Combination therapy wiht ezetimibe 10mg
Increase in dose for both statins.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Subjects who has a past history of coronary heart diseases with LDL-C >100mg/dl and who took rosuvastatin 2.5mg or atorvastatin 10mg more than 3 months. Age from 20 to 80. Gender free.
1)Subjects with hypersentivity for ezetimibe or staitns.
2)triglyceride>500mg/dl
3)liver dysfunction (AST>twice as much as the upperlimit of the facilities.
4)kidney dysfunction (serum Cr>2.0mg/dl)
5)secondary hyperlipidemia or drug induced hyperlipidemia
6)unstabel angina, myocardial infarction, coronary bypass surgery, brain infarction within 3 months.
7)pregnancy, lactation, possible pregnancy
8)According to the attending physician`s judgements
200
1st name | |
Middle name | |
Last name | Noriaki Iwahashi |
Yokohama City University Center Hospital
Department of Cardiology
Urafune, Minami, Yokohama
045-261-5656
1st name | |
Middle name | |
Last name | Kazuaki Uchino |
Department of Medicine and Cardio-renal Medicine
Department of Medicine and Cardio-renal Medicine
tommmish@med.yokohama-cu.ac.jp
Yokohama City University Graduate School of Medicine, Department of Medicine and Cardio-renal Medicine
Yokohama City University Center Hospital
Department of Cardiology
Self funding
NO
2008 | Year | 11 | Month | 01 | Day |
Unpublished
Open public recruiting
2008 | Year | 09 | Month | 01 | Day |
2008 | Year | 10 | Month | 01 | Day |
2010 | Year | 09 | Month | 01 | Day |
2008 | Year | 11 | Month | 01 | Day |
2009 | Year | 11 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001790
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