Hypercholesterolemia
Conditions
Interventions
Statin treatment Rosuvastatin 5mg
Combination treatment Rosuvastatin 2.5mg + ezetimibe 10mg
Sponsors
Jikei University School of Medicine,Kashiwa Hospital
Kashiwa Heart Clinic Fujiki Clinic Takeda Clinic Nedo Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) LDL-C level exceeds target LDL-C level(Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2007) after at least 4 weeks of rosuvastatin treatment 2) 5.5%<=HbA1c(NGSP)<6.5% or 110mg/dL<=fasting blood glucose<126mg/dL
Exclusion criteria
Exclusion criteria: 1) HbA1c>=6.5%(NGSP) 2) Hypersensitivity to test agents 3) Treating with antihyperlipidemic agents other than rosuvastatin 4) Severe hepatic dysfunction: any one of following (i)AST>=100IU/L (ii)ALT>=100IU/L (iii)Cirrhosis 5) Severe renal dysfunction: serum creatinine>=2.0mg/dL 6) History of acute coronary syndrome(myocardial infarction, angina) and stroke within 3 months 7) Secondary hyperlipidemia, drug induced hyperlipidemia 8) Pregnant, breast-feeding, becoming pregnant 9) Familial hypercholesterolemia 10) Inadequate to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of LDL-C level between groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes and comparison of each serum lipid level, Apolipo protein level, glucose metabolism level, laboratory test level, atherosclerosis index level, BMI, waist circumference, adverse event | — |
Countries
Japan
Contacts
Public ContactMitsuyuki SHIMIZU
Jikei University School of Medicine,Kashiwa Hospital Division of Cardiology Department of Internal Medicine
Outcome results
None listed