None listed
Conditions
Interventions
Drug : 1.HL140 5/10(Rosuvastatin(5mg)/Ezetimibe 10mg QD(take 1 capsule once a day)/8weeks(extension:20 weeks).PO(An oral agent)
2.HL140 10/10(Rosuvastatin(10mg)/Ezetimibe 10mg QD(take 1 capsule once
Sponsors
Daegu Catholic Univercity Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Aged over 19 years •Signed informed consent form •At visit 1 and visit 2(pre-visit2), LDL-Cholesterol = 250mg/dL and Triglyderide = 400mg/dL after 4 weeks(at least) TLC(Therapeutic Lifestyle Change) and meet requirements for 4 group below. ? high-risk group: CHD(Coronary Heart Disease) or equal to CHD(Coronary Heart Disease) risk factor(10-yaear risk=20%), 100=LDL-C(mg/dL)=250 , TG(mg/dL)=400 ? moderate high-risk group:having at least 2 risk factor, 10%=10-yaear risk<20%, 130=LDL-C(mg/dL)=250 , TG(mg/dL)=400 ? moderate-risk grop: having at least 2 risk factor, 10-yaear risk<10% 160= LDL-C(mg/dL)=250 , TG(mg/dL)=400 ? low-risk group: having 0~1 rkisk factor, 160= LDL-C(mg/dL)=250 , TG(mg/dL)=400
Exclusion criteria
Exclusion criteria: 1)At visit 1, BMI = 30kg/? 2)Has a history of myopathy or rhabdomyolysis cased by statin treatment, hereditary myopathy or family history and hypersensitivity to satin(HMG-CoA reductase inhibitor) and component of ezeimibe 3)Has a Severe renal disorder(Ccr 2 x upper limit of normal 5)alanine aminotransferase(ALT) or aspartate aminotransferase(AST) > 3 x upper limit of normal 6)Has a activity/chronic hepatic disease or HIV-positive 7)Has a endocrine or metabolic diseases known to affect the serum phospholipid or poprotein Uncontrolled diabete mellitus(HbA1c =9%) Hypothyroidism (thyroid-stimulating hormone(TSH) > 1.5 x upper limit of normal at the screening ) 8)Uncontrolled hypertension ((systolic blood pressure(SBP) =180mmHg ?? diastolic blood pressure(DBP) =110mmHg) 9)Has a acute arteriopathy(history of unstable angina, cardiac infarction, transient ischemic stroke, cerebrovascular disease, coronary artery bypass, coronary intervention within 12 weeks prior to screening) 10)Congestive heart failure (New York Heart Association(NYHA)Class III or IV) 11)Has a drugs absortion disorder by gastrointestinal surgery or gastrointestinal disorder 12)History of malignant tumor including myelogenous and lymphoma within 5 years 13)Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption 14)Female subjects of childbearing potential who disagree with the contraceptive methods(surgical sterilization, intrauterine device or condoms) 15)Pregnant or breast-feeding 16)Patients who have a drug or alcohol abuse or are being treated for psychological disorder. 17)Patients who were treated with other clinical trial drug within 12 weeks prior to screening 18)Others; patients considered inappropriate to participate in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of change in LDL-Cholesterol | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of change in LDL-Cholesterol ;Percentage of change in TG ;Percentage of change in TC ;Percentage of change in non-HDL-Cholesterol;Percentage of change in HDL-Cholesterol;Percentage of change weeks in Apo A-I ;Percentage of change in Apo B;Percentage of change in Lipoprotein(a) ;The rate of change in hs-CRP ;Percentage of patients reaching treatment goals according to NCEP ATP III Guideline | — |
Countries
Korea, Republic of
Contacts
Public Contactkeesik Kim
Daegu Catholic Univercity Medical Center
Outcome results
None listed