A multi center, randomized, double-blind, parallel, factorial design, therapeutic confirmatory(phase III) study to evaluate the efficacy and safety of combination of Rosuvastatin and Ezetimibe in patients with primary hypercholesterolemia
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0001831
- Lead Sponsor
- Daegu Catholic Univercity Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 420
•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
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 <30mL/min) or nephrotic syndrome
4)Creatine Kinase > 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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of change in LDL-Cholesterol
- Secondary Outcome Measures
Name Time Method 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