A Multi Center, Randomized, Double-blind, Parallel, Factorial Design, Therapeutic Phase III Study to Evaluate the Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia
A Multi Center, Randomized, Double-blind, Parallel, Factorial Design, Therapeutic Phase III Study to Evaluate the Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia
The purpose of this study is to evaluate efficacy and safety of HL140 in patients with primary hypercholesterolemia.
The purpose of this study is to demonstrate that the efficacy of combination drug of rosuvastatin/ezetimibe is superior to single rosuvastatin drug and to confirm the safety of combination drug of rosuvastatin/ezetimibe
Inclusion Criteria:
Exclusion Criteria:
At visit 1, BMI ≥ 30kg/㎡
Has a history of myopathy or rhabdomyolysis cased by statin treatment, hereditary myopathy or family history and hypersensitivity to statin(HMG-CoA reductase inhibitor) and component of ezetimibe
Has a Severe renal disorder(Ccr <30mL/min) or nephrotic syndrome
Creatine Kinase > 5 x upper limit of normal
ALT or AST > 3 x upper limit of normal
Has a activity/chronic hepatic disease or HIV-positive
Has a endocrine or metabolic diseases known to affect the serum phospholipid or protein
Uncontrolled hypertension (SBP ≥180mmHg or DBP ≥110mmHg)
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)
Severe heart failure (NYHA Class III or IV)
Has a drug absorption disorder by gastrointestinal surgery or gastrointestinal disorder
History of malignant tumor including myelogenous and lymphoma within 5 years (Participation is possible, if the tumor has not recurred for more than 5 years)
Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
Female subjects of childbearing potential who disagree with the contraceptive methods(surgical sterilization, intrauterine device or condoms)
Pregnant or breast-feeding
Patients who have a drug or alcohol abuse or are being treated for psychological disorder
Patients who were treated with other investigational drug within 12 weeks prior to screening
Other patients who are inappropriate to participate in the study considered by the investigator or other study staffs