Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia

Launched by HANLIM PHARM. CO., LTD. · Jun 17, 2018

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged over 19 years
• • Signed informed consent form
• • At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyceride ≤ 400mg/dL
• 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 diabetes mellitus(HbA1c ≥9%)
• • Hypothyroidism (TSH \> 1.5 x upper limit of normal rate at the screening )
• • 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