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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate efficacy and safety of HL140 in patients with primary hypercholesterolemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanlim Pharm. Co., Ltd.
• Treatments: Ezetimibe; Rosuvastatin Calcium

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