Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia

A Randomized, Double-Blinded, Multi-center, Phase 3 Study to Evaluate Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia

The purpose of this study is to investigate the safety and clinical efficacy of HGP1910 and HCP1903 in patients with primary hypercholesterolemia

Inclusion Criteria:

• Participants aged ≥ 19 years
• Participants who have voluntarily given written consent to participate in this clinical trial
• Participants with LDL-C ≤ 250mg/dL and TG < 500mg/dL at Visit 1
• Participants with LDL-C ≤ 250mg/dL, TG < 500 mg/dL and satisfied criteria according to cardiovascular risk category at Visit 2 (after at least 4 weeks of TLC)

Exclusion Criteria:

• Patients with active liver disease and severe liver impairment
• Patients with severe renal failure (eGFR < 30 mL/min/1.73 m2 at Visit 1)
• Patients with type I diabetes or uncontrolled type 2 diabetes
• Patients with acute hypertension or uncontrolled hypertension (sitSBP ≥ 180 mmHg or sitDBP ≥ 110 mmHg at Visit 1)
• Patients with symptomatic orthostatic hypotension
• Patients with NYHA class III~IV heart failure, CCSA class III~IV angina, ventricular arrhythmia, severe hemorrhagic or ischemic cerebrovascular diseases, transient ischemic attacks (TIAs), acute coronary syndrome or a history of angioplasty, percutaneous coronary intervention, or coronary artery bypass surgery within six months before Visit 1.
• Patients who were diagnosed with a malignant tumor within five years before Visit.