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

• Status: Completed
• Trial end date: 2021-01-14
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Criteria

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.