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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Primary Hypercholesterolemia

Treatments: Drug: HGP1909; Drug: HGP1910; Drug: HCP1903; Drug: HGP1911

Study type: Interventional

Funder types: Industry

Identifiers

NCT04652349

HM-ROZE-302

Details and patient eligibility

About

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

Enrollment: 279 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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279 participants in 4 patient groups

HGP1910

Experimental group

Treatment:

Drug: HGP1910

HCP1903

Experimental group

Treatment:

Drug: HCP1903

HGP1909

Active Comparator group

Treatment:

Drug: HGP1909

HGP1911

Active Comparator group

Treatment:

Drug: HGP1911