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

Phase 3

Completed

• Conditions: Primary Hypercholesterolemia
• Interventions: Drug: HGP1911; Drug: HGP1909; Drug: HGP1910; Drug: HCP1903

• Registration Number: NCT04652349
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-06
• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-11-26
• Study First Posted: 2020-12-03
• Primary Completion: 2020-12-17
• Study Completion: 2021-01-14
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HGP1911	HGP1911	-
HGP1909	HGP1909	-
HGP1910	HGP1910	-
HCP1903	HCP1903	-

Primary Outcome Measures

Name	Time	Method
Percentage change(%) from baseline in LDL-C at week 8	baseline, 8 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage change(%) from baseline in LDL-C, TC, HDL-C, non-HDL-C	baseline, 4 weeks, 8 weeks
Percentage change(%) from baseline in Apo A1, Apo B, lipoprotein (a)	baseline, 4 weeks, 8 weeks
Percentage change(%) from baseline in LDL-C at week 4	baseline, 4 weeks
Proportion of subjects achieving LDL-C treatment goals by cardiovascular Risk Category	baseline, 4 weeks, 8 weeks

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of