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

Primary Purpose

Primary Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HGP1910
HCP1903
HGP1909
HGP1911
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hypercholesterolemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

HGP1910

HCP1903

HGP1909

HGP1911

Arm Description

Outcomes

Primary Outcome Measures

Percentage change(%) from baseline in LDL-C at week 8

Secondary Outcome Measures

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

Full Information

First Posted
November 26, 2020
Last Updated
March 4, 2021
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04652349
Brief Title
Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia
Official Title
A Randomized, Double-Blinded, Multi-center, Phase 3 Study to Evaluate Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
December 17, 2020 (Actual)
Study Completion Date
January 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
279 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HGP1910
Arm Type
Experimental
Arm Title
HCP1903
Arm Type
Experimental
Arm Title
HGP1909
Arm Type
Active Comparator
Arm Title
HGP1911
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
HGP1910
Intervention Description
Take it once daily for 8 weeks orally.
Intervention Type
Drug
Intervention Name(s)
HCP1903
Intervention Description
Take it once daily for 8 weeks orally.
Intervention Type
Drug
Intervention Name(s)
HGP1909
Intervention Description
Take it once daily for 8 weeks orally.
Intervention Type
Drug
Intervention Name(s)
HGP1911
Intervention Description
Take it once daily for 8 weeks orally.
Primary Outcome Measure Information:
Title
Percentage change(%) from baseline in LDL-C at week 8
Time Frame
baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Percentage change(%) from baseline in LDL-C at week 4
Time Frame
baseline, 4 weeks
Title
Percentage change(%) from baseline in LDL-C, TC, HDL-C, non-HDL-C
Time Frame
baseline, 4 weeks, 8 weeks
Title
Percentage change(%) from baseline in Apo A1, Apo B, lipoprotein (a)
Time Frame
baseline, 4 weeks, 8 weeks
Title
Proportion of subjects achieving LDL-C treatment goals by cardiovascular Risk Category
Time Frame
baseline, 4 weeks, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
34429197
Citation
Lee SA, Kim W, Hong TJ, Ahn Y, Kim MH, Hong SJ, Kim BS, Kim SY, Chae IH, Kim BJ, Rhee MY, Shin JH, Kang TS, Cho JM, Kim JS, Lee CW. Effects of Fixed-dose Combination of Low-intensity Rosuvastatin and Ezetimibe Versus Moderate-intensity Rosuvastatin Monotherapy on Lipid Profiles in Patients With Hypercholesterolemia: A Randomized, Double-blind, Multicenter, Phase III Study. Clin Ther. 2021 Sep;43(9):1573-1589. doi: 10.1016/j.clinthera.2021.07.016. Epub 2021 Aug 21.
Results Reference
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Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia

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