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

March 4, 2021 updated by: Hanmi Pharmaceutical Company Limited

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HGP1910
Drug: HGP1910
Take it once daily for 8 weeks orally.
Experimental: HCP1903
Drug: HCP1903
Take it once daily for 8 weeks orally.
Active Comparator: HGP1909
Drug: HGP1909
Take it once daily for 8 weeks orally.
Active Comparator: HGP1911
Drug: HGP1911
Take it once daily for 8 weeks orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change(%) from baseline in LDL-C at week 8
Time Frame: baseline, 8 weeks
baseline, 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2020

Primary Completion (Actual)

December 17, 2020

Study Completion (Actual)

January 14, 2021

Study Registration Dates

First Submitted

November 26, 2020

First Submitted That Met QC Criteria

November 26, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-ROZE-302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Hypercholesterolemia

Clinical Trials on HGP1910

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe