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Completed

NCT Number: NCT04652349

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

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Key information

Conditions

Primary Hypercholesterolemia

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HGP1910

Drug

Take it once daily for 8 weeks orally.

HCP1903

Drug

Take it once daily for 8 weeks orally.

HGP1909

Drug

Take it once daily for 8 weeks orally.

HGP1911

Drug

Take it once daily for 8 weeks orally.

Primary outcomes

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

    Time frame: baseline, 8 weeks

Secondary outcomes

  1. Percentage change(%) from baseline in LDL-C at week 4

    Time frame: baseline, 4 weeks

  2. Percentage change(%) from baseline in LDL-C, TC, HDL-C, non-HDL-C

    Time frame: baseline, 4 weeks, 8 weeks

  3. Percentage change(%) from baseline in Apo A1, Apo B, lipoprotein (a)

    Time frame: baseline, 4 weeks, 8 weeks

  4. Proportion of subjects achieving LDL-C treatment goals by cardiovascular Risk Category

    Time frame: baseline, 4 weeks, 8 weeks

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Randomized, Double-Blinded, Multi-center, Phase 3 Study to Evaluate Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 3, 2020
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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