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Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT04652349•Hanmi Pharmaceutical Company Limited

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

19 - No limit years

Sex

ALL

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.

Locations (1)

Asan Medical Center

Seoul, South Korea

Key Dates

Start Date

July 6, 2020

Primary Completion Date

December 17, 2020

Completion Date

January 14, 2021

Last Updated

March 5, 2021

Enrollment

279

ACTUAL participants

Conditions

Primary Hypercholesterolemia

Interventions

HGP1910

DRUG

HCP1903

DRUG

HGP1909

DRUG

HGP1911

DRUG

A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib

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Primary HypercholesterolemiaMixed Dyslipidemia

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RECRUITINGPHASE3

A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia

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HypercholesterolemiaDyslipidemias+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib

A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia

Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD

QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated Low Density Lipoprotein Cholesterol (LDL-C)

QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia

An OS to Evaluate the Safety & Efficacy of Fixed Dose Combination Therapy With Atorvastatin and Ezetimibe