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

Sponsor

Hanmi Pharmaceutical Company Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT04652349

Collaborator

(none)

279

Enrollment

Location

Arms

6.3

Actual Duration (Months)

44.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Primary Hypercholesterolemia	Drug: HGP1910 Drug: HCP1903 Drug: HGP1909 Drug: HGP1911	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

279 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 6, 2020

Actual Primary Completion Date :

Dec 17, 2020

Actual Study Completion Date :

Jan 14, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Percentage change(%) from baseline in LDL-C at week 8 [baseline, 8 weeks]

Secondary Outcome Measures

Percentage change(%) from baseline in LDL-C at week 4 [baseline, 4 weeks]
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]
Proportion of subjects achieving LDL-C treatment goals by cardiovascular Risk Category [baseline, 4 weeks, 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT04652349

Other Study ID Numbers:

HM-ROZE-302

First Posted:

Dec 3, 2020

Last Update Posted:

Mar 5, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypercholesterolemia

Study Results

No Results Posted as of Mar 5, 2021