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

Primary Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04652349
• Other study ID #: HM-ROZE-302
• Status: Completed
• Phase: Phase 3
• Start date: July 6, 2020
• Est. completion date: January 14, 2021

Study information

• Verified date: March 2021
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: January 14, 2021
• Est. primary completion date: December 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia
• Primary Hypercholesterolemia

Intervention

Drug:
• HGP1910
Take it once daily for 8 weeks orally.
• HCP1903
Take it once daily for 8 weeks orally.
• HGP1909
Take it once daily for 8 weeks orally.
• HGP1911
Take it once daily for 8 weeks orally.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change(%) from baseline in LDL-C at week 8		baseline, 8 weeks
Secondary	Percentage change(%) from baseline in LDL-C at week 4		baseline, 4 weeks
Secondary	Percentage change(%) from baseline in LDL-C, TC, HDL-C, non-HDL-C		baseline, 4 weeks, 8 weeks
Secondary	Percentage change(%) from baseline in Apo A1, Apo B, lipoprotein (a)		baseline, 4 weeks, 8 weeks
Secondary	Proportion of subjects achieving LDL-C treatment goals by cardiovascular Risk Category		baseline, 4 weeks, 8 weeks