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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04652349
Other study ID # HM-ROZE-302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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