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
Verified date | March 2021 |
Source | Hanmi Pharmaceutical Company Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate the safety and clinical efficacy of HGP1910 and HCP1903 in patients with primary hypercholesterolemia
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Hanmi Pharmaceutical Company Limited |
Korea, Republic of,
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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