Primary Hypercholesterolemia
Conditions
Brief summary
The purpose of this study is to investigate the safety and clinical efficacy of HGP1910 and HCP1903 in patients with primary hypercholesterolemia
Interventions
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change(%) from baseline in LDL-C at week 8 | baseline, 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed