Clinical trial NCT04652349: Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Hypercholesterolemia
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2020-12-03
Enrollment: 279
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage change(%) from baseline in LDL-C at week 8
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Percentage change(%) from baseline in LDL-C at week 4
timeFrame: baseline, 4 weeks
measure: Percentage change(%) from baseline in LDL-C, TC, HDL-C, non-HDL-C
timeFrame: baseline, 4 weeks, 8 weeks
measure: Percentage change(%) from baseline in Apo A1, Apo B, lipoprotein (a)
timeFrame: baseline, 4 weeks, 8 weeks
measure: Proportion of subjects achieving LDL-C treatment goals by cardiovascular Risk Category
timeFrame: baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
citation: Lee SA, Kim W, Hong TJ, Ahn Y, Kim MH, Hong SJ, Kim BS, Kim SY, Chae IH, Kim BJ, Rhee MY, Shin JH, Kang TS, Cho JM, Kim JS, Lee CW. Effects of Fixed-dose Combination of Low-intensity Rosuvastatin and Ezetimibe Versus Moderate-intensity Rosuvastatin Monotherapy on Lipid Profiles in Patients With Hypercholesterolemia: A Randomized, Double-blind, Multicenter, Phase III Study. Clin Ther. 2021 Sep;43(9):1573-1589. doi: 10.1016/j.clinthera.2021.07.016. Epub 2021 Aug 21.