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

NCT04652349 | Completed Phase 3

• 1 other identifier: HM-ROZE-302
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percentage change(%) from baseline in LDL-C at week 8

  baseline, 8 weeks

Secondary Outcomes (4)

• 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

Study Arms (4)

HGP1910

EXPERIMENTAL

Drug: HGP1910

HCP1903

EXPERIMENTAL

Drug: HCP1903

HGP1909

ACTIVE COMPARATOR

Drug: HGP1909

HGP1911

ACTIVE COMPARATOR

Drug: HGP1911

Interventions

HGP1910 DRUG

Take it once daily for 8 weeks orally.

HGP1910

HCP1903 DRUG

Take it once daily for 8 weeks orally.

HCP1903

HGP1909 DRUG

Take it once daily for 8 weeks orally.

HGP1909

HGP1911 DRUG

Take it once daily for 8 weeks orally.

HGP1911

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 34429197 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: July 6, 2020
• Primary Completion: December 17, 2020
• Study Completion: January 14, 2021
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

KR (1)