Efficacy and Safety of HGP1910 and HCP1903 in Patients With Primary Hypercholesterolemia
NCT ID: NCT04652349
Last Updated: 2021-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
279 participants
INTERVENTIONAL
2020-07-06
2021-01-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HGP1910
HGP1910
Take it once daily for 8 weeks orally.
HCP1903
HCP1903
Take it once daily for 8 weeks orally.
HGP1909
HGP1909
Take it once daily for 8 weeks orally.
HGP1911
HGP1911
Take it once daily for 8 weeks orally.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
19 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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HM-ROZE-302
Identifier Type: -
Identifier Source: org_study_id
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