To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia
NCT ID: NCT04584736
Last Updated: 2021-12-01
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
283 participants
INTERVENTIONAL
2019-06-11
2020-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Livalo 2mg, Ezetrol 10mg
Pitavastatin 2mg, Ezetimibe 10mg
Livalo, Ezetrol
Pitavastatin+Ezetimibe Pitavastatin
Livalo 2mg
Pitavastatin 2mg
Livalo, Ezetrol
Pitavastatin+Ezetimibe Pitavastatin
Livalo 4mg, Ezetrol 10mg
Pitavastatin 4mg, Ezetimibe 10mg
Livalo, Ezetrol
Pitavastatin+Ezetimibe Pitavastatin
Livalo 4mg
Pitavastatin 4mg
Livalo, Ezetrol
Pitavastatin+Ezetimibe Pitavastatin
Interventions
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Livalo, Ezetrol
Pitavastatin+Ezetimibe Pitavastatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
19 Years
79 Years
ALL
No
Sponsors
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JW Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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dongryeong lee, Manager
Role: STUDY_CHAIR
+82-2-840-6982
Locations
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Gangdong Sacred Heart Hospital
Seoul, Korea, South Korea
Countries
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References
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Jeong HS, Hong SJ, Cho JM, Han KH, Cha DH, Jo SH, Kang HJ, Choi SY, Choi CU, Cho EJ, Jeong YH, Gwon HC, Kim BK, Lee SY, Kim SH, Ahn JC, Hong YJ, Kim WS, Woo SI, Park TH, Han KR. A Multicenter, Randomized, Double-blind, Active-controlled, Factorial Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia. Clin Ther. 2022 Oct;44(10):1310-1325. doi: 10.1016/j.clinthera.2022.09.001. Epub 2022 Oct 12.
Other Identifiers
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JWP-PTZ-301
Identifier Type: -
Identifier Source: org_study_id