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Recruiting
NCT05657574
A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia
Conditions: Primary Hypercholesterolemia
Sex: All
Ages: 19 Years – N/A
Phase: PHASE3
Enrollment: 228
Sponsor: Chong Kun Dang Pharmaceutical
Location: Korea, Republic of
Summary
This is a randomized, double-blind, multi-center, therapeutic confirmatory, phase 3 trial to evaluate the efficacy and safety of CKD-391 and CKD-331 in patients with primary hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:Adults ≥ 19 years of agePrimary hypercholesterolemiaPatients willing and able to discontinue ongoing lipid-lowering therapy according to the opinion of the investigatorExclusion Criteria:Secondary hypercholesterolemiaConditions / situations such as:Presence of any clinically significant uncontrolled endocrine/metabolic disease known to influence lipids levelsSevere renal impairment or active liver diseaseHistory of hypersensitivity or allergies to investigational drugs or drug of similar chemical classes.History of drug abuse or alcoholism within 24 weeks before screeningAny surgical or medical condition which might significantly affect the absorption, distribution, metabolism, or excretion of investigational drugsPatients who have been taken with other investigational drugs within 8 weeks before screening
Source: ClinicalTrials.gov (NCT05657574). StuddyBuddy aggregates publicly available trial information.