A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia

Last updated: December 12, 2022
Sponsor: Chong Kun Dang Pharmaceutical
Overall Status: Active - Recruiting

Phase

3

Condition

Hypercholesterolemia

Familial Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT05657574
A52_08HCL2217
  • Ages > 19
  • All Genders

Study 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

Inclusion Criteria:

  • Adults ≥ 19 years of age
  • Primary hypercholesterolemia
  • Patients willing and able to discontinue ongoing lipid-lowering therapy according tothe opinion of the investigator

Exclusion

Exclusion Criteria:

  • Secondary hypercholesterolemia
  • Conditions / situations such as:
  1. Presence of any clinically significant uncontrolled endocrine/metabolic diseaseknown to influence lipids levels
  2. Severe renal impairment or active liver disease
  • History of hypersensitivity or allergies to investigational drugs or drug of similarchemical classes.
  • History of drug abuse or alcoholism within 24 weeks before screening
  • Any surgical or medical condition which might significantly affect the absorption,distribution, metabolism, or excretion of investigational drugs
  • Patients who have been taken with other investigational drugs within 8 weeks beforescreening

Study Design

Total Participants: 228
Study Start date:
November 24, 2022
Estimated Completion Date:
June 30, 2023

Study Description

Participants were randomly assigned in a 1:1:1:1 ratio to the following groups: combination therapy of D377 and CKD-331, D377, CKD-331, and D086. The patients are prescribed oral administration of the appropriate IP daily (3 tablets: actual medication and placebo) for 8 weeks.

Connect with a study center

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

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