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A

Asan Medical Center | Clinical Trial Center

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

C

Chong Kun Dang

Status and phase

Enrolling
Phase 3

Conditions

Primary Hypercholesterolemia

Treatments

Drug: Placebo (for CKD-331)
Drug: CKD-331
Drug: D377
Drug: D086
Drug: Placebo (for D086)
Drug: Placebo (for D377)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05657574
A52_08HCL2217

Details and patient eligibility

About

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

Full 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.

Enrollment

228 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Secondary hypercholesterolemia

  • Conditions / situations such as:

    1. Presence of any clinically significant uncontrolled endocrine/metabolic disease known to influence lipids levels
    2. Severe renal impairment or active liver disease
  • History of hypersensitivity or allergies to investigational drugs or drug of similar chemical 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 before screening

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

228 participants in 4 patient groups

CKD-391
Experimental group
Description:
D377 + CKD-331 + placebo (for D086)
Treatment:
Drug: Placebo (for D086)
Drug: CKD-331
Drug: D377
CKD-331
Active Comparator group
Description:
CKD-331 + placebo (for D377) + placebo (for D086)
Treatment:
Drug: Placebo (for D377)
Drug: Placebo (for D086)
Drug: CKD-331
D377
Active Comparator group
Description:
D377 + placebo (for CKD-331) + placebo (for D086)
Treatment:
Drug: Placebo (for D086)
Drug: D377
Drug: Placebo (for CKD-331)
D086
Active Comparator group
Description:
D086 + placebo (for D377) + placebo (for CKD-331)
Treatment:
Drug: Placebo (for D377)
Drug: D086
Drug: Placebo (for CKD-331)

Trial contacts and locations

1

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Central trial contact

SeungHwan Lee, MD

Data sourced from clinicaltrials.gov

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