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

NCT05657574 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2022-12-20

No results posted yet for this 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

Conditions

  • Primary Hypercholesterolemia

Interventions

DRUG

D377

oral, once daily, 8 weeks

DRUG

CKD-331

oral, once daily, 8 weeks

DRUG

D086

oral, once daily, 8 weeks

DRUG

Placebo (for D377)

oral, once daily, 8 weeks

DRUG

Placebo (for CKD-331)

oral, once daily, 8 weeks

DRUG

Placebo (for D086)

oral, once daily, 8 weeks

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • SeungHwan Lee, MD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-24
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05657574 on ClinicalTrials.gov