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

Phase 3 Unknown 228 enrolled Chong Kun Dang Pharmaceutical

RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start: 2022-11-24
Primary completion: 2023-06
Completion: 2023-06

Publications

Kim TO, Lee K, Cho JM, Yoon HJ, Park TH, Choi JH, Suh JW, Kim SY, Lim HS, Park JS, Cho DK, Park GM, Ahn SG, Shin S, Kwon SU, Kim DH, Lee SR, Sung JH, Park HC, Lee SW. Efficacy and safety of low-dose atorvastatin plus ezetimibe for primary hypercholesterolemia: A randomized, double-blind, multicenter phase 3 trial. Lipids. 2025 Sep;60(5):317-326. doi: 10.1002/lipd.12442. Epub 2025 Apr 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atorvastatin	Small molecule	5 mg	Oral
Subject	Atorvastatin	Small molecule	10 mg	Oral
Subject	Ezetimibe	Unknown	10 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications