NCT05657574

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Primary Hypercholesterolemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-11-24
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2022-12-20
• Last updated: 2022-12-20

Locations

1 site across 1 country: South Korea