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

Phase 3

Recruiting

• Conditions: Primary Hypercholesterolemia
• Interventions: Drug: D086; Drug: D377; Drug: Placebo (for CKD-331); Drug: CKD-331; Drug: Placebo (for D377); Drug: Placebo (for D086)

• Registration Number: NCT05657574
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief 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.

Study Timeline

• Study Start: 2022-11-24
• Status Verified: 2022-12
• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-12
• Last Update Submitted: 2022-12-12
• Study First Posted: 2022-12-20
• Last Update Posted: 2022-12-20
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 228

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D377	Placebo (for D086)	D377 + placebo (for CKD-331) + placebo (for D086)
D086	D086	D086 + placebo (for D377) + placebo (for CKD-331)
CKD-331	Placebo (for D086)	CKD-331 + placebo (for D377) + placebo (for D086)
D377	Placebo (for CKD-331)	D377 + placebo (for CKD-331) + placebo (for D086)
CKD-391	CKD-331	D377 + CKD-331 + placebo (for D086)
CKD-331	CKD-331	CKD-331 + placebo (for D377) + placebo (for D086)
CKD-391	D377	D377 + CKD-331 + placebo (for D086)
CKD-391	Placebo (for D086)	D377 + CKD-331 + placebo (for D086)
CKD-331	Placebo (for D377)	CKD-331 + placebo (for D377) + placebo (for D086)
D377	D377	D377 + placebo (for CKD-331) + placebo (for D086)
D086	Placebo (for CKD-331)	D086 + placebo (for D377) + placebo (for CKD-331)
D086	Placebo (for D377)	D086 + placebo (for D377) + placebo (for CKD-331)

Primary Outcome Measures

Name	Time	Method
Percent Change	Baseline, Week 8	from Baseline at Week 8 of Low Density Lipoprotein Cholesterol (LDL-C)

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of