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

Primary Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05657574
• Other study ID #: A52_08HCL2217
• Status: Recruiting
• Phase: Phase 3
• Start date: November 24, 2022
• Est. completion date: June 2023

Study information

• Verified date: December 2022
• Source: Chong Kun Dang Pharmaceutical
• Contact: SeungHwan Lee, MD
• Phone: +82-2-3010-4829
• Email: seungwlee[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Primary Hypercholesterolemia

Intervention

Drug:
• D377
oral, once daily, 8 weeks
• CKD-331
oral, once daily, 8 weeks
• D086
oral, once daily, 8 weeks
• Placebo (for D377)
oral, once daily, 8 weeks
• Placebo (for CKD-331)
oral, once daily, 8 weeks
• Placebo (for D086)
oral, once daily, 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change	from Baseline at Week 8 of Low Density Lipoprotein Cholesterol (LDL-C)	Baseline, Week 8