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

NCT05657574 | Unknown Phase 3

• 1 other identifier: A52_08HCL2217
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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

Conditions

Primary Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percent Change

  from Baseline at Week 8 of Low Density Lipoprotein Cholesterol (LDL-C)

  Baseline, Week 8

Study Arms (4)

CKD-391

EXPERIMENTAL

D377 + CKD-331 + placebo (for D086)

Drug: D377; Drug: CKD-331; Drug: Placebo (for D086)

CKD-331

ACTIVE COMPARATOR

CKD-331 + placebo (for D377) + placebo (for D086)

Drug: CKD-331; Drug: Placebo (for D377); Drug: Placebo (for D086)

D377

ACTIVE COMPARATOR

D377 + placebo (for CKD-331) + placebo (for D086)

Drug: D377; Drug: Placebo (for CKD-331); Drug: Placebo (for D086)

D086

ACTIVE COMPARATOR

D086 + placebo (for D377) + placebo (for CKD-331)

Drug: D086; Drug: Placebo (for D377); Drug: Placebo (for CKD-331)

Interventions

D377 DRUG

oral, once daily, 8 weeks

CKD-391; D377

CKD-331 DRUG

oral, once daily, 8 weeks

CKD-331; CKD-391

D086 DRUG

oral, once daily, 8 weeks

D086

Placebo (for D377) DRUG

oral, once daily, 8 weeks

CKD-331; D086

Placebo (for CKD-331) DRUG

oral, once daily, 8 weeks

D086; D377

Placebo (for D086) DRUG

oral, once daily, 8 weeks

CKD-331; CKD-391; D377

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 19 years of age
• Primary hypercholesterolemia
• Patients willing and able to discontinue ongoing lipid-lowering therapy according to the opinion of the investigator

You may not qualify if:

• Secondary hypercholesterolemia
• Conditions / situations such as:
• Presence of any clinically significant uncontrolled endocrine/metabolic disease known to influence lipids levels
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Study Officials

• SeungHwan Lee, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SeungHwan Lee, MD

CONTACT

+82-2-3010-4829; seungwlee@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 20, 2022
• Study Start: November 24, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)