Back to resultsA Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia
Primary Purpose
Primary Hypercholesterolemia
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
D377
CKD-331
D086
Placebo (for D377)
Placebo (for CKD-331)
Placebo (for D086)
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypercholesterolemia
Eligibility Criteria
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: 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
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
CKD-391
CKD-331
D377
D086
Arm Description
D377 + CKD-331 + placebo (for D086)
CKD-331 + placebo (for D377) + placebo (for D086)
D377 + placebo (for CKD-331) + placebo (for D086)
D086 + placebo (for D377) + placebo (for CKD-331)
Outcomes
Primary Outcome Measures
Percent Change
from Baseline at Week 8 of Low Density Lipoprotein Cholesterol (LDL-C)
Secondary Outcome Measures
Full Information
NCT ID
NCT05657574
First Posted
December 12, 2022
Last Updated
December 12, 2022
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT05657574
Brief Title
A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
228 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CKD-391
Arm Type
Experimental
Arm Description
D377 + CKD-331 + placebo (for D086)
Arm Title
CKD-331
Arm Type
Active Comparator
Arm Description
CKD-331 + placebo (for D377) + placebo (for D086)
Arm Title
D377
Arm Type
Active Comparator
Arm Description
D377 + placebo (for CKD-331) + placebo (for D086)
Arm Title
D086
Arm Type
Active Comparator
Arm Description
D086 + placebo (for D377) + placebo (for CKD-331)
Intervention Type
Drug
Intervention Name(s)
D377
Intervention Description
oral, once daily, 8 weeks
Intervention Type
Drug
Intervention Name(s)
CKD-331
Intervention Description
oral, once daily, 8 weeks
Intervention Type
Drug
Intervention Name(s)
D086
Intervention Description
oral, once daily, 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo (for D377)
Intervention Description
oral, once daily, 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo (for CKD-331)
Intervention Description
oral, once daily, 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo (for D086)
Intervention Description
oral, once daily, 8 weeks
Primary Outcome Measure Information:
Title
Percent Change
Description
from Baseline at Week 8 of Low Density Lipoprotein Cholesterol (LDL-C)
Time Frame
Baseline, Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SeungHwan Lee, MD
Phone
+82-2-3010-4829
Email
seungwlee@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SeungHwan Lee, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SeungHwan Lee, MD
Phone
+82-2-3010-4829
Email
seungwlee@amc.seoul.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia
We'll reach out to this number within 24 hrs