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

December 12, 2022 updated by: Chong Kun Dang Pharmaceutical

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

228

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CKD-391
D377 + CKD-331 + placebo (for D086)
Drug: D377
oral, once daily, 8 weeks
Drug: CKD-331
oral, once daily, 8 weeks
Drug: Placebo (for D086)
oral, once daily, 8 weeks
Active Comparator: CKD-331
CKD-331 + placebo (for D377) + placebo (for D086)
Drug: CKD-331
oral, once daily, 8 weeks
Drug: Placebo (for D086)
oral, once daily, 8 weeks
Drug: Placebo (for D377)
oral, once daily, 8 weeks
Active Comparator: D377
D377 + placebo (for CKD-331) + placebo (for D086)
Drug: D377
oral, once daily, 8 weeks
Drug: Placebo (for D086)
oral, once daily, 8 weeks
Drug: Placebo (for CKD-331)
oral, once daily, 8 weeks
Active Comparator: D086
D086 + placebo (for D377) + placebo (for CKD-331)
Drug: Placebo (for D377)
oral, once daily, 8 weeks
Drug: Placebo (for CKD-331)
oral, once daily, 8 weeks
Drug: D086
oral, once daily, 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change
Time Frame: Baseline, Week 8
from Baseline at Week 8 of Low Density Lipoprotein Cholesterol (LDL-C)
Baseline, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: SeungHwan Lee, MD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

December 12, 2022

First Submitted That Met QC Criteria

December 12, 2022

First Posted (Estimate)

December 20, 2022

Study Record Updates

Last Update Posted (Estimate)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A52_08HCL2217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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