Phase 3 Trial to Evaluate the Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A

Sponsor

Dongkwang Pharm. Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05809687

Collaborator

(none)

512

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Phase 3 study to evaluate the efficacy and safety of DKP21102_B Added on to DKP21102_A Compared with DKP21102_A

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemias	Drug: DKP21102_C Drug: DKP21102_B Drug: DKP21102_A	Phase 3

Detailed Description

Phase 3 study to evaluate the efficacy and safety of DKP21102 in patients with mixed dyslipidemia where LDL-C is properly controlled but triglyceride and HDL-C levels are not regulated by DKP21102_A alone.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

512 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double-blind

Primary Purpose:

Treatment

Official Title:

Evaluate Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A in Mixed Dyslipidemia Patients

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group DKP21102_A, DKP21102_C	Drug: DKP21102_C Placebo Drug: DKP21102_A Active Control
Experimental: Treatment group DKP21102_A, DKP21102_B	Drug: DKP21102_B Treatment Drug: DKP21102_A Active Control

Arm

Intervention/Treatment

Active Comparator: Control group

DKP21102_A, DKP21102_C

Drug: DKP21102_C

Placebo

Drug: DKP21102_A

Active Control

Experimental: Treatment group

DKP21102_A, DKP21102_B

Drug: DKP21102_B

Treatment

Drug: DKP21102_A

Active Control

Outcome Measures

Primary Outcome Measures

Percent change (%) of non-HDL-C from baseline [from baseline at 12weeks]
non-HDL-C

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A man or woman over 19 years old.
Patients with coronary heart disease or risk of coronary heart disease

Exclusion Criteria:

History of Unstable angina, myocardial infarction etc
Uncontrolled hypo-thyroidism (TSH≥1.5XULN), Diabetes(HbA1c ≥ 9.0%)
renal impairment (Creatinine clearance < 60 mL/min) etc.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Dongkwang Pharm. Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dongkwang Pharm. Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05809687

Other Study ID Numbers:

DKP21102_301

First Posted:

Apr 12, 2023

Last Update Posted:

Apr 14, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dyslipidemias

Study Results

No Results Posted as of Apr 14, 2023