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Clinical Trials/NCT05809687
NCT05809687WithdrawnPhase 3

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

Dongkwang Pharm. Co., Ltd.0 sites512 target enrollmentStarted: January 1, 2025Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Withdrawn
Enrollment
512
Primary Endpoint
Percent change (%) of non-HDL-C from baseline
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

Double-blind

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Control group

Active Comparator

DKP21102_A, DKP21102_C

Intervention: DKP21102_C (Drug)

Control group

Active Comparator

DKP21102_A, DKP21102_C

Intervention: DKP21102_A (Drug)

Treatment group

Experimental

DKP21102_A, DKP21102_B

Intervention: DKP21102_B (Drug)

Treatment group

Experimental

DKP21102_A, DKP21102_B

Intervention: DKP21102_A (Drug)

Outcomes

Primary Outcomes

Percent change (%) of non-HDL-C from baseline

Time Frame: from baseline at 12weeks

non-HDL-C

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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