Phase 3 Trial to Evaluate the Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-12-01

Brief Summary

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Phase 3 study to evaluate the efficacy and safety of DKP21102\_B Added on to DKP21102\_A Compared with DKP21102\_A

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Detailed Description

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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.

Conditions

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Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind

Study Groups

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Control group

DKP21102\_A, DKP21102\_C

Group Type ACTIVE_COMPARATOR

DKP21102_C

Intervention Type DRUG

Placebo

DKP21102_A

Intervention Type DRUG

Active Control

Treatment group

DKP21102\_A, DKP21102\_B

Group Type EXPERIMENTAL

DKP21102_B

Intervention Type DRUG

Treatment

DKP21102_A

Intervention Type DRUG

Active Control

Interventions

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DKP21102_C

Placebo

Intervention Type DRUG

DKP21102_B

Treatment

Intervention Type DRUG

DKP21102_A

Active Control

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No