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

Dongkwang Pharm.

Status and phase: Withdrawn; Phase 3

Conditions: Dyslipidemias

Treatments: Drug: DKP21102_A; Drug: DKP21102_B; Drug: DKP21102_C

Study type: Interventional

Funder types: Industry

Identifiers

NCT05809687

DKP21102_301

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 19+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Control group

Active Comparator group

Description:

DKP21102_A, DKP21102_C

Treatment:

Drug: DKP21102_C

Drug: DKP21102_A

Treatment group

Experimental group

Description:

DKP21102_A, DKP21102_B

Treatment:

Drug: DKP21102_B

Drug: DKP21102_A