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

Dongkwang Pharm. Co., Ltd.

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Dyslipidemias

Interventions

DKP21102_CDRUG

Placebo

DKP21102_BDRUG

Treatment

DKP21102_ADRUG

Active Control

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

non-HDL-C

Time frame: from baseline at 12weeks

Data from ClinicalTrials.gov

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