Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507

Daewoong Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Dyslipidemias

Treatments: Drug: DWJ1507; Drug: DWJ1177; Drug: DWJ1506; Drug: DWC202011

Study type: Interventional

Funder types: Industry

Identifiers

NCT04772443

DW_DWJ1507301

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of DWJ1506 and DWJ1507 in the patients with dyslipidemia.

Enrollment: 280 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 19 years or over
2. Patients with LDL-C levels ≤ 250 mg/dL, TG < 500 mg/dL
3. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Exclusion criteria

1. Severe congestive hear failure
2. Current active liver disease
3. The use of prohibiterd concomitant therapies
4. Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc.

6.Women who were of childbearing potential without contraception, pregnant, or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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280 participants in 4 patient groups

DWJ1506

Experimental group

Treatment:

Drug: DWJ1506

DWJ1507

Experimental group

Treatment:

Drug: DWJ1507

DWC202011

Active Comparator group

Treatment:

Drug: DWC202011

DWJ1177

Active Comparator group

Treatment:

Drug: DWJ1177