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Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507

NCT ID: NCT04772443

Last Updated: 2021-02-26

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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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

Study Groups

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DWJ1506

Group Type EXPERIMENTAL

DWJ1506

Intervention Type DRUG

DWJ1506

DWJ1507

Group Type EXPERIMENTAL

DWJ1507

Intervention Type DRUG

DWJ1507

DWC202011

Group Type ACTIVE_COMPARATOR

DWC202011

Intervention Type DRUG

DWC202011

DWJ1177

Group Type ACTIVE_COMPARATOR

DWJ1177

Intervention Type DRUG

DWC202011

Interventions

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DWJ1506

DWJ1506

Intervention Type DRUG

DWJ1507

DWJ1507

Intervention Type DRUG

DWC202011

DWC202011

Intervention Type DRUG

DWJ1177

DWC202011

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DW_DWJ1507301

Identifier Type: -

Identifier Source: org_study_id