Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507
A Randomized, Double-blind, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507
1 other identifier
interventional
280
0 countries
N/A
Brief Summary
The purpose of this study is to determine the efficacy and safety of DWJ1506 and DWJ1507 in the patients with dyslipidemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 24, 2021
CompletedFirst Posted
Study publicly available on registry
February 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedFebruary 26, 2021
February 1, 2021
1.8 years
February 24, 2021
February 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
LDL-C levels at week 8
Change from baseline in LDL-C level at week 8 after administration of the IP
Week 8
Study Arms (4)
DWJ1506
EXPERIMENTALDWJ1507
EXPERIMENTALDWC202011
ACTIVE COMPARATORDWJ1177
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Adults aged 19 years or over
- Patients with LDL-C levels ≤ 250 mg/dL, TG \< 500 mg/dL
- Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study
You may not qualify if:
- Severe congestive hear failure
- Current active liver disease
- The use of prohibiterd concomitant therapies
- 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.
- Women who were of childbearing potential without contraception, pregnant, or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2021
First Posted
February 26, 2021
Study Start
February 1, 2021
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
February 26, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share