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NCT04772443 Clinical Trial

Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507

Dyslipidemias Clinical Trial

Official title:
A Randomized, Double-blind, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04772443
Other study ID # DW_DWJ1507301
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date February 2021
Est. completion date December 2022

Study information
Verified date February 2021
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 280
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DWJ1506
DWJ1506
• DWJ1507
DWJ1507
• DWC202011
DWC202011
• DWJ1177
DWC202011

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Outcome
Type Measure Description Time frame Safety issue
Primary LDL-C levels at week 8 Change from baseline in LDL-C level at week 8 after administration of the IP Week 8
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