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Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A

Primary Purpose

Hypercholesterolemia, Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ezetimibe/Atorvastatin 10/5 mg
Atorvastatin 5mg
Ezetimibe 10mg
Atorvastatin 10mg
DW1125 placebo
DW1125A placebo
DW1125E placebo
DW1125A-1 placebo
Sponsored by
Daewon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia, Dyslipidemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Both gender, the person aged 19 or older Patients who are diagnosed with primary Hypercholesterolemia or Mixed Dyslipidemia LDL- C ≤ 250 mg/dL and TG < 500 mg/dL on fasting status Exclusion Criteria: Patients with Myopathy, Rhabdomyolysis, Fibromyalgia, hereditary neuromuscular disorders or family history, or Creatine kinase(CK) ≥ 2 x Upper Limit of Normal(ULN) on Visit 1 Patients with severe renal disorders, Estimated Flomerular Filtration Rate (eGFR) < 30 mL/min/1.73m^2 on Visit 1 Patients with hepatic failure or active or chronic hepatobiliary diseases or aspartate transaminase (AST) or alanine aminotransferase (ALT) ≥ 2.0 x ULN on visit 1

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

DW1125

DW1125A

DW1125E

DW1125A-1

Arm Description

1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily

1 Atorvastatin 5 mg tablet orally once daily

1 Ezetimibe 10mg tablet orally once daily

1 Atorvastatin 10mg tablet orally once daily

Outcomes

Primary Outcome Measures

% Change of LDL-C
% Change of LDL-C in week 8 from baseline

Secondary Outcome Measures

% Change of LDL-C
% Change of LDL-C in week 4 from baseline
% Change of Lipid parameters
% Change of Lipid parameters(TC, TG, HDL-C, Non-HDL-C, Apo A1, Apo B) in week 4 and week 8 respectively after administrating the treatment drugs
LDL-C goal achievement rates
LDL-C goal achievement rates in week 4 and week 8 respectively after administrating the treatment drugs (goal achievement for LDL-C: low risk group: < 160 mg/dL, intermediate risk group: <130 mg/dL, high risk group: < 100 mg/dL, extreme risk group: < 70 mg/dL)

Full Information

First Posted
July 24, 2023
Last Updated
July 24, 2023
Sponsor
Daewon Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05970679
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A
Official Title
A Randomized, Double Blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient With Primary Hypercholesterolemia or Mixed Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
April 13, 2023 (Actual)
Study Completion Date
April 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Randomized, Double blind, Parallel, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A in Patient with primary Hypercholesterolemia or Mixed Dyslipidemia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DW1125
Arm Type
Experimental
Arm Description
1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily
Arm Title
DW1125A
Arm Type
Experimental
Arm Description
1 Atorvastatin 5 mg tablet orally once daily
Arm Title
DW1125E
Arm Type
Placebo Comparator
Arm Description
1 Ezetimibe 10mg tablet orally once daily
Arm Title
DW1125A-1
Arm Type
Placebo Comparator
Arm Description
1 Atorvastatin 10mg tablet orally once daily
Intervention Type
Drug
Intervention Name(s)
Ezetimibe/Atorvastatin 10/5 mg
Intervention Description
DW1125
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 5mg
Intervention Description
DW1125A
Intervention Type
Drug
Intervention Name(s)
Ezetimibe 10mg
Other Intervention Name(s)
Ezetrol Tab. 10mg
Intervention Description
DW1125E
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 10mg
Other Intervention Name(s)
Lipiwon Tab. 10mg
Intervention Description
DW1125A-1
Intervention Type
Drug
Intervention Name(s)
DW1125 placebo
Intervention Description
Ezetimibe/Atorvastatin 10/5 mg placebo
Intervention Type
Drug
Intervention Name(s)
DW1125A placebo
Intervention Description
Atorvastatin 5mg placebo
Intervention Type
Drug
Intervention Name(s)
DW1125E placebo
Intervention Description
Ezetimibe 10mg placebo
Intervention Type
Drug
Intervention Name(s)
DW1125A-1 placebo
Intervention Description
Atorvastatin 10mg placebo
Primary Outcome Measure Information:
Title
% Change of LDL-C
Description
% Change of LDL-C in week 8 from baseline
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
% Change of LDL-C
Description
% Change of LDL-C in week 4 from baseline
Time Frame
4 weeks
Title
% Change of Lipid parameters
Description
% Change of Lipid parameters(TC, TG, HDL-C, Non-HDL-C, Apo A1, Apo B) in week 4 and week 8 respectively after administrating the treatment drugs
Time Frame
4 weeks and 8 weeks
Title
LDL-C goal achievement rates
Description
LDL-C goal achievement rates in week 4 and week 8 respectively after administrating the treatment drugs (goal achievement for LDL-C: low risk group: < 160 mg/dL, intermediate risk group: <130 mg/dL, high risk group: < 100 mg/dL, extreme risk group: < 70 mg/dL)
Time Frame
4 weeks and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both gender, the person aged 19 or older Patients who are diagnosed with primary Hypercholesterolemia or Mixed Dyslipidemia LDL- C ≤ 250 mg/dL and TG < 500 mg/dL on fasting status Exclusion Criteria: Patients with Myopathy, Rhabdomyolysis, Fibromyalgia, hereditary neuromuscular disorders or family history, or Creatine kinase(CK) ≥ 2 x Upper Limit of Normal(ULN) on Visit 1 Patients with severe renal disorders, Estimated Flomerular Filtration Rate (eGFR) < 30 mL/min/1.73m^2 on Visit 1 Patients with hepatic failure or active or chronic hepatobiliary diseases or aspartate transaminase (AST) or alanine aminotransferase (ALT) ≥ 2.0 x ULN on visit 1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A

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