Hypercholesterolemia, DyslipidemiaPhase 3NCT05970679
Clinical Trial to Evaluate the Efficacy and Safety of DW1125 and DW1125A
A Phase 3 study testing Ezetimibe/Atorvastatin 10/5 mg, Atorvastatin 5mg and Ezetimibe 10mg in people with Hypercholesterolemia, Dyslipidemia, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypercholesterolemia, Dyslipidemia
- What is being tested?
- Ezetimibe/Atorvastatin 10/5 mg, Atorvastatin 5mg and Ezetimibe 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Aug 2022to 13 Apr 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Hypercholesterolemia, Dyslipidemia
- Being tested
- Ezetimibe/Atorvastatin 10/5 mg, Atorvastatin 5mg, Ezetimibe 10mg, Atorvastatin 10mg, DW1125 placebo
- Medical subject headings
- Hypercholesterolemia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe/Atorvastatin 10/5 mgDrug
DW1125
Atorvastatin 5mgDrug
DW1125A
Ezetimibe 10mgDrug
Also called Ezetrol Tab. 10mg
DW1125E
Atorvastatin 10mgDrug
Also called Lipiwon Tab. 10mg
DW1125A-1
DW1125 placeboDrug
Ezetimibe/Atorvastatin 10/5 mg placebo
DW1125A placeboDrug
Atorvastatin 5mg placebo
DW1125E placeboDrug
Ezetimibe 10mg placebo
DW1125A-1 placeboDrug
Atorvastatin 10mg placebo
| Study group | Role | What they receive |
|---|---|---|
| DW1125 | Experimental | 1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily Receives: Drug: Ezetimibe/Atorvastatin 10/5 mg; Drug: DW1125A placebo; Drug: DW1125E placebo; Drug: DW1125A-1 placebo |
| DW1125A | Experimental | 1 Atorvastatin 5 mg tablet orally once daily Receives: Drug: Atorvastatin 5mg; Drug: DW1125 placebo; Drug: DW1125E placebo; Drug: DW1125A-1 placebo |
| DW1125E | Placebo comparator | 1 Ezetimibe 10mg tablet orally once daily Receives: Drug: Ezetimibe 10mg; Drug: DW1125 placebo; Drug: DW1125A placebo; Drug: DW1125A-1 placebo |
| DW1125A-1 | Placebo comparator | 1 Atorvastatin 10mg tablet orally once daily Receives: Drug: Atorvastatin 10mg; Drug: DW1125 placebo; Drug: DW1125A placebo; Drug: DW1125E placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Change of LDL-C
% Change of LDL-C in week 8 from baseline
Measured: 8 weeks
Secondary outcomes (3)
% Change of LDL-C
% Change of LDL-C in week 4 from baseline
Measured: 4 weeks
% 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
Measured: 4 weeks and 8 weeks
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)
Measured: 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start17 Aug 2022
- Primary completion13 Apr 2023
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercholesterolemia, DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970679
- Sponsor's protocol ID
- DW1125-301
- Status last verified
- Jul 2023
- First submitted
- 24 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05970679
- Acronym / sponsor ID
- DW1125-301
- Conditions
- Hypercholesterolemia, Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 13 Apr 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DW1125 | Experimental | Drug: Ezetimibe/Atorvastatin 10/5 mg, Drug: DW1125A placebo, Drug: DW1125E placebo, Drug: DW1125A-1 placebo1 Ezetimibe/Atorvastatin 10/5 mg tablet orally once daily |
| DW1125A | Experimental | Drug: Atorvastatin 5mg, Drug: DW1125 placebo, Drug: DW1125E placebo, Drug: DW1125A-1 placebo1 Atorvastatin 5 mg tablet orally once daily |
| DW1125E | Placebo comparator | Drug: Ezetimibe 10mg, Drug: DW1125 placebo, Drug: DW1125A placebo, Drug: DW1125A-1 placebo1 Ezetimibe 10mg tablet orally once daily |
| DW1125A-1 | Placebo comparator | Drug: Atorvastatin 10mg, Drug: DW1125 placebo, Drug: DW1125A placebo, Drug: DW1125E placebo1 Atorvastatin 10mg tablet orally once daily |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ezetimibe/Atorvastatin 10/5 mgDW1125 | Drug | DW1125 |
| Atorvastatin 5mgDW1125A | Drug | DW1125A |
| Ezetimibe 10mgAlso: Ezetrol Tab. 10mgDW1125E | Drug | DW1125E |
| Atorvastatin 10mgAlso: Lipiwon Tab. 10mgDW1125A-1 | Drug | DW1125A-1 |
| DW1125 placeboEzetimibe/Atorvastatin 10/5 mg placebo | Drug | DW1125A, DW1125A-1, DW1125E |
| DW1125A placeboAtorvastatin 5mg placebo | Drug | DW1125, DW1125A-1, DW1125E |
| DW1125E placeboEzetimibe 10mg placebo | Drug | DW1125, DW1125A, DW1125A-1 |
| DW1125A-1 placeboAtorvastatin 10mg placebo | Drug | DW1125, DW1125A, DW1125E |
Primary outcome
% Change of LDL-C
Time frame: 8 weeks
% Change of LDL-C in week 8 from baseline
3 secondary outcomes
% Change of LDL-C
Time frame: 4 weeks
% Change of Lipid parameters
Time frame: 4 weeks and 8 weeks
LDL-C goal achievement rates
Time frame: 4 weeks and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ezetimibe/Atorvastatin 10/5 mg, Atorvastatin 5mg and Ezetimibe 10mg in people with Hypercholesterolemia, Dyslipidemia, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% Change of LDL-C (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.