DyslipidemiasNCT05889143
A Study to Evaluate the Efficacy and Safety of CREZET Tablet
An observational study of Dyslipidemias, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This observation study is to evaluate blood lipid-lowering effects and liver/renal safety, changes in HbA1c and FPG in patients with dyslipidemia who administered CREZET tablets for 24 weeks. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Ezetimibe/Rosuvastatin
- Type of treatment
- Pill or oral medicine
- How many people
- 15,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 May 2023to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The number of test subjects was calculated using the confidence interval of the rate of change, noting that the primary purpose of this observation study was to evaluate the rate of change in a single group. Recruitment of 14,151 people, which is 1.5%, was expected by referring to the minimum number of subjects required and the estimated patients taking two components of single drug and ezetimib compound. However, this study was a non-intervention observation study conducted under daily treatment, and it was confirmed that the number of subjects who applied 10% of the dropout rate was about 15,000 Therefore, this study will be conducted with study population of 15,000 subjects.
Who may be able to join
- an adult male and female over 19 years of age
- A patient with dyslipidemia who is scheduled to administer Crezet tablets according to the medical judgment of the investigator based on permission
- A person who voluntarily participates in the observational study and agrees in writing to comply with the subject's precautions during the study period after hearing and understanding the detailed explanation of the characteristics of the observational study and the drug to be studied
Who cannot join
- A person who is prohibited from administering according to the permission of the Crezet definition
- Patients who overreact to the principal or component of the Crezet definition
- Patients with active liver disease or patients with persistent high symptoms of serum aminotransferase levels
- a patient with a muscle disease
- a patient administered in combination with a cyclosporine-med
- Patients with severe renal failure (Creatinine Clearance (CLcr) < 30 mL/min)
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- Women and lactating women who may be pregnant or pregnant
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- A person who has a history of taking Crezet tablets within three months of the date of registration
- A person who is deemed inappropriate to participate in this observational study based on the judgment of investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Non-Intervention, Multi-Center Observational Study to Evaluate the Efficacy and Safety of CREZET Tablet in Patients With Dyslipidemia
This observation study is to evaluate blood lipid-lowering effects and liver/renal safety, changes in HbA1c and FPG in patients with dyslipidemia who administered CREZET tablets for 24 weeks.
Read the detailed description
A subject who is diagnosed with dyslipidemia and scheduled to administer CREZET tablets, will be enrolled in this study based on the doctor's medical decision.
The CREZET Tablet will be administered for 24 weeks, and the data including demographic information, body measurement, vital signs and etc will be collected during the study period.
The data collection point is as follows.
- Visit 1 (baseline, day 0)
- Visit 2 (at 12 weeks)
- Visit 3 (at 24 weeks)
- Conditions
- Dyslipidemias
- Being tested
- Ezetimibe/Rosuvastatin
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe/RosuvastatinDrug
Also called Crezet Tablet
Patient treated with Crezet Tablet
| Study group | Role | What they receive |
|---|---|---|
| Mucotra® SR Tab | Not described Receives: Drug: Ezetimibe/Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of change in LDL-C
The Rate of change in LDL-C at 24 weeks from baseline
Measured: 24 weeks
Secondary outcomes (13)
The Rate of change in LDL-C
The Rate of change in LDL-C at 12 weeks from baseline
Measured: 12 weeks
The change in HbA1c
The change in HbA1c at 12 weeks from baseline
Measured: 12 weeks
The change in HbA1c
The change in HbA1c at 24 weeks from baseline
Measured: 24 weeks
The change in FPG
The change in FPG at 12 weeks from baseline
Measured: 12 weeks
The change in FPG
The change in FPG at 24 weeks from baseline
Measured: 24 weeks
The chanage in lipid variable
The chanage in lipid variable at 12 weeks from baseline
Measured: 12 weeks
The chanage in lipid variable
The chanage in lipid variable at 24 weeks from baseline
Measured: 24 weeks
The change in AST
The change in AST at 12 weeks from baseline
Measured: 12 weeks
The change in AST
The change in AST at 24 weeks from baseline
Measured: 24 weeks
The change in ALT
The change in ALT at 12 weeks from baseline
Measured: 12 weeks
The change in ALT
The change in ALT at 24 weeks from baseline
Measured: 24 weeks
Percentage of subjects who reached LDL-C target
Percentage of subjects who reached LDL-C target according to Korean Society of Lipid Arteriosclerosis's risk classification of treatment guidelines for dyslipidemia at 12 weeks from baseline
Measured: 12 weeks
Percentage of subjects who reached LDL-C target
Percentage of subjects who reached LDL-C target according to Korean Society of Lipid Arteriosclerosis's risk classification of treatment guidelines for dyslipidemia at 24 weeks from baseline
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start24 May 2023
- Primary completion31 Dec 2024
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JunYoung Park, Study director, Daewoong Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889143
- Sponsor's protocol ID
- DWCRZ_OS_01
- Status last verified
- Aug 2025
- First submitted
- 25 May 2023
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided at this point
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Intervention, Multi-Center Observational Study to Evaluate the Efficacy and Safety of CREZET Tablet in Patients With Dyslipidemia
- ClinicalTrials.gov ID
- NCT05889143
- Acronym / sponsor ID
- DWCRZ_OS_01
- Conditions
- Dyslipidemias
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 24 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 5 Jun 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.
This observation study is to evaluate blood lipid-lowering effects and liver/renal safety, changes in HbA1c and FPG in patients with dyslipidemia who administered CREZET tablets for 24 weeks.
Detailed description
A subject who is diagnosed with dyslipidemia and scheduled to administer CREZET tablets, will be enrolled in this study based on the doctor's medical decision.
The CREZET Tablet will be administered for 24 weeks, and the data including demographic information, body measurement, vital signs and etc will be collected during the study period.
The data collection point is as follows.
- Visit 1 (baseline, day 0)
- Visit 2 (at 12 weeks)
- Visit 3 (at 24 weeks)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mucotra® SR Tab | – | Drug: Ezetimibe/Rosuvastatin |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The number of test subjects was calculated using the confidence interval of the rate of change, noting that the primary purpose of this observation study was to evaluate the rate of change in a single group. Recruitment of 14,151 people, which is 1.5%, was expected by referring to the minimum number of subjects required and the estimated patients taking two components of single drug and ezetimib compound. However, this study was a non-intervention observation study conducted under daily treatment, and it was confirmed that the number of subjects who applied 10% of the dropout rate was about 15,000 Therefore, this study will be conducted with study population of 15,000 subjects.
Key inclusion criteria (3 listed)
- an adult male and female over 19 years of age
- A patient with dyslipidemia who is scheduled to administer Crezet tablets according to the medical judgment of the investigator based on permission
- A person who voluntarily participates in the observational study and agrees in writing to comply with the subject's precautions during the study period after hearing and understanding the detailed explanation of the characteristics of the observational study and the drug to be studied
Key exclusion criteria (10 listed)
- A person who is prohibited from administering according to the permission of the Crezet definition
- A person who has a history of taking Crezet tablets within three months of the date of registration
- A person who is deemed inappropriate to participate in this observational study based on the judgment of investigator.
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/RosuvastatinAlso: Crezet TabletPatient treated with Crezet Tablet | Drug | Mucotra® SR Tab |
Primary outcome
The Rate of change in LDL-C
Time frame: 24 weeks
The Rate of change in LDL-C at 24 weeks from baseline
13 secondary outcomes
The Rate of change in LDL-C
Time frame: 12 weeks
The change in HbA1c
Time frame: 12 weeks
The change in HbA1c
Time frame: 24 weeks
The change in FPG
Time frame: 12 weeks
The change in FPG
Time frame: 24 weeks
The chanage in lipid variable
Time frame: 12 weeks
The chanage in lipid variable
Time frame: 24 weeks
The change in AST
Time frame: 12 weeks
The change in AST
Time frame: 24 weeks
The change in ALT
Time frame: 12 weeks
The change in ALT
Time frame: 24 weeks
Percentage of subjects who reached LDL-C target
Time frame: 12 weeks
Percentage of subjects who reached LDL-C target
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Undecided. Undecided at this point
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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.
JunYoung Park study director
Daewoong Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemias, run by Daewoong 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 10 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
The Rate of change in LDL-C (time frame: 24 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 24 Aug 2025.