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Active, not recruitingNCT05889143Updated Aug 24, 2025

A Study to Evaluate the Efficacy and Safety of CREZET Tablet

An observational study in Dyslipidemias, sponsored by Daewoong Pharmaceutical Co. LTD.. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-08-24.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
15,000
Ages
19 Years and older
Sex
All
01

Study 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 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.

  1. Visit 1 (baseline, day 0)
  2. Visit 2 (at 12 weeks)
  3. Visit 3 (at 24 weeks)
02

Conditions studied

  • Dyslipidemias

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03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's planned enrollment of 15,000 is above the median of 600 across 204 observational studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  1. an adult male and female over 19 years of age
  2. A patient with dyslipidemia who is scheduled to administer Crezet tablets according to the medical judgment of the investigator based on permission
  3. 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

Exclusion criteria

Exclusion Criteria:

  1. 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)
    • 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
  2. A person who has a history of taking Crezet tablets within three months of the date of registration
  3. A person who is deemed inappropriate to participate in this observational study based on the judgment of investigator.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
15,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Mucotra® SR Tab

    Drug: Ezetimibe/Rosuvastatin

Interventions

  • DrugEzetimibe/Rosuvastatin

    Patient treated with Crezet Tablet

    Also known as: Crezet Tablet

06

What researchers measure

Primary outcomes

  1. The Rate of change in LDL-C

    The Rate of change in LDL-C at 24 weeks from baseline

    Time frame: 24 weeks

Secondary outcomes

  1. The Rate of change in LDL-C

    The Rate of change in LDL-C at 12 weeks from baseline

    Time frame: 12 weeks

  2. The change in HbA1c

    The change in HbA1c at 12 weeks from baseline

    Time frame: 12 weeks

  3. The change in HbA1c

    The change in HbA1c at 24 weeks from baseline

    Time frame: 24 weeks

  4. The change in FPG

    The change in FPG at 12 weeks from baseline

    Time frame: 12 weeks

  5. The change in FPG

    The change in FPG at 24 weeks from baseline

    Time frame: 24 weeks

  6. The chanage in lipid variable

    The chanage in lipid variable at 12 weeks from baseline

    Time frame: 12 weeks

  7. The chanage in lipid variable

    The chanage in lipid variable at 24 weeks from baseline

    Time frame: 24 weeks

  8. The change in AST

    The change in AST at 12 weeks from baseline

    Time frame: 12 weeks

  9. The change in AST

    The change in AST at 24 weeks from baseline

    Time frame: 24 weeks

  10. The change in ALT

    The change in ALT at 12 weeks from baseline

    Time frame: 12 weeks

  11. The change in ALT

    The change in ALT at 24 weeks from baseline

    Time frame: 24 weeks

  12. 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

    Time frame: 12 weeks

  13. 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

    Time frame: 24 weeks

07

Study locations

1 site
  • Kimyounggi Clinic
    Busan, South Korea
08

References and documents

Individual participant data

Plan to share: Undecided — Undecided at this point

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05889143
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Jun 5, 2023
Start date
May 24, 2023
Primary completion
Dec 31, 2024
Completion
Mar 1, 2026 (estimated)
Last update
Aug 24, 2025

Study contacts

JunYoung Park
study director · Daewoong Pharma

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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