NCT05889143

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

May 25, 2023

Last Update Submit

August 22, 2025

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

  • The Rate of change in LDL-C

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

    24 weeks

Secondary Outcomes (13)

  • The Rate of change in LDL-C

    12 weeks

  • The change in HbA1c

    12 weeks

  • The change in HbA1c

    24 weeks

  • The change in FPG

    12 weeks

  • The change in FPG

    24 weeks

  • +8 more secondary outcomes

Study Arms (1)

Mucotra® SR Tab

Drug: Ezetimibe/Rosuvastatin

Interventions

Ezetimibe/RosuvastatinDRUG

Patient treated with Crezet Tablet

Also known as: Crezet Tablet
Mucotra® SR Tab

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kimyounggi Clinic

Busan, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

EzetimibeRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Study Officials

  • JunYoung Park

    Daewoong Pharma

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 5, 2023

Study Start

May 24, 2023

Primary Completion

December 31, 2024

Study Completion

March 1, 2026

Last Updated

August 24, 2025

Record last verified: 2025-08

Locations

KR(1)