Clinical trial NCT05889143: A Study to Evaluate the Efficacy and Safety of CREZET Tablet
Official title: A Prospective, Non-Intervention, Multi-Center Observational Study to Evaluate the Efficacy and Safety of CREZET Tablet in Patients With Dyslipidemia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dyslipidemias
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-06-05
Enrollment: 15000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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)

Eligibility criteria: 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:

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.

Primary outcomes:
measure: The Rate of change in LDL-C
timeFrame: 24 weeks
Secondary outcomes:
measure: The Rate of change in LDL-C
timeFrame: 12 weeks
measure: The change in HbA1c
timeFrame: 12 weeks
measure: The change in HbA1c
timeFrame: 24 weeks
measure: The change in FPG
timeFrame: 12 weeks
measure: The change in FPG
timeFrame: 24 weeks
measure: The chanage in lipid variable
timeFrame: 12 weeks
measure: The chanage in lipid variable
timeFrame: 24 weeks
measure: The change in AST
timeFrame: 12 weeks
measure: The change in AST
timeFrame: 24 weeks
measure: The change in ALT
timeFrame: 12 weeks
measure: The change in ALT
timeFrame: 24 weeks
measure: Percentage of subjects who reached LDL-C target
timeFrame: 12 weeks
measure: Percentage of subjects who reached LDL-C target
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Kimyounggi Clinic
Study officials:
affiliation: Daewoong Pharma
name: JunYoung Park
role: STUDY_DIRECTOR
References: