Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mucotra® SR Tab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe/Rosuvastatin | Drug | Patient treated with Crezet Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of change in LDL-C | The Rate of change in LDL-C at 24 weeks from baseline | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of change in LDL-C | The Rate of change in LDL-C at 12 weeks from baseline | 12 weeks |
| The change in HbA1c | The change in HbA1c at 12 weeks from baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| JunYoung Park | Daewoong Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kimyounggi Clinic | Busan | South Korea |
Undecided at this point
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 weeks |
| The change in HbA1c | The change in HbA1c at 24 weeks from baseline | 24 weeks |
| The change in FPG | The change in FPG at 12 weeks from baseline | 12 weeks |
| The change in FPG | The change in FPG at 24 weeks from baseline | 24 weeks |
| The chanage in lipid variable | The chanage in lipid variable at 12 weeks from baseline | 12 weeks |
| The chanage in lipid variable | The chanage in lipid variable at 24 weeks from baseline | 24 weeks |
| The change in AST | The change in AST at 12 weeks from baseline | 12 weeks |
| The change in AST | The change in AST at 24 weeks from baseline | 24 weeks |
| The change in ALT | The change in ALT at 12 weeks from baseline | 12 weeks |
| The change in ALT | The change in ALT at 24 weeks from baseline | 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 | 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 | 24 weeks |
| D013449 |
| Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |