| Trial ID: | L4248 |
| Source ID: | NCT06293417
|
| Associated Drug: |
Ezetimibe/Fenofibrate (Ezefeno) And Moderate-Intensity Statin
|
| Title: |
To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM
|
| Acronym: |
ENSEMBLE
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
T2DM (Type 2 Diabetes Mellitus)|Dyslipidemias
|
| Interventions: |
DRUG: Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin|DRUG: Dose escalation of moderate-intensity statin
|
| Outcome Measures: |
Primary: major adverse cardiovascular events and diabetic microvascular events for 48 months, major adverse cardiovascular events and diabetic microvascular events for 48 months, 48month from baseline | Secondary: proportion of patients achieving Non-HDL-C less than 100mg/dL, proportion of patients achieving Non-HDL-C less than 100mg/dL, 48month from baseline|proportion of patients achieving LDL less than 70mg/dL, proportion of patients achieving LDL less than 70mg/dL, 48month from baseline|change in Non-HDL-C at 48month from baseline, change in Non-HDL-C at 48month from baseline, 48month from baseline|change in LDL at 48month from baseline, change in LDL at 48month from baseline, 48month from baseline|change in HDL-C at 48month from baseline, change in HDL-C at 48month from baseline, 48month from baseline|change in TG at 48month from baseline, change in TG at 48month from baseline, 48month from baseline|change in LDL-C/HDL-C ratio at 48month from baseline, change in LDL-C/HDL-C ratio at 48month from baseline, 48month from baseline|change in TC/HDL-C ratio at 48month from baseline, change in TC/HDL-C ratio at 48month from baseline, 48month from baseline
|
| Sponsor/Collaborators: |
Sponsor: Korea University Anam Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
3958
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-03-01
|
| Completion Date: |
2027-02-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-08-27
|
| Locations: |
Korea University Anam Hospital, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT06293417
|
