Clinical Trial Details
| Trial ID: | L3084 |
| Source ID: | NCT06767774 |
| Associated Drug: | Combination Therapy |
| Title: | Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus |
| Acronym: | |
| Status: | NOT_YET_RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | ASCVD|Diabetes|Statin |
| Interventions: | DRUG: Combination therapy|DRUG: High intensity statin monotherapy |
| Outcome Measures: | Primary: new-onset diabetes mellitus meeting diagnostic criteria for conventional diabetes during the treatment period, 3 years | Secondary: 1. Composite of major clinical events of cardiovascular disease (death from cardiovascular disease, nonfatal myocardial infarction or nonfatal stroke), 3 years | Other: Reperfusion procedure for any type of artery, 3 years|3. Individual components of the composite of major clinical events of cardiovascular disease, 3 years|Death from any cause, 3 years|An element of the criteria met at diagnosis of diabetes mellitus, 3 years|HOMA-IR, 3 years|Incidence of statin side effect, 3 years|Drug Adherence, Proportion of patients achieving ≥80% adherence to prescribed medication from baseline to 3 years, 3 years|Change in LDL cholesterol during follow-up, 3 years|Change in HbA1c during follow-up, 3 years|Change in Fasting glucose during follow-up, 3 years|Change in Insulin during follow-up, 3 years |
| Sponsor/Collaborators: | Sponsor: Korea University Anam Hospital | Collaborators: Daewon Pharmaceutical Co., Ltd.|Samjin Pharmaceutical Co., Ltd. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 2000 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION |
| Start Date: | 2025-01-20 |
| Completion Date: | 2030-01-31 |
| Results First Posted: | |
| Last Update Posted: | 2025-01-16 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT06767774 |
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