CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 137 enrolled
Drug / intervention
Atozet 10/40 mg or 10/80 mg +1 moredrug
Likely dose
Atozet 10/40 mg or 10/80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05761444
NCT05761444Phase 4Completed
CompareCT.gov

A Phase 4, Multicenter, Randomized, Open-label, Active-controlled Study to Evaluate the Effectiveness and Safety of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients

Organon and Co·interventional·Posted Mar 9, 2023·Updated Sep 9, 2025

In Brief

A Phase 4 clinical trial evaluating Atozet 10/40 mg or 10/80 mg and Lipitor 40 mg or 80 mg for Atherosclerotic Cardiovascular Disease. Completed, enrolled 137 participants across 7 sites.

Detailed Summary

This study aims to confirm the effectiveness of ezetimibe add-on therapy on LDL-C levels compared to atorvastatin monotherapy, especially in very high-risk patients. We intend to lay the foundation for a standard treatment for these patients through ezetimibe add on lipid-lowering therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtherosclerotic Cardiovascular Disease
CountriesSouth Korea
CollaboratorsIQVIA Pty Ltd

Timeline

Phase 4CompletedFinished
202420252026
First PostedMar 9, 2023
Enrollment StartJul 26, 2023
Primary CompletionSep 4, 2024
Study CompletionOct 15, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.3 years ago

Interventions

Atozet 10/40 mg or 10/80 mgdrug

Atozet 10/40 mg or 10/80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily

Lipitor 40 mg or 80 mgdrug

Lipitor 40 mg or 80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily