NCT05761444

Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherosclerotic Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Atozet 10/40 mg or 10/80 mg	Atozet 10/40 mg or 10/80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily
DRUG	Lipitor 40 mg or 80 mg	Lipitor 40 mg or 80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily

Timeline

• Start date: 2023-07-26
• Primary completion: 2024-09-04
• Completion: 2024-10-15
• First posted: 2023-03-09
• Last updated: 2025-09-09
• Results posted: 2025-09-09

Locations

7 sites across 1 country: South Korea