Phase 4
N=137
Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients
Atherosclerotic Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT05761444 ↗Enrolled (actual)
137
Serious AEs
5.1%
Results posted
Sep 2025
Primary outcome: Primary: Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 6 — -48.97; -27.75 percentage change — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atozet 10/40 mg or 10/80 mg (Drug); Lipitor 40 mg or 80 mg (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 6 |
-48.97; -27.75 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <55 mg/dL at Weeks 6 and 12 |
46.2; 9.0; 55.0; 15.4 | — |
| SECONDARY Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <70 mg/dL at Weeks 6 and 12 |
78.5; 38.8; 85.0; 58.5 | — |
| SECONDARY Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 12 |
-50.37; -34.41 | <0.0001 sig |
| SECONDARY Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Triglycerides, and Total Cholesterol at Weeks 6 and 12 |
-2.44; -0.18; -2.15; -1.47; -35.36; -24.36 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) at Weeks 6 and 12 |
9; 8; 3; 2; 15; 13 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Event Leading to the Premature Discontinuation of the Study |
2; 2; 3; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients who are ≥ 30 years old.
- Patients with very high-risk*: clinical or unequivocal on imaging ASCVD. ASCVD includes previous ACS (MI or UA), stable angina, coronary revascularization (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), and other arterial revascularization procedures), stroke and transient ischaemic attack (TIA), and peripheral arterial disease (Mach F 2020).
- Patients (a) who failed to achieve their target LDL-C goals with low and/or moderate intensity statin mono therapy for ≥ 4 weeks or (b) who are statin-naïve or have not been on a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment
- rosuvastatin 3 x upper limit of normal (ULN)).
- Patients who have predisposing conditions with muscle disease (i.e., rhabdomyolysis or myopathy) or neuromuscular disease.
- Patients with myasthenia gravis.
- Female patients who are pregnant or have a potential to be pregnant and nursing.
- Patients who are taking glecaprevir and pibrentasvir.
- Patients with hereditary problems of galactose intolerance, lapp lactase deficiency, or of glucose-galactose malabsorption.
- Patients with disease known to influence serum lipids or lipoproteins excluding dyslipidemia.
- Patients with a history of cancer within 5 years.
- Patients whose life expectancy is less than 6 months due to their medical conditions.
- Patients with any condition or situation that might pose a risk to the participant or interfere with participation in the study.
- Patients who have received any investigational medicine within 12 weeks of written informed consent or are going to receive during the clinical trial period.
- Patients who are judged to be difficult to conduct clinical trials according to the judgment of the investigator.
Data sourced from ClinicalTrials.gov (NCT05761444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.