NCT05129241

Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector

Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector (MARS-NIS)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 163 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary objectives: * To assess the effectiveness of the PRALUENT® 2 ml SYDNEY auto-injector as measured by the lipid-lowering effect of alirocumab after approx. 12 weeks treatment * To assess the treatment satisfaction, as well as patient adherence and persistence after approximately 12 weeks of treatment with the PRALUENT® 2 ml SYDNEY auto-injector Secondary objective: Safety and tolerability

Detailed description

Study duration per participant is approximately 12 weeks

Conditions

• Primary Hypercholesterolaemia and Mixed Dyslipidaemia
• Atherosclerotic Cardiovascular Disease

Timeline

• Start date: 2021-11-18
• Primary completion: 2023-02-16
• Completion: 2023-02-16
• First posted: 2021-11-22
• Last updated: 2025-03-24

Locations

1 site across 1 country: Germany