Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

• Status: Completed
• Trial end date: 2018-08-09

Summary

Primary Objective:

To collect real-use (usability) data assessing the robustness and user interaction of the new alirocumab auto-injector device (which is referred to as SYDNEY), in unsupervised settings.

Secondary Objective:

Device-related:

• To collect real-use (usability) data assessing the robustness and user interaction of SYDNEY and the current alirocumab auto-injector device (which is referred to as AI) in supervised settings.

Pharmacokinetics:

• To compare alirocumab pharmacokinetics (PK) administered using SYDNEY and AI.

• To evaluate alirocumab PK administered using SYDNEY.

Anti-drug antibodies:

• To evaluate the development of anti-drug (alirocumab) antibodies (ADA).

Efficacy/pharmacodynamics:

• To compare the percent and absolute change in low-density lipoprotein cholesterol (LDL-C) using SYDNEY and AI.

• To evaluate the percent and absolute change in LDL-C using SYDNEY.

Safety:

• To evaluate the safety and tolerability of alirocumab using both SYDNEY and AI.

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Atorvastatin; Rosuvastatin Calcium