Hypercholesterolaemia Clinical Trial
Official title:
A Multicenter, Randomized, Open-label, Parallel-group Usability Study of the Commercial 1 mL Alirocumab Auto-injector Device (AI) and the New 2 mL Auto-injector Device (SYDNEY) in High or Very High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
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.
Total study duration per participant was expected to be up to 18 weeks, with up to 2 weeks of screening period and 16 weeks of study treatment period. ;
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