NCT03415178

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hypercholesterolaemia

Interventions

Type	Name	Description
DRUG	Alirocumab SAR236553	Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
DEVICE	Current auto-injector device (AI)	Pharmaceutical form: Route of administration: Subcutaneous self-administration of alirocumab
DEVICE	New auto-injector device (SYDNEY)	Pharmaceutical form: Route of administration: Subcutaneous self-administration of alirocumab
DRUG	Atorvastatin	Pharmaceutical form:tablet Route of administration: oral
DRUG	Rosuvastatin	Pharmaceutical form:tablet Route of administration: oral

Timeline

• Start date: 2018-03-29
• Primary completion: 2018-08-09
• Completion: 2018-08-09
• First posted: 2018-01-30
• Last updated: 2019-09-09
• Results posted: 2019-09-09

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study