CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 69 enrolled
Drug / intervention
Alirocumab SAR236553 +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03415178
NCT03415178Phase 3Completed
CompareCT.gov

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

Sanofi·interventional·Posted Jan 30, 2018·Updated Sep 9, 2019

In Brief

A Phase 3 clinical trial evaluating Alirocumab SAR236553, Current auto-injector device (AI), and 3 other interventions for Hypercholesterolaemia. Completed, enrolled 69 participants across 13 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolaemia
CountriesUnited States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJan 30, 2018
Enrollment StartMar 29, 2018
Primary CompletionAug 9, 2018
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 8.4 years ago

Interventions

Alirocumab SAR236553drug

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Current auto-injector device (AI)device

Pharmaceutical form: Route of administration: Subcutaneous self-administration of alirocumab

New auto-injector device (SYDNEY)device

Pharmaceutical form: Route of administration: Subcutaneous self-administration of alirocumab

Atorvastatindrug

Pharmaceutical form:tablet Route of administration: oral

Rosuvastatindrug

Pharmaceutical form:tablet Route of administration: oral