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
Public ClinicalTrials.gov record NCT03415178. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03415178
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 69 participants
Conditions and interventions
Conditions
Interventions
- Alirocumab SAR236553 Drug
- Current auto-injector device (AI) Device
- New auto-injector device (SYDNEY) Device
- Atorvastatin Drug
- Rosuvastatin Drug
Drug · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 28, 2018
- Primary completion
- Aug 8, 2018
- Completion
- Aug 8, 2018
- Last update posted
- Sep 8, 2019
2018
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400024 | Los Angeles | California | 90057 | — |
| Investigational Site Number 8400007 | Jacksonville | Florida | 32216 | — |
| Investigational Site Number 8400017 | Jacksonville | Florida | 32223 | — |
| Investigational Site Number 8400013 | Ponte Vedra | Florida | 32081 | — |
| Investigational Site Number 8400014 | Wellington | Florida | 33449 | — |
| Investigational Site Number 8400001 | West Des Moines | Iowa | 50266 | — |
| Investigational Site Number 8400019 | Topeka | Kansas | 66606 | — |
| Investigational Site Number 8400006 | Cincinnati | Ohio | 45201 | — |
| Investigational Site Number 8400010 | Cincinnati | Ohio | 45219 | — |
| Investigational Site Number 8400022 | Summerville | South Carolina | 29485 | — |
| Investigational Site Number 8400026 | Amarillo | Texas | 79106 | — |
| Investigational Site Number 8400005 | Richmond | Virginia | 23227 | — |
| Investigational Site Number 8400027 | Manitowoc | Wisconsin | 54220 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03415178, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 8, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03415178 live on ClinicalTrials.gov.