Ignite Creation Date:
2024-05-06 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03415178
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2018-01-04
Brief Title:
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
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Efficacypharmacodynamics
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
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
Efficacypharmacodynamics
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1186-3466 | OTHER | UTN | None |