Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03415178 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study of Hypercholesterolaemia, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 69
- Enrollment target
- 13
- Study locations
NCT03415178 is a Phase 3 study of Hypercholesterolaemia that has completed, run by Sanofi. The registered enrollment target is 69 participants, below the 5,033-participant average among 3 other Hypercholesterolaemia trials with a reported enrollment target (99% lower). The trial reports 13 study locations across 9 states.
The verdict
NCT03415178, a Phase 3 study of Hypercholesterolaemia, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 69 participants
- Enrollment target
- 13
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Rosuvastatin
- DRUG Atorvastatin
- DRUG Alirocumab SAR236553
- DEVICE Current auto-injector device (AI)
- DEVICE New auto-injector device (SYDNEY)
Study Locations (13)
Florida
- Investigational Site Number 8400007 - Jacksonville
- Investigational Site Number 8400017 - Jacksonville
- Investigational Site Number 8400013 - Ponte Vedra
- Investigational Site Number 8400014 - Wellington
Ohio
- Investigational Site Number 8400006 - Cincinnati
- Investigational Site Number 8400010 - Cincinnati
California
- Investigational Site Number 8400024 - Los Angeles
Iowa
- Investigational Site Number 8400001 - West Des Moines
Kansas
- Investigational Site Number 8400019 - Topeka
South Carolina
- Investigational Site Number 8400022 - Summerville
Texas
- Investigational Site Number 8400026 - Amarillo
Virginia
- Investigational Site Number 8400005 - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2018-03-29 |
| Est. Completion | 2018-08-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03415178
The ClinicalTrials.gov registry entry for NCT03415178 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,033-participant average among 3 other Hypercholesterolaemia trials with a reported enrollment target (99% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypercholesterolaemia appearing as the primary indexed condition, and to 5 interventions - of which Rosuvastatin is the first listed.
NCT03415178 reports 13 study locations spanning 9 distinct geographic areas - top geographies include Florida, Ohio, California.
Frequently Asked Questions
What is clinical trial NCT03415178 about?
NCT03415178 is a clinical study titled "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". 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 r...
What is the current status of trial NCT03415178?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 69 participants. The study started on 2018-03-29. Estimated completion is 2018-08-09.
What conditions does trial NCT03415178 study?
This clinical trial studies the following conditions: Hypercholesterolaemia.
What interventions are being tested in trial NCT03415178?
The interventions under investigation include: Rosuvastatin (DRUG), Atorvastatin (DRUG), Alirocumab SAR236553 (DRUG), Current auto-injector device (AI) (DEVICE), New auto-injector device (SYDNEY) (DEVICE).
Who is sponsoring clinical trial NCT03415178?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03415178 being conducted?
This trial has 13 study locations across California, Florida, Iowa, Kansas, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypercholesterolaemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes
ACTIVE NOT RECRUITING · Phase 3
-
Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)
COMPLETED · Phase 3
-
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
COMPLETED · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.