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COMPLETED 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

NCT03415178 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 69 participants
Start Date 2018-03-29
Est. Completion 2018-08-09
Phase Phase 3

Sponsor

Sanofi

275 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03415178 reports 13 study locations spanning 9 distinct geographic areas — top geographies include Florida, Ohio, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03415178?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial