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NCT03379558 · ClinicalTrials.gov registry record
Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
A clinical trial, sponsored by Regeneron Pharmaceuticals.
- Terminated
- Registry status
- 37
- Enrollment target
NCT03379558 is a clinical trial that was terminated before completion, run by Regeneron Pharmaceuticals. The registered enrollment target is 37 participants.
The verdict
NCT03379558 was terminated before completion, sponsored by Regeneron Pharmaceuticals.
- TERMINATED
- Registry status
- 37 participants
- Enrollment target
Study Summary
Primary Objective: To estimate the overall combined rate of major structural birth defects in infants of mothers with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent® (alirocumab) during pregnancy when used to treat hypercholesterolemia and to compare that rate to unexposed disease-matched and unexposed non-diseased comparison pregnancies. Secondary Objectives: * Secondary objectives are to estimate the rates of the outcomes in pregnancies/infants of mothers with atherosclerotic cardiovascular disease and/or familial hypercholesterolemia exposed to alirocumab during pregnancy when used to treat hypercholesterolemia and to compare that rate to unexposed disease-matched and non-diseased comparison pregnancies, and secondarily to compare the rates of these outcomes in the unexposed disease-matched pregnancies to the rates in the unexposed non-diseased comparison pregnancies. * Safety and tolerability of alirocumab.
Interventions
- DRUG ALIROCUMAB SAR236553 (REGN727)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2020-09-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03379558
The ClinicalTrials.gov registry entry for NCT03379558 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ALIROCUMAB SAR236553 (REGN727) is the first listed.
NCT03379558 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03379558 about?
NCT03379558 is a clinical study titled "Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study". Primary Objective: To estimate the overall combined rate of major structural birth defects in infants of mothers with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent® (alirocumab) during pregnancy when used to treat hypercholesterolemia a...
What is the current status of trial NCT03379558?
This trial is currently terminated. The enrollment target is 37 participants. The study started on 2017-12-19. Estimated completion is 2020-09-04.
What interventions are being tested in trial NCT03379558?
The interventions under investigation include: ALIROCUMAB SAR236553 (REGN727) (DRUG).
Who is sponsoring clinical trial NCT03379558?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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