# Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study

> **NCT03379558** · — · TERMINATED · sponsor: **Regeneron Pharmaceuticals** · enrollment: 37 (actual)

## Conditions studied

- Hypercholesterolemia

## Interventions

- **DRUG:** ALIROCUMAB SAR236553 (REGN727)

## Key facts

- **NCT ID:** NCT03379558
- **Lead sponsor:** Regeneron Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** TERMINATED
- **Start date:** 2017-12-19
- **Primary completion:** 2020-09-04
- **Final completion:** 2020-09-04
- **Target enrollment:** 37 (ACTUAL)
- **Why stopped:** (due to change in the post-marketing requirement to assess alirocumab during pregnancy)
- **Last updated:** 2020-11-23

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03379558

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03379558, "Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study". Retrieved via AI Analytics 2026-05-31 from https://api.ai-analytics.org/clinical/NCT03379558. Licensed CC0.

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