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Clinical Trials in the USA / NCT05103254
Recruiting Observational

Bempedoic Acid Pregnancy Surveillance Program

NCT05103254 · tracked via the Priya Life Science USA tracker
Sponsor
Esperion Therapeutics, Inc
Phase
Observational
Started
2021-09-01
Last updated
2024-05-17

Condition(s) studied

PregnancyHyperlipidemias

Investigational drug(s) / intervention(s)

Bempedoic Acid →Bempedoic Acid / Ezetimibe

Bempedoic Acid: Bempedoic Acid 180 MG

Bempedoic Acid / Ezetimibe: Bempedoic Acid 180 MG / Ezetimibe 10 MG

Study summary

Bempedoic acid pregnancy surveillance program

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Exposure to at least 1 dose of bempedoic acid or bempedoic acid/ezetimibe FCDP at any time during pregnancy (from first day of last menstrual period \[LMP\] to pregnancy outcome Exclusion Criteria:

Primary outcome measure(s)

  • Major congenital malformations (MCM) — Birth up to 12 months
    An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention (CDC 2019a). MCMs will be defined and coded with criteria specified by US CDC Metropolitan Atlanta Congenital Defects Program (MACDP).

Trial sites (1)

FacilityCityRegionStatus
Evidera, PPD business unit Morrisville North Carolina Recruiting

Other trials for the same condition

External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy Recruiting
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy Recruiting
A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy Enrolling by invitation
Cocooned Moms Study Recruiting
A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05103254 on ClinicalTrials.gov ↗ ← All trials in the USA