RecruitingNCT05103254

Bempedoic Acid Pregnancy Surveillance Program

A Post-marketing, Long-term, Observational, Descriptive Study to Assess the Risk of Pregnancy and Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Women Exposed to Bempedoic Acid or Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) During Pregnancy


Sponsor

Esperion Therapeutics, Inc.

Enrollment

20 participants

Start Date

Sep 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Bempedoic acid pregnancy surveillance program


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria1

  • 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

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Interventions

DRUGBempedoic Acid

Bempedoic Acid 180 MG

DRUGBempedoic Acid / Ezetimibe

Bempedoic Acid 180 MG / Ezetimibe 10 MG


Locations(1)

Evidera, PPD business unit

Morrisville, North Carolina, United States

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NCT05103254


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