Study detail
Recruiting
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
Esperion Therapeutics, Inc.
Summary
Bempedoic acid pregnancy surveillance program
Description
A surveillance study of females exposed to bempedoic acid or bempedoic acid/ezetimibe fixed combination drug product (FCDP) during pregnancy. Observational outcome data will be collected on pregnant females through pregnancy and infants through the first year of life.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Not specified
Detailed criteria
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:
Interventions
- DrugBempedoic Acid
Bempedoic Acid 180 MG
- DrugBempedoic Acid / Ezetimibe
Bempedoic Acid 180 MG / Ezetimibe 10 MG
Location
- Evidera, PPD business unitMorrisville, North Carolina