Clinical trial
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
Name
1002-074
Description
Bempedoic acid pregnancy surveillance program
Trial arms
Trial start
2021-09-01
Estimated PCD
2032-05-01
Trial end
2032-05-01
Status
Recruiting
Treatment
Bempedoic Acid
Bempedoic Acid 180 MG
Other names:
Nexletol
Bempedoic Acid / Ezetimibe
Bempedoic Acid 180 MG / Ezetimibe 10 MG
Other names:
Nexlizet
Size
20
Primary endpoint
Major congenital malformations (MCM)
Birth up to 12 months
Eligibility 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:
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2023-02-21
1 organization
2 products
2 indications
Organization
Esperion TherapeuticsProduct
Bempedoic AcidIndication
PregnancyIndication
HyperlipidemiaProduct
Bempedoic Acid + Ezetimibe