NCT05103254

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Esperion Therapeutics, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

Bempedoic acid pregnancy surveillance program

Detailed 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.

Conditions

• Pregnancy
• Hyperlipidemias

Interventions

Type	Name	Description
DRUG	Bempedoic Acid	Bempedoic Acid 180 MG
DRUG	Bempedoic Acid / Ezetimibe	Bempedoic Acid 180 MG / Ezetimibe 10 MG

Timeline

• Start date: 2021-09-01
• Primary completion: 2032-05-01
• Completion: 2032-05-01
• First posted: 2021-11-02
• Last updated: 2024-05-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study