Bempedoic Acid Pregnancy Surveillance Program

Purpose

Bempedoic acid pregnancy surveillance program

Conditions

  • Pregnancy
  • Hyperlipidemias

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Recruiting Locations

Evidera, PPD business unit
Morrisville, North Carolina 27560

More Details

Status
Recruiting
Sponsor
Esperion Therapeutics, Inc.

Study Contact

Esperion Therapuetics
1 833 377 7633 (Option 5)
Bempedoic.Acid.PSP@ppd.com

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.