Bempedoic Acid Pregnancy Surveillance Program

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05103254
• Other study ID #: 1002-074
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: May 2032

Study information

• Verified date: May 2024
• Source: Esperion Therapeutics, Inc.
• Contact: Esperion Therapuetics
• Phone: 1 833 377 7633 (Option 5)
• Email: Bempedoic.Acid.PSP[@]ppd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2032
• Est. primary completion date: May 2032
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Hyperlipidemias
• Pregnancy

Intervention

Drug:
• Bempedoic Acid
Bempedoic Acid 180 MG
• Bempedoic Acid / Ezetimibe
Bempedoic Acid 180 MG / Ezetimibe 10 MG

Locations

Country	Name	City	State
United States	Evidera, PPD business unit	Morrisville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Esperion Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major congenital malformations (MCM)	An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention (CDC 2019a). MCMs will be defined and coded with criteria specified by US CDC Metropolitan Atlanta Congenital Defects Program (MACDP).	Birth up to 12 months
Secondary	Minor congenital malformation	An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e., birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual (CDC 2019a). The surveillance program defines and codes minor congenital malformations with criteria specified as defined by CDC (CDC 2017).	Birth up to 12 months
Secondary	Spontaneous abortion	An involuntary fetal loss or the expulsion of the products of conception occurring at < 20 gestational weeks.	Time of conception up to birth
Secondary	Stillbirth	As defined by the American College of Obstetricians and Gynecologists (ACOG), an involuntary fetal loss occurring at = 20 gestational weeks or, if gestational age is unknown, a fetus weighing = 350 g.	Time of conception up to birth
Secondary	Elective termination	A voluntary fetal loss or interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health or due to fetal abnormalities.	Time of conception up to birth
Secondary	Preterm birth	A live birth occurring at < 37 gestational weeks.	Time of conception up to birth
Secondary	Small for gestational age (SGA)	Weight at birth in < 10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants (Battaglia 1967). For the determination of SGA, the surveillance program will utilize the sex-specific international growth reference standards from the International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH-21st) for those born between 240/7 and 426/7 gestational weeks (Villar 2014; Villar 2016). The INTERGROWTH-21st standards are the latest available global reference standards, representing contemporary information from an international, multiethnic, diverse population, and have been specifically developed for modern research.	Birth up to 12 months
Secondary	Postnatal growth deficiency	Weight in < 10th percentile for sex and chronological age using standard growth charts. Postnatal growth deficiency will be evaluated at 4 and 12 months of infant age. For the determination of postnatal growth deficiency, the surveillance program will utilize the sex-specific international growth reference standards from the World Health Organization for children ages 0 to 24 months. The World Health Organization growth standards are recommended for use in the US for infants and children 0 to 2 years of age (CDC 2010).	Birth up to 12 months
Secondary	Infant development deficiency	Failure to achieve the developmental milestones for chronological age, as defined by the CDC (CDC 2019b). Infant developmental deficiency will be evaluated at 4 and 12 months of infant age for each CDC-defined category (social/emotional, language/communication, cognitive, and movement/physical development), separately.	Birth up to 12 months