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
1 other identifier
observational
20
1 country
1
Brief Summary
Bempedoic acid pregnancy surveillance program
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 21, 2021
CompletedFirst Posted
Study publicly available on registry
November 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2032
May 17, 2024
May 1, 2024
10.7 years
October 21, 2021
May 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Minor congenital malformation
Birth up to 12 months
Spontaneous abortion
Time of conception up to birth
Stillbirth
Time of conception up to birth
Elective termination
Time of conception up to birth
Preterm birth
Time of conception up to birth
- +3 more secondary outcomes
Interventions
Eligibility Criteria
Primary care
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Evidera, PPD business unit
Morrisville, North Carolina, 27560, United States
Related Publications (1)
Paponja K, Pecin I, Reiner Z, Banach M. Bempedoic acid: new evidence and recommendations on use. Curr Opin Lipidol. 2024 Feb 1;35(1):41-50. doi: 10.1097/MOL.0000000000000911. Epub 2023 Dec 8.
PMID: 38085172DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christine Broestl, MS
Esperion Therapuetics
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2021
First Posted
November 2, 2021
Study Start
September 1, 2021
Primary Completion (Estimated)
May 1, 2032
Study Completion (Estimated)
May 1, 2032
Last Updated
May 17, 2024
Record last verified: 2024-05