Bempedoic acid: new evidence and recommendations on use.
Kristina Paponja, Ivan Pećin, Željko Reiner...
https://pubmed.ncbi.nlm.nih.gov/38085172Actively Recruiting
Age: 18Years +
FEMALE
ID05103254
Bempedoic Acid Pregnancy Surveillance Program to Assess Risks of Pregnancy and Infant Outcomes in Women Exposed to Bempedoic Acid or Bempedoic Acid/Ezetimibe Combination
Led by Esperion Therapeutics, Inc. · Updated on 2024-05-17
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to observe females who have been exposed to bempedoic acid or the combination of bempedoic acid and ezetimibe during pregnancy. The study collects information on pregnancy outcomes and monitors infants through their first year of life to better understand potential risks associated with these drugs during pregnancy. Participants include pregnant females who have taken at least one dose of bempedoic acid or the fixed combination drug product at any point from the first day of their last menstrual period to the end of pregnancy. This is an observational study without assigned treatments, focusing on monitoring outcomes rather than administering specific interventions. Throughout the study, researchers will gather data on major and minor congenital malformations, pregnancy outcomes such as spontaneous abortion, stillbirth, elective termination, preterm birth, and infant growth and development during the first year. The study involves long-term follow-up of both mothers and infants to assess safety signals and gather detailed outcome data.
CONDITIONS
Brief Title
Bempedoic Acid Pregnancy Surveillance Program
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Exposure to at least one dose of bempedoic acid or bempedoic acid/ezetimibe fixed combination drug product at any time during pregnancy, from the first day of last menstrual period to pregnancy outcome
You will not qualify if you...
- No exclusion criteria listed in the provided information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to confirm exposure and consent
Surveillance
Duration - From conception to birth
Participants who were exposed to bempedoic acid or bempedoic acid/ezetimibe during pregnancy are observed throughout pregnancy to assess pregnancy outcomes.
Periodic assessments during pregnancy
Long-term Monitoring
Duration - Up to 12 months after birth
Infants born to participants are monitored for up to 12 months to assess health and developmental outcomes.
Multiple follow-up visits during the first year of life
Trial Site Locations
Total: 1 location
1
Evidera, PPD business unit
Morrisville, North Carolina, United States, 27560
Actively Recruiting
Loading map...
Research Team
E
Esperion Therapuetics
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here