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Bempedoic Acid + Ezetimibe in Breast Milk of Healthy Lactating Women

Phase 4

Recruiting

Research Sponsored by Esperion Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 6

Awards & highlights

Study Summary

This trial will measure how much of a drug passes into breast milk and its effects on a baby's dose.

Who is the study for?

This trial is for healthy lactating women who have been breastfeeding for at least 4 weeks and are not pregnant. Participants must be willing to pump milk regularly, avoid breastfeeding during the study, use birth control if not surgically sterile, and cannot be current smokers or have significant health issues that could affect safety or results.Check my eligibility

What is being tested?

The study tests how much of the drugs bempedoic acid and a combination of bempedoic acid/ezetimibe end up in breast milk after taking them daily for six days. It aims to understand what dose an infant might receive through breast milk and assess any potential risks.See study design

What are the potential side effects?

While specific side effects in lactating women aren't detailed here, common side effects of these medications can include muscle pain, increased uric acid levels leading to gout, allergic reactions, cold-like symptoms, elevated liver enzymes which may indicate liver injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Daily infant dose (mg/d)

Relative infant dose (%)

Secondary outcome measures

Amount excreted in each breast milk collection, calculated as the product of concentration and milk volume collected

Area under the milk concentration-time curve (AUC) over a 24-hour collection interval

Average milk concentration based on milk AUC

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Bempedoic acid/ezetimibe fixed combination drug productExperimental Treatment1 Intervention

Group II: Bempedoic acidExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Esperion Therapeutics, Inc.Lead Sponsor

25 Previous Clinical Trials

21,902 Total Patients Enrolled

Christine Broestl, MSStudy DirectorEsperion Therapeutics, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could individuals beneath the age of fifty participate in this research?

"As per the trial's entry criteria, individuals between 18 and 45 are qualified to enroll. For those under 18 or over 65 years old, there is a separate study available for their age group."

Answered by AI

Is there a current recruitment process for this research project?

"According to the available data on clinicaltrials.gov, recruitment is still open for this trial which first went public on August 4th 2023 and was recently updated in late August of the same year."

Answered by AI

What are the eligibility criteria for participation in this clinical experiment?

"Eligibility requirements for this medical trial state that lactating women aged between 18 and 45 should apply. A total of 16 patients will be admitted to the study."

Answered by AI

What is the total number of volunteers enrolled in this research endeavor?

"Yes, the evidence on clinicaltrials.gov attests to this medical study being actively recruiting patients. Initially posted on August 4th 2023 and last edited 27 days later, 16 participants will be accepted from one site."

Answered by AI

What risks do individuals face when taking Bempedoic acid?

"Our analysts at Power gave bempedoic acid a rating of 3 out of 3 due to it having completed Phase 4 clinical trials, signifying that the treatment is officially approved."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women

2023. "Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06021951.

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