Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06021951 · ClinicalTrials.gov registry record · Phase 4
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
A Phase 4 study, sponsored by Esperion Therapeutics.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT06021951 is a Phase 4 study that has completed, run by Esperion Therapeutics. The registered enrollment target is 16 participants.
The verdict
NCT06021951, a Phase 4 study, has completed, sponsored by Esperion Therapeutics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study is designed to characterize the excretion of bempedoic acid or bempedoic acid and ezetimibe into mature breast milk of healthy lactating women and assess the exposure to the breast fed infant by estimating the daily infant dosage and the relative infant dose (RID) of bempedoic acid or bempedoic acid and ezetimibe in breast milk after 6 consecutive daily doses of bempedoic acid or bempedoic acid/ezetimibe FCDP.
Interventions
- DRUG Bempedoic Acid 180 MG Oral Tablet
- DRUG Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-08-04 |
| Est. Completion | 2024-03-22 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06021951
The ClinicalTrials.gov registry entry for NCT06021951 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Esperion Therapeutics, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bempedoic Acid 180 MG Oral Tablet is the first listed.
NCT06021951 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06021951 about?
NCT06021951 is a clinical study titled "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". This study is designed to characterize the excretion of bempedoic acid or bempedoic acid and ezetimibe into mature breast milk of healthy lactating women and assess the exposure to the breast fed infant by estimating the daily infant dosage and the relative infant dose (RID) of bempedoic acid or bem...
What is the current status of trial NCT06021951?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2023-08-04. Estimated completion is 2024-03-22.
What interventions are being tested in trial NCT06021951?
The interventions under investigation include: Bempedoic Acid 180 MG Oral Tablet (DRUG), Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT06021951?
This trial is sponsored by Esperion Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.