Bempedoic Acid Pregnancy Surveillance Program

NCT ID: NCT05103254

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2032-05-31

Brief Summary

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Bempedoic acid pregnancy surveillance program

Detailed Description

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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.

Conditions

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Pregnancy Hyperlipidemias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Bempedoic Acid

Bempedoic Acid 180 MG

Intervention Type DRUG

Bempedoic Acid / Ezetimibe

Bempedoic Acid 180 MG / Ezetimibe 10 MG

Intervention Type DRUG

Other Intervention Names

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Nexletol Nexlizet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Esperion Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Broestl, MS

Role: STUDY_DIRECTOR

Esperion Therapuetics

Locations

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Evidera, PPD business unit

Morrisville, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Esperion Therapuetics

Role: CONTACT

1 833 377 7633 (Option 5)

References

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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.

Reference Type DERIVED
PMID: 38085172 (View on PubMed)

Other Identifiers

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1002-074

Identifier Type: -

Identifier Source: org_study_id

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