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A Phase 2 Clinical Study in Children With HeFH Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing - Trial NCT05694260

Access comprehensive clinical trial information for NCT05694260 through Pure Global AI's free database. This Phase 2 trial is sponsored by Esperion Therapeutics, Inc. and is currently Recruiting. The study focuses on Hypercholesterolemia. Target enrollment is 54 participants.

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NCT05694260
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05694260
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A Phase 2 Clinical Study in Children With HeFH Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing
An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Bempedoic Acid in Pediatric Patients (6 to 17 Years of Age) With Heterozygous Familial Hypercholesterolemia

Study Focus

Hypercholesterolemia

Bempedoic acid

Interventional

drug

Sponsor & Location

Esperion Therapeutics, Inc.

Saint Louis,Salt Lake City,Chicoutimi,Hannover, Canada,Germany,United States of America

Timeline & Enrollment

Phase 2

Jan 12, 2023

May 24, 2024

54 participants

Primary Outcome

Observed pharmacokinetics - trough plasma concentration of ETC-1002,Model-based pharmacokinetics - AUC, ss,Model-based pharmacokinetics - Cavg, ss,Model-based pharmacokinetics - Cmax, ss

Summary

Multiple-dose study to measure PK, PD and safety of bempedoic acid in pediatric patients 6 to
 17 years of age with HeFH.

ICD-10 Classifications

Pure hypercholesterolaemia
Lipoprotein deficiency
Hyperglycaemia, unspecified
Disorders of lipoprotein metabolism and other lipidaemias
Other disorders of lipoprotein metabolism

Data Source

ClinicalTrials.gov

NCT05694260

Non-Device Trial