Continental Clinical Solutions | Towson, MD
Status and phase
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About
Multiple-dose study to measure PK, PD and safety of bempedoic acid in pediatric patients 6 to 17 years of age with HeFH.
Full description
Dose-selection based on body weight will be determined for use in pediatric clinical development
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Written informed consent and assent (where applicable) Aged 6-17 years old Diagnosis of HeFH (heterozygous familial hypercholesterolemia) Treatment with approved stable lipid modifying therapies Fasting LDL-C greater than or equal to 130 mg/dL (3.4 mmol/L)
Exclusion criteria
Diagnosis of HoFH (homozygous familial hypercholesterolemia) or compound HeFH Fasting Triglyceride greater than or equal to 400 mg/dL (4.5 mmol/L) Type 1 or Type 2 diabetes or newly diagnosed impaired glucose tolerance Women/girls who are pregnant or breastfeeding
Primary purpose
Allocation
Interventional model
Masking
54 participants in 3 patient groups
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Central trial contact
Esperion Medical Information
Data sourced from clinicaltrials.gov
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