Phase 3 Heart Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Children aged 6 years old up to (but not including) 12 years old at the time of screening, of any sex
- Children who have been diagnosed with a condition called heterozygous familial hypercholesterolemia (HeFH) — an inherited condition that causes high cholesterol — either through a genetic test or based on physical and clinical signs
- Children whose fasting LDL ("bad") cholesterol level is above 130 mg/dL (or 3.4 mmol/L) at screening
- Children aged 8 to under 12 must be taking the highest appropriate dose of a cholesterol-lowering medicine called a statin (unless they cannot tolerate statins), and may also be taking other cholesterol-lowering medicines such as ezetimibe
- For children under 8, the decision about whether to use cholesterol-lowering medicines is left to the treating doctor's judgement
- Children already taking cholesterol-lowering medicines must have been on a stable, unchanged dose for at least 30 days before screening, with no planned changes to those medicines during the study
Who may not be able to join:
- Children who have received a specific type of medicine called a PCSK9 inhibitor (a monoclonal antibody targeting PCSK9) within the 90 days before screening
- Children whose high cholesterol is caused by another medical condition, such as an underactive thyroid or a kidney condition called nephrotic syndrome
- Children diagnosed with homozygous familial hypercholesterolemia (HoFH), which is a more severe inherited form of high cholesterol (different from HeFH)
- Children who weigh less than 16 kg at the time of screening or at the start of the study
- Children with active liver disease, or certain abnormal liver blood test results above specified levels (confirm with trial site), except in cases of a specific harmless condition called Gilbert's syndrome
- Females who are pregnant or breastfeeding
- Children who have recently used or are planning to use another experimental medicine or medical device during the study
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Phone: 1-888-669-6682
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Percentage change in LDL-C from baseline to Day 330 (Year 1)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.