Trial Assessing Efficacy, Safety and Tolerability of PCSK9 Inhibition in Paediatric Subjects With Genetic LDL Disorders



Status:Recruiting
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:10 - 17
Updated:4/6/2019
Start Date:February 15, 2016
End Date:February 18, 2020
Contact:Amgen Call Center
Email:medinfo@amgen.com
Phone:866-572-6436

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Double-blind, Randomized, Multicenter, Placebo-Controlled Study to Characterize the Efficacy, Safety, and Tolerability of 24 Weeks of Evolocumab for LDL-C Reduction in Pediatric Subjects 10 to 17 Years of Age With HeFH

A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged
10-17 years diagnosed with heterozygous familial hypercholesterolemia.

A study to evaluate the effect of 24 weeks of subcutaneous (SC) evolocumab compared with
placebo,when added to standard of care, on percent change from baseline in low‑density
lipoprotein cholesterol (LDL-C) in pediatric subjects 10 to 17 years of age with HeFH

Inclusion Criteria:

- Male or female ≥ 10 to ≤ 17 years of age (before 18th birthday)

- Diagnosis of heterozygous familial hypercholesterolemia

- On an approved statin with stable optimized dose for ≥ 4 weeks

- Other lipid-lowering therapy stable for ≥ 4 weeks (fibrates must be stable for ≥ 6
weeks)

- Fasting LDL-C ≥ 130 mg/dL (3.4 mmol/L)

- Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:

- Type 1 diabetes, or type 2 diabetes that is or poorly controlled

- Uncontrolled hyperthyroidism or hypothyroidism

- Cholesterylester transfer protein (CETP) inhibitor in the last 12 months, or
mipomersen or lomitapide in the last 5 months

- Previously received evolocumab or any other investigational therapy to inhibit PCSK9.

- Lipid apheresis within the last 12 weeks prior to screening.

- Homozygous Familial Hypercholesterolemia
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