Trials / Completed
CompletedNCT02392559
Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 158 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 10 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
Detailed description
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 heterozygous familial hypercholesterolemia (HeFH).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Evolocumab | Dose of subcutaneous evolocumab every 4 weeks |
| DRUG | Placebo | Dose of subcutaneous placebo treatment every 4 weeks |
Timeline
- Start date
- 2016-03-24
- Primary completion
- 2019-11-25
- Completion
- 2019-11-25
- First posted
- 2015-03-19
- Last updated
- 2022-11-08
- Results posted
- 2020-07-15
Locations
66 sites across 26 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, Finland, Greece, Hungary, Italy, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT02392559. Inclusion in this directory is not an endorsement.