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NCT02392559 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 158
- Enrollment target
NCT02392559: Completed Phase 3 study, sponsored by Amgen.
NCT02392559 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 158 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02392559, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 158 participants
- Enrollment target
Study Summary
A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
Primary Outcome
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from interactive voice response system \[IVRS\]), scheduled visit and the interaction of treatment with scheduled visit as covariates. The model uses an unstructured covariance.
Interventions
- DRUG Placebo
- DRUG Evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2016-03-24 |
| Est. Completion | 2019-11-25 |
| Phase | Phase 3 |
What the finished NCT02392559 record still lists
NCT02392559 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02392559 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02392559 about?
NCT02392559 is a clinical study titled "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". A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
What is the current status of trial NCT02392559?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 158 participants. The study started on 2016-03-24. Estimated completion is 2019-11-25.
What interventions are being tested in trial NCT02392559?
The interventions under investigation include: Placebo (DRUG), Evolocumab (DRUG).
Who is sponsoring clinical trial NCT02392559?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02392559's enrollment target sits among peer trials
158 1502nd of 2000 higher than 496 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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