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NCT02624869 · ClinicalTrials.gov registry record · Phase 3
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 163
- Enrollment target
NCT02624869: Completed Phase 3 study, sponsored by Amgen.
NCT02624869 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 163 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02624869, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 163 participants
- Enrollment target
Study Summary
The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.
Primary Outcome
An adverse event is defined as any untoward medical occurrence in a clinical trial participant, not necessarily having a causal relationship with study treatment. A serious AE is as an AE that met at least 1 of the following criteria: * fatal; * life threatening; * required in-patient hospitalization or prolongation of existing hospitalization; * resulted in persistent or significant disability/incapacity; * congenital anomaly/birth defect; * other medically important serious event. AEs were
Interventions
- BIOLOGICAL Evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2016-09-10 |
| Est. Completion | 2021-06-01 |
| Phase | Phase 3 |
What the finished NCT02624869 record still lists
NCT02624869 is an interventional study that assigns participants to a tested intervention. The registered 163 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 (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Evolocumab is the first listed.
NCT02624869 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02624869 about?
NCT02624869 is a clinical study titled "Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)". The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.
What is the current status of trial NCT02624869?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 163 participants. The study started on 2016-09-10. Estimated completion is 2021-06-01.
What interventions are being tested in trial NCT02624869?
The interventions under investigation include: Evolocumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02624869?
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 NCT02624869's enrollment target sits among peer trials
163 1471st of 2000 higher than 527 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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