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NCT01624142 · ClinicalTrials.gov registry record · Phase 2
Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
NCT01624142: Completed Phase 2 study, sponsored by Amgen.
NCT01624142 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 300 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01624142, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 300 participants
- Enrollment target
Study Summary
A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.
Primary Outcome
The severity of each adverse event (AE) was graded according to the National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) grading scale, where grade 1 = mild AE, grade 2 = moderate AE, grade 3 = severe AE, grade 4 = life-threatening AE and grade 5 = death due to AE.
Interventions
- BIOLOGICAL Evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2012-06-01 |
| Est. Completion | 2018-05-11 |
| Phase | Phase 2 |
What the finished NCT01624142 record still lists
NCT01624142 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher).
The record links to 0 conditions, and to 1 intervention - of which Evolocumab is the first listed.
NCT01624142 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01624142 about?
NCT01624142 is a clinical study titled "Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders". A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.
What is the current status of trial NCT01624142?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2012-06-01. Estimated completion is 2018-05-11.
What interventions are being tested in trial NCT01624142?
The interventions under investigation include: Evolocumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01624142?
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 NCT01624142's enrollment target sits among peer trials
300 167th of 2000 higher than 1,813 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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