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NCT02867813 · ClinicalTrials.gov registry record · Phase 3
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
A Phase 3 study of Dyslipidemia, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 5,035
- Enrollment target
- 20
- Study locations
NCT02867813: Completed Phase 3 study of Dyslipidemia, sponsored by Amgen.
NCT02867813 is a Phase 3 study of Dyslipidemia that has completed, run by Amgen. The registered enrollment target is 5,035 participants, above the 237-participant average among 40 other Dyslipidemia trials with a reported enrollment target (2024% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02867813, a Phase 3 study of Dyslipidemia, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5,035 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).
Primary Outcome
All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.
Conditions Studied
Interventions
- BIOLOGICAL Evolocumab
Study Locations (20)
California
- Research Site - Banning
- Research Site - Long Beach
- Research Site - Oceanside
- Research Site - Oxnard
- Research Site - Palm Springs
- Research Site - Roseville
- Research Site - San Diego
- Research Site - San Pedro
- Research Site - Tarzana
- Research Site - Torrance
- Research Site - Valley Village
Colorado
- Research Site - Aurora
- Research Site - Colorado Springs
- Research Site - Denver
- Research Site - Littleton
Alabama
- Research Site - Birmingham
- Research Site - Huntsville
Florida
- Research Site - Boynton Beach
- Research Site - Clearwater
Arizona
- Research Site - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,035 participants |
| Start Date | 2016-09-02 |
| Est. Completion | 2022-03-21 |
| Phase | Phase 3 |
What the finished NCT02867813 record still lists
NCT02867813 is an interventional study that assigns participants to a tested intervention. Its 5,035 participants enrollment target places it among the larger protocols in the corpus, above the 237-participant average among 40 other Dyslipidemia trials with a reported enrollment target (2024% higher).
The record links to 1 condition, with Dyslipidemia appearing as the primary indexed condition, and to 1 intervention - of which Evolocumab is the first listed.
NCT02867813 names 20 study sites across 5 states, led by California, Colorado, Alabama.
Frequently Asked Questions
What is clinical trial NCT02867813 about?
NCT02867813 is a clinical study titled "Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension". The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).
What is the current status of trial NCT02867813?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,035 participants. The study started on 2016-09-02. Estimated completion is 2022-03-21.
What conditions does trial NCT02867813 study?
This clinical trial studies the following conditions: Dyslipidemia.
What interventions are being tested in trial NCT02867813?
The interventions under investigation include: Evolocumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02867813?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02867813 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dyslipidemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02867813's enrollment target sits among peer trials
5,035 1st of 40 higher than 40 of 40 other Dyslipidemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dyslipidemia 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.
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