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COMPLETED Phase 3

Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension

NCT02867813 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 5,035 participants
Start Date 2016-09-02
Est. Completion 2022-03-21
Phase Phase 3

Sponsor

Amgen

266 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02867813

The ClinicalTrials.gov registry entry for NCT02867813 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,035 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02867813 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Colorado, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02867813?

The interventions under investigation include: Evolocumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02867813?

This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial