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NCT01764633 · ClinicalTrials.gov registry record · Phase 3
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 27,564
- Enrollment target
NCT01764633: Completed Phase 3 study, sponsored by Amgen.
NCT01764633 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 27,564 participants, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (3480% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01764633, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 27,564 participants
- Enrollment target
Study Summary
The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.
Primary Outcome
All deaths and potential endpoint events were adjudicated by an independent external Clinical Events Committee (CEC) led by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revas
Interventions
- DRUG Placebo
- BIOLOGICAL Evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27,564 participants |
| Start Date | 2013-02-08 |
| Est. Completion | 2016-11-11 |
| Phase | Phase 3 |
What the finished NCT01764633 record still lists
NCT01764633 is an interventional study that assigns participants to a tested intervention. Its 27,564 participants enrollment target places it among the larger protocols in the corpus, above the 770-participant average among 15,282 other Phase 3 trials with a reported enrollment target (3480% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01764633 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01764633 about?
NCT01764633 is a clinical study titled "Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk". The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident c...
What is the current status of trial NCT01764633?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 27,564 participants. The study started on 2013-02-08. Estimated completion is 2016-11-11.
What interventions are being tested in trial NCT01764633?
The interventions under investigation include: Placebo (DRUG), Evolocumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01764633?
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 NCT01764633's enrollment target sits among peer trials
27,564 6th of 2000 higher than 1,995 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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