Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-03-01 @ 5:00 PM
Study NCT ID:
NCT01764633
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2013-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOURIER
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: