Clinical Trial Summary : 20110118
Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects With Elevated Risk  (FOURIER) FDA Regulated: Yes

This study has been completed.
Verified by Amgen, June 2017

Sponsored by: Amgen
Information provided by: Amgen

Delayed Results Posting
Delay Type: Certify New Use
Intervention Name: Evolocumab
FDA Application Numbers:
Requested Submission Date:  
Explanation:

Purpose

The primary hypothesis is that additional LDL-C lowering with Evolocumab (AMG 145) when used in addition to other treatment for dyslipidemia is well tolerated and decreases the risk of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization in subjects with clinically evident cardiovascular disease.


Condition Intervention Phase
Dyslipidemia
Biological/Vaccine: Evolocumab (AMG 145)
Other: Placebo
Drug: Effective statin therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind   (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Further study details as provided by Amgen

Primary Outcome Measures:
  • The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization whichever occurs first. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The primary endpoint is the time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization whichever occurs first.

Secondary Outcome Measures:
  • Time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
    Time to cardiovascular death, myocardial infarction, or stroke, whichever occurs first

  • Time to cardiovascular death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to cardiovascular death

  • Time to death by any cause [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to death by any cause

  • Time to first myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to first myocardial infarction

  • Time to first stroke [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to first stroke

  • Time to first coronary revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to first coronary revascularization

  • Time to cardiovascular death or first hospitalization for worsening heart failure, whichever occurs first [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to cardiovascular death or first hospitalization for worsening heart failure, whichever occurs first

  • Time to ischemic fatal or non-fatal stroke or TIA, whichever occurs first [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time to ischemic fatal or non-fatal stroke or TIA, whichever occurs first

Enrollment: 27564
Study Start Date:February 2013 Study Start Date Type:

Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Arm 1
Evolocumab (AMG 145) Q2W or QM plus effective statin dose
Biological/Vaccine: Evolocumab (AMG 145)
Evolocumab (AMG 145)
Drug: Effective statin therapy
Effective statin therapy defined as greater than or equal to atorvastatin 20 mg or an equivalent statin
Placebo Comparator: Arm 2
Placebo Q2W or QM plus effective statin dose
Other: Placebo
Placebo
Drug: Effective statin therapy
Effective statin therapy defined as greater than or equal to atorvastatin 20 mg or an equivalent statin


Eligibility

Ages Eligible for Study:  40 Years  to 85 Years
Genders Eligible for Study:  Both
Gender Based: 
Gender Eligibility Description: 
Accepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:
• Male or female ≥ 40 to ≤ 85 years of age
• History of clinically evident cardiovascular disease at high risk for a recurrent event
• Fasting LDL-C ≥ 70 mg/dL (≥ 1.8 mmol/L) ) or non-HDL-C ≥ 100 mg/dL (> 2.6 mmol/L)
• Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:
• NYHA class III or IV, or last known left ventricular ejection fraction < 30%
• Uncontrolled hypertension
• Uncontrolled or recurrent ventricular tachycardia
• Untreated hyperthyroidism or hypothyroidism
• Homozygous familial hypercholesterolemia
• LDL or plasma apheresis


Contacts and Locations

Contacts
Contact: Amgen Call Center 866-572-6436

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