Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER)

This study is currently recruiting participants.
Verified April 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01764633
First received: January 8, 2013
Last updated: April 9, 2014
Last verified: April 2014
  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
Device: Evolocumab (AMG 145)
Device: Placebo
Drug: Effective statin therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Amgen:

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

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

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

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


Estimated Enrollment: 22500
Study Start Date: January 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Evolocumab (AMG 145) Q2W or QM plus effective statin dose
Device: 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
Device: 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764633

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 1082 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01764633     History of Changes
Other Study ID Numbers: 20110118, 2014/01/004324
Study First Received: January 8, 2013
Last Updated: April 9, 2014
Health Authority: Argentina: ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Medica)
Brazil: ANVISA (Agencia Nacional de Vigilancia Sanitária)
Hong Kong: Department of Health
Phillipines: Food and Drug Administration
Malaysia: Ministry of Health
Singapore: Health Sciences Authority
South Korea: Korea Food & Drug Administration
Taiwan: Taiwan Food and Drug Administration
Czech Republic: State Institute for Drug Control (SUKL)
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines, National Institute of Pharmacy Directorate Clinical Trials Department
Poland: The office for registration of Medicinal Products, Medical Devices and Biocides
Slovakia: SUKL
Australia: Therapeutic Goods Administration (TGA)
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Paul-Ehrlich-Institut
New Zealand: MEDSAFE (New Zealand Medicines and Medical Devices Safety Authority)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Canada: Canadian Agency is Health Canada _ Biologics and Genetic Therapies Directorate.
United States: Food and Drug Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: Danish Health and Medicines Authority (Sundhedsstyrelsen)
Estonia: State Agency of Medicines (Ravimiamet)
Finland: Finnish Medicines Agency (Fimea)
Greece: National Drug Organization (EOF)
Iceland: Icelandic Medicines Agency (Lyfjastofnun)
Ireland: Irish Medicines Board
Latvia: State Agency of Medicines (Zāļu valsts aģentūra)
Lithuania: State Medicines Control Agency (Valstybinė vaistų kontrolės tarnyba prie Lietuvos Respublikos sveikatos apsaugos ministerijos)
Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO
Norway: Norwegian Medicines Agency (Statens legemiddelverk)
South Africa: MCC
Sweden: Medical Products Agency (Läkemedelsverket)
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Bulgara: Bulgarian Drug Agency
Romania: Ministry of Health, National Agency for Medicines and Medical Devices
Ukraine: State Expert Center of the Ministry of Health of Ukraine
Turkey: Ministry of Health, the Republic of Turkey
Chile: Instituto de Salud Pública
Mexico: Federal Commission for the Protection Against Sanitary Risks Sanitary of Health Agency
Israel: Israel Ministry of Health
Portugal: INFARMED, Autoridade Nacional do Medicamento e Produtos de Saúde I.P.
Russia: The Ministry of Healthcare of the Russian Federation
Austria: Bundesamt für Sicherheit im Gesundheitswesen-AGES Medizinmarktaufsicht-Institut Zulassung & LifeCycleManagement (LCM)-Abteilung Klinische Pruefung, Praeklinik & Statistik (KPPS)
Italy: Ministry of Health
India: Ministry of Health
China: China Food and Drug Administration (CFDA)
Columbia: Instituto Nacional de Vigilancia de Medicamentos y Alimentes

Keywords provided by Amgen:
High cholesterol
Treatment for high cholesterol
Lowering cholesterol
Lowering high cholesterol
Hypercholesterolemia

Additional relevant MeSH terms:
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014