Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk - Full Text View

Purpose

The primary hypothesis is that additional low-density lipoprotein cholesterol lowering with AMG 145 when used in addition to other treatment for dyslipidemia is well tolerated and decreases the aggregate 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: AMG 145 Device: Placebo Drug: Atorvastatin	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 AMG 145 is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Heart Attack

Drug Information available for: Atorvastatin calcium

U.S. FDA Resources

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 AMG 145 Q2W or QM plus Atorvastatin with or without ezetimibe if at the highest approved atorvastatin dose	Device: AMG 145 AMG 145 Drug: Atorvastatin Atorvastatin to maximally tolerated dose between 20 mg to 80 mg
Placebo Comparator: Arm 2 Placebo Q2W or QM plus Atorvastatin with or without ezetimibe if at the highest approved atorvastatin dose	Device: Placebo Placebo Drug: Atorvastatin Atorvastatin to maximally tolerated dose between 20 mg to 80 mg

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
Uncontrolled 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 637 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01764633 History of Changes
Other Study ID Numbers:	20110118
Study First Received:	January 8, 2013
Last Updated:	April 18, 2013
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 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

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
Atorvastatin
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 May 16, 2013

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