Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
NCT ID: NCT01375764
Last Updated: 2022-11-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2011-07-28
2012-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ezetimibe
Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
Ezetimibe
Administered orally once a day
Placebo to Evolocumab
Administered by subcutaneous injection
Evolocumab + Ezetimibe
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Ezetimibe
Administered orally once a day
Evolocumab 280 mg
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Evolocumab 350 mg
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Evolocumab 420 mg
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab
Administered by subcutaneous injection
Interventions
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Evolocumab
Administered by subcutaneous injection
Ezetimibe
Administered orally once a day
Placebo to Evolocumab
Administered by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On a statin or a low dose statin with stable dose for at least 4 weeks
* Lipid lowering therapy has been stable prior to enrollment
* Fasting triglycerides must be \< 400 mg/dL.
* Subject not at LDL-C goal
Exclusion Criteria
* Uncontrolled cardiac arrhythmia
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
* Type 1 diabetes or newly diagnosed type 2 diabetes (HbA1c \> 8.5%)
* Uncontrolled hypertension
18 Years
75 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Anaheim, California, United States
Research Site
Mission Viejo, California, United States
Research Site
Westlake Village, California, United States
Research Site
Atlanta, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Savannah, Georgia, United States
Research Site
Auburn, Maine, United States
Research Site
Chevy Chase, Maryland, United States
Research Site
Butte, Montana, United States
Research Site
Henderson, Nevada, United States
Research Site
Las Vegas, Nevada, United States
Research Site
New York, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Akron, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Bristol, Tennessee, United States
Research Site
Camperdown, New South Wales, Australia
Research Site
Sydney, New South Wales, Australia
Research Site
Melbourne, Victoria, Australia
Research Site
Perth, Western Australia, Australia
Research Site
Brussels, , Belgium
Research Site
Uccle, , Belgium
Research Site
Saint John’s, Newfoundland and Labrador, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Lachine, Quebec, Canada
Research Site
Ballerup Municipality, , Denmark
Research Site
Vejle, , Denmark
Research Site
Helsinki, , Finland
Research Site
OYS, , Finland
Research Site
Zaragoza, Aragon, Spain
Research Site
Zaragoza, Aragón, Spain
Research Site
Barcelona, Catalonia, Spain
Research Site
L'Hospitalet de Llobregat, Catalonia, Spain
Research Site
Reus, Catalonia, Spain
Research Site
Barcelona, Cataluña, Spain
Research Site
L'Hospitalet de Llobregat, Cataluña, Spain
Research Site
Reus, Cataluña, Spain
Research Site
Göteborg, , Sweden
Research Site
Gothenburg, , Sweden
Research Site
Lund, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Stockholm, , Sweden
Countries
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References
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Sullivan D, Olsson AG, Scott R, Kim JB, Xue A, Gebski V, Wasserman SM, Stein EA. Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: the GAUSS randomized trial. JAMA. 2012 Dec 19;308(23):2497-506. doi: 10.1001/jama.2012.25790.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20090159
Identifier Type: -
Identifier Source: org_study_id
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