GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (GLAGOV)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01813422 |
Recruitment Status
:
Completed
First Posted
: March 19, 2013
Results First Posted
: January 4, 2018
Last Update Posted
: February 5, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypercholesterolemia | Biological: Evolocumab Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 970 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization |
Actual Study Start Date : | April 18, 2013 |
Actual Primary Completion Date : | July 12, 2016 |
Actual Study Completion Date : | July 29, 2016 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
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Drug: Placebo
Administered by subcutaneous injection
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Experimental: Evolocumab
Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
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Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
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- Change From Baseline in Percent Atheroma Volume at Week 78 [ Time Frame: Baseline and week 78 ]Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.
- Change From Baseline in Total Atheroma Volume at Week 78 [ Time Frame: Baseline and week 78 ]Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.
- Percentage of Participants With Regression in Percent Atheroma Volume [ Time Frame: Baseline and week 78 ]
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.
Regression in PAV was defined as any reduction from baseline in PAV.
- Percentage of Participants With Regression in Total Atheroma Volume [ Time Frame: Baseline and week 78 ]
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.
Regression in TAV was defined as any reduction from baseline in TAV.

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical indication for coronary angiography
- Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria
- Fasting LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C ≥ 60 -< 80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors
Subjects must meet the following criteria at the qualifying coronary catheterization procedure:
- Evidence of coronary heart disease (at least one lesion in a native coronary artery that has > 20% reduction in lumen diameter) or prior percutaneous intervention (PCI)
- Left main coronary artery < 50% reduction in lumen diameter by visual estimation
- Target coronary artery for IVUS must be accessible to the IVUS catheter, must not have a > 50% reduction in lumen diameter within the target segment (and at least 40 mm in length); cannot have undergone prior PCI or coronary artery bypass graft (CABG) and is not a candidate for intervention over the next 18 months. It may not be a bypass graft, bypassed vessel or culprit vessel for previous myocardial infarction (MI).
Exclusion Criteria:
- Coronary artery bypass graft surgery < 6 weeks prior to the qualifying IVUS
- New York Heart Association (NYHA) III or IV heart failure, or last known left ventricular ejection fraction less than 30%
- Uncontrolled cardiac arrhythmia that is not controlled by medications in the 3 months prior to randomization
- Known hemorrhagic stroke
- Uncontrolled hypertension at randomization
- Fasting Triglycerides ≥ 400 mg/dL (4.5 mmol/L) at screening
- Type 1 diabetes or poorly controlled type 2 diabetes (hemoglobin A1c [HbA1c] > 9%) at screening.
- Moderate to severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m²) at screening.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813422

United States, Alabama | |
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Huntsville, Alabama, United States, 35801 | |
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Mobile, Alabama, United States, 36608 | |
United States, Arkansas | |
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Little Rock, Arkansas, United States, 72211 | |
United States, California | |
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La Jolla, California, United States, 92037 | |
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La Jolla, California, United States, 92093-0960 | |
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Long Beach, California, United States, 90822 | |
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Newport Beach, California, United States, 92663 | |
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Orange, California, United States, 92868 | |
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San Diego, California, United States, 92161 | |
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Santa Monica, California, United States, 90404 | |
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Torrance, California, United States, 90502 | |
United States, District of Columbia | |
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Washington, District of Columbia, United States, 20010 | |
United States, Florida | |
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Atlantis, Florida, United States, 33462 | |
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Clearwater, Florida, United States, 33756 | |
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Jacksonville, Florida, United States, 32209 | |
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Jacksonville, Florida, United States, 32216 | |
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Melbourne, Florida, United States, 32901 | |
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Safety Harbor, Florida, United States, 34695 | |
United States, Georgia | |
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Atlanta, Georgia, United States, 30342 | |
United States, Indiana | |
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Hammond, Indiana, United States, 46320 | |
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Valparaiso, Indiana, United States, 46383 | |
United States, Kentucky | |
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Lexington, Kentucky, United States, 40536 | |
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Louisville, Kentucky, United States, 40205 | |
United States, Louisiana | |
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Covington, Louisiana, United States, 70433 | |
United States, Maryland | |
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Bethesda, Maryland, United States, 20814 | |
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Columbia, Maryland, United States, 21044 | |
United States, Michigan | |
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Ann Arbor, Michigan, United States, 48109 | |
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Bay City, Michigan, United States, 48708 | |
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Grand Rapids, Michigan, United States, 49503 | |
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Marquette, Michigan, United States, 49855 | |
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Midland, Michigan, United States, 48670 | |
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Petoskey, Michigan, United States, 49770 | |
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Saginaw, Michigan, United States, 48601 | |
United States, Minnesota | |
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Duluth, Minnesota, United States, 55805 | |
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Minneapolis, Minnesota, United States, 55407 | |
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Saint Cloud, Minnesota, United States, 56303 | |
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Saint Paul, Minnesota, United States, 55102 | |
United States, Missouri | |
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Columbia, Missouri, United States, 65212 | |
United States, Montana | |
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Missoula, Montana, United States, 59802 | |
United States, Nebraska | |
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Omaha, Nebraska, United States, 68198 | |
United States, New Jersey | |
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Ridgewood, New Jersey, United States, 07450 | |
United States, New York | |
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Buffalo, New York, United States, 14215 | |
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Johnson City, New York, United States, 13790 | |
United States, North Carolina | |
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Charlotte, North Carolina, United States, 28204 | |
United States, North Dakota | |
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Fargo, North Dakota, United States, 58122 | |
United States, Ohio | |
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Canton, Ohio, United States, 44710 | |
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Elyria, Ohio, United States, 44035 | |
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Toledo, Ohio, United States, 43614 | |
United States, Oklahoma | |
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Oklahoma City, Oklahoma, United States, 73104 | |
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Tulsa, Oklahoma, United States, 74104 | |
United States, Oregon | |
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Hillsboro, Oregon, United States, 97123 | |
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Springfield, Oregon, United States, 97477 | |
United States, Pennsylvania | |
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Doylestown, Pennsylvania, United States, 18901 | |
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Hershey, Pennsylvania, United States, 17033 | |
United States, Tennessee | |
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Oak Ridge, Tennessee, United States, 37830 | |
United States, Texas | |
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Amarillo, Texas, United States, 79106 | |
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Dallas, Texas, United States, 75216 | |
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San Antonio, Texas, United States, 78229 | |
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Wichita Falls, Texas, United States, 76301 | |
Argentina | |
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB | |
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1428DCO | |
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La Plata, Buenos Aires, Argentina, 1900 | |
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Cordoba, Córdoba, Argentina, X5000JHQ | |
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Cordoba, Córdoba, Argentina, X5016KEH | |
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Rosario, Santa Fe, Argentina, 2000 | |
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Buenos Aires, Argentina, C1280AEB | |
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Corrientes, Argentina, W3400AMZ | |
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Córdoba, Argentina, X5003DCE | |
Australia, New South Wales | |
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Concord, New South Wales, Australia, 2139 | |
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Darlinghurst, New South Wales, Australia, 2010 | |
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Liverpool, New South Wales, Australia, 2170 | |
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New Lambton Heights, New South Wales, Australia, 2305 | |
Australia, Queensland | |
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Chermside, Queensland, Australia, 4032 | |
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Herston, Queensland, Australia, 4029 | |
Australia, South Australia | |
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Adelaide, South Australia, Australia, 5000 | |
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Bedford Park, South Australia, Australia, 5042 | |
Australia, Victoria | |
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Epping, Victoria, Australia, 3076 | |
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Footscray, Victoria, Australia, 3011 | |
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Heidelberg, Victoria, Australia, 3084 | |
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Melbourne, Victoria, Australia, 3004 | |
Australia, Western Australia | |
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Nedlands, Western Australia, Australia, 6009 | |
Belgium | |
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Antwerpen, Belgium, 2020 | |
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Brussels, Belgium, 1090 | |
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Bruxelles, Belgium, 1200 | |
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Edegem, Belgium, 2650 | |
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Genk, Belgium, 3600 | |
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Gent, Belgium, 9000 | |
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Hasselt, Belgium, 3500 | |
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Lodelinsart, Belgium, 6042 | |
Brazil | |
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Cariacica, Espírito Santo, Brazil, 29156-580 | |
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Goiania, Goiás, Brazil, 74223-130 | |
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Curitiba, Paraná, Brazil, 80320-320 | |
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Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090 | |
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000 | |
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Porto Alegre, Rio Grande Do Sul, Brazil, 90620-001 | |
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Sao Paulo, São Paulo, Brazil, 04012-909 | |
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São Paulo, Brazil, 05403-000 | |
Canada, Alberta | |
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Calgary, Alberta, Canada, T2N 4Z6 | |
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Edmonton, Alberta, Canada, T5H 3V9 | |
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Edmonton, Alberta, Canada, T6G 2B7 | |
Canada, British Columbia | |
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Victoria, British Columbia, Canada, V8R 4R2 | |
Canada, Manitoba | |
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Winnipeg, Manitoba, Canada, R2H 2A6 | |
Canada, New Brunswick | |
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Saint John, New Brunswick, Canada, E2L 4L2 | |
Canada, Newfoundland and Labrador | |
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St. Johns, Newfoundland and Labrador, Canada, A1B 3V6 | |
Canada, Nova Scotia | |
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Halifax, Nova Scotia, Canada, B3H 3A7 | |
Canada, Ontario | |
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London, Ontario, Canada, N6A 5A5 | |
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Toronto, Ontario, Canada, M5B 1W8 | |
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Toronto, Ontario, Canada, M5G 2C4 | |
Canada, Quebec | |
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Laval, Quebec, Canada, H7M 3L9 | |
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Montreal, Quebec, Canada, H1T 2M4 | |
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Montreal, Quebec, Canada, H3A 1A1 | |
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Montreal, Quebec, Canada, H4J 1C5 | |
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Quebec City, Quebec, Canada, G1V 4G5 | |
Chile | |
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Temuco, Cautín, Chile, 4781156 | |
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Santiago, Chile, 7650018 | |
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Santiago, Chile, 8207257 | |
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Santiago, Chile, 8330032 | |
Czechia | |
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Brno, Czechia, 625 00 | |
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Hradec Kralove, Czechia, 500 05 | |
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Praha 2, Czechia, 128 08 | |
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Praha 4, Czechia, 140 21 | |
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Usti nad Labem, Czechia, 401 13 | |
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Zlin, Czechia, 762 75 | |
Denmark | |
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Aarhus N, Denmark, 8200 | |
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Odense C, Denmark, 5000 | |
France | |
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Besançon Cedex, France, 25030 | |
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Chambray les Tours, France, 37170 | |
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Creteil, France, 94010 | |
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Marseille cedex 5, France, 13385 | |
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Paris, France, 75015 | |
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Pessac Cedex, France, 33604 | |
Germany | |
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Aachen, Germany, 52074 | |
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Essen, Germany, 45122 | |
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München, Germany, 81737 | |
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Neuss, Germany, 41464 | |
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Regensburg, Germany, 93053 | |
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Ulm, Germany, 89081 | |
Greece | |
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Alexandroupoli, Greece, 68100 | |
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Athens, Greece, 11527 | |
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Athens, Greece, 14561 | |
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Athens, Greece, 17674 | |
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Heraklion, Greece, 71110 | |
Hungary | |
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Budapest, Hungary, 1023 | |
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Budapest, Hungary, 1106 | |
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Budapest, Hungary, 1122 | |
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Budapest, Hungary, 1134 | |
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Debrecen, Hungary, 4032 | |
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Pecs, Hungary, 7624 | |
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Szeged, Hungary, 6725 | |
Iceland | |
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Reykjavik, Iceland, 101 | |
Ireland | |
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Dublin, Ireland, 8 | |
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Galway, Ireland | |
Israel | |
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Hadera, Israel, 38100 | |
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Jerusalem, Israel, 91031 | |
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Rehovot, Israel, 76100 | |
Italy | |
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Milan, Italy, 20099 | |
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Novara, Italy, 28100 | |
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Roma, Italy, 00168 | |
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Rozzano MI, Italy, 20089 | |
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Torino, Italy, 10154 | |
Korea, Republic of | |
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Daejeon, Korea, Republic of, 301-723 | |
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Seongnam-si, Korea, Republic of, 463-707 | |
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Seoul, Korea, Republic of, 130-872 | |
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Seoul, Korea, Republic of, 156-707 | |
Malaysia | |
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Kuantan, Pahang, Malaysia, 25100 | |
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George Town, Penang, Malaysia, 10050 | |
Mexico | |
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Guadalajara, Jalisco, Mexico, 44670 | |
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Queretaro, Querétaro, Mexico, 76000 | |
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San Luis Potosi, San Luis Potosí, Mexico, 78240 | |
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Culiacan, Sinaloa, Mexico, 80020 | |
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Aguascalientes, Mexico, 20230 | |
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Puebla, Mexico, 72490 | |
Netherlands | |
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Alkmaar, Netherlands, 1815 JD | |
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Amsterdam, Netherlands, 1081 HV | |
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Amsterdam, Netherlands, 1091 AC | |
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Eindhoven, Netherlands, 5623 EJ | |
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Leeuwarden, Netherlands, 8934 AD | |
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Nieuwegein, Netherlands, 3435 CM | |
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Nijmegen, Netherlands, 6532 SZ | |
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Rotterdam, Netherlands, 3079 DZ | |
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Tilburg, Netherlands, 5042 AD | |
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Utrecht, Netherlands, 3584 CX | |
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Venlo, Netherlands, 5912 BL | |
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Zwolle, Netherlands, 8025 AB | |
Norway | |
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Oslo, Norway, 0424 | |
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Tromso, Norway, 9038 | |
Philippines | |
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Pasig City, Philippines, 1600 | |
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Quezon City, Philippines, 1100 | |
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Quezon City, Philippines, 1102 | |
Poland | |
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Chrzanow, Poland, 32-500 | |
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Kedzierzyn Kozle, Poland, 47-200 | |
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Krakow, Poland, 31-202 | |
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Krakow, Poland, 31-501 | |
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Lodz, Poland, 90-549 | |
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Warszawa, Poland, 04-628 | |
Russian Federation | |
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Kemerovo, Russian Federation, 650002 | |
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Moscow, Russian Federation, 101990 | |
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Moscow, Russian Federation, 119991 | |
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Moscow, Russian Federation, 121552 | |
Singapore | |
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Singapore, Singapore, 169609 | |
South Africa | |
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Boksburg, Gauteng, South Africa, 1470 | |
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Centurion, Gauteng, South Africa, 0157 | |
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Johannesburg, Gauteng, South Africa, 2157 | |
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Cape Town, Western Cape, South Africa, 7405 | |
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Kuils River, Western Cape, South Africa, 7580 | |
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Somerset West, Western Cape, South Africa, 7130 | |
Spain | |
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Malaga, Andalucía, Spain, 29010 | |
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Gijon, Asturias, Spain, 33394 | |
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Barcelona, Cataluña, Spain, 08035 | |
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Barcelona, Cataluña, Spain, 08907 | |
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Santiago de Compostela, Galicia, Spain, 15706 | |
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Madrid, Spain, 28034 | |
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Madrid, Spain, 28046 | |
Sweden | |
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Göteborg, Sweden, 413 45 | |
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Helsingborg, Sweden, 251 87 | |
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Lund, Sweden, 221 85 | |
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Solna, Sweden, 171 76 | |
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Stockholm, Sweden, 118 83 | |
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Örebro, Sweden, 701 85 | |
Switzerland | |
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Geneva 14, Switzerland, 1211 | |
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St. Gallen, Switzerland, 9007 | |
Taiwan | |
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Kaohsiung, Taiwan, 83301 | |
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New Taipei, Taiwan, 251 | |
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Taichung City, Taiwan, 402 | |
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Taipei, Taiwan, 11217 | |
United Kingdom | |
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Newcastle Upon Tyne, United Kingdom, NE7 7DN |
Study Director: | MD | Amgen |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT01813422 History of Changes |
Other Study ID Numbers: |
20120153 2012-004208-37 ( EudraCT Number ) |
First Posted: | March 19, 2013 Key Record Dates |
Results First Posted: | January 4, 2018 |
Last Update Posted: | February 5, 2018 |
Last Verified: | January 2018 |
Keywords provided by Amgen:
Cholesterol High Cholesterol Elevated Cholesterol Raised Cholesterol |
Additional relevant MeSH terms:
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |