Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (GLAGOV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01813422
First received: March 15, 2013
Last updated: November 6, 2014
Last verified: October 2014
  Purpose

This study will evaluate whether low-density lipoprotein (LDL-C) lowering with Evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in subjects with coronary artery disease taking lipid lowering therapy.


Condition Intervention Phase
Hypercholesterolemia
Biological: Evolocumab (AMG 145)
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, 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.

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Nominal change in PAV from baseline to week 78 post randomization, as determined by intravascular ultrasound (IVUS) [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Regression (any reduction from baseline) in PAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Nominal change in total atheroma volume (TAV) from baseline to week 78 [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
  • Regression (any reduction from baseline) in TAV [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 950
Study Start Date: May 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Evolocumab (AMG 145)
Evolocumab (AMG 145)
Biological: Evolocumab (AMG 145)
Subjects randomized to the Evolocumab (AMG 145) arm will receive Evolocumab (AMG 145) subcutaneously every 4 weeks
Placebo Comparator: Placebo
Placebo
Other: Placebo
Subjects randomized to the placebo arm will receive Placebo subcutaneously every 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 40mm in length); cannot have undergone prior PCI or 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 MI.

Exclusion Criteria:

  • Coronary artery bypass graft surgery < 6 weeks prior to the qualifying IVUS
  • 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 (HbA1c > 9%) at screening.
  • Moderate to severe renal dysfunction (eGFR < 30 ml/min/1.73m2) at screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813422

Contacts
Contact: Amgen Call Center 866-572-6436

  Hide Study Locations
Locations
United States, Alabama
Research Site Recruiting
Huntsville, Alabama, United States, 35801
Research Site Recruiting
Moblie, Alabama, United States, 36608
United States, Arkansas
Research Site Completed
Little Rock, Arkansas, United States, 72211
United States, California
Research Site Recruiting
La Jolla, California, United States, 92093-0960
Research Site Recruiting
Long Beach, California, United States, 90822
Research Site Recruiting
Newport Beach, California, United States, 92663
Research Site Recruiting
Orange, California, United States, 92868
Research Site Recruiting
San Diego, California, United States, 92161
Research Site Recruiting
Santa Monica, California, United States, 90404
Research Site Recruiting
Torrance, California, United States, 90502
United States, District of Columbia
Research Site Recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Research Site Recruiting
Atlantis, Florida, United States, 33462
Research Site Recruiting
Clearwater, Florida, United States, 33756
Research Site Recruiting
Jacksonville, Florida, United States, 32209
Research Site Recruiting
Jacksonville, Florida, United States, 32216
Research Site Recruiting
Melbourne, Florida, United States, 32901
Research Site Recruiting
Safety Harbor, Florida, United States, 34695
United States, Georgia
Research Site Recruiting
Atlanta, Georgia, United States, 30342
United States, Indiana
Research Site Recruiting
Hammond, Indiana, United States, 46320
Research Site Recruiting
Valparaiso, Indiana, United States, 46383
United States, Kentucky
Research Site Recruiting
Lexington, Kentucky, United States, 40536
Research Site Recruiting
Louisville, Kentucky, United States, 40205
United States, Louisiana
Research Site Recruiting
Covington, Louisiana, United States, 70433
United States, Maryland
Research Site Recruiting
Bethesda, Maryland, United States, 20814
Research Site Recruiting
Columbia, Maryland, United States, 21044
United States, Michigan
Research Site Recruiting
Ann Arbor, Michigan, United States, 48109
Research Site Recruiting
Bay City, Michigan, United States, 48708
Research Site Recruiting
Marquette, Michigan, United States, 49855
Research Site Recruiting
Midland, Michigan, United States, 48670
Research Site Recruiting
Petoskey, Michigan, United States, 49770
Research Site Recruiting
Saginaw, Michigan, United States, 48601
United States, Minnesota
Research Site Completed
Duluth, Minnesota, United States, 55805
Research Site Recruiting
Duluth, Minnesota, United States, 55805
Research Site Recruiting
Minneapolis, Minnesota, United States, 55407
Research Site Recruiting
Saint Cloud, Minnesota, United States, 56303
Research Site Recruiting
Saint Paul, Minnesota, United States, 55102
United States, Missouri
Research Site Recruiting
Columbia, Missouri, United States, 65212
United States, Montana
Research Site Completed
Missoula, Montana, United States, 59802
United States, Nebraska
Research Site Recruiting
Omaha, Nebraska, United States, 68198
United States, New Jersey
Research Site Recruiting
Ridgewood, New Jersey, United States, 07450
United States, New York
Research Site Recruiting
Buffalo, New York, United States, 14215
Research Site Completed
Johnson City, New York, United States, 13790
United States, North Carolina
Research Site Recruiting
Charlotte, North Carolina, United States, 28204
United States, North Dakota
Research Site Recruiting
Fargo, North Dakota, United States, 58122
United States, Ohio
Research Site Recruiting
Canton, Ohio, United States, 44710
Research Site Recruiting
Elyria, Ohio, United States, 44035
Research Site Recruiting
Toledo, Ohio, United States, 43614
United States, Oklahoma
Research Site Recruiting
Oklahoma City, Oklahoma, United States, 73104
Research Site Completed
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Research Site Completed
Hillsboro, Oregon, United States, 97123
Research Site Completed
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Research Site Recruiting
Doylestown, Pennsylvania, United States, 18901
Research Site Recruiting
Hershey, Pennsylvania, United States, 17033
United States, Tennessee
Research Site Recruiting
Oak Ridge, Tennessee, United States, 37830
United States, Texas
Research Site Recruiting
Amarillo, Texas, United States, 79106
Research Site Recruiting
Dallas, Texas, United States, 75216
Research Site Recruiting
San Antonio, Texas, United States, 78229
Research Site Recruiting
Wichita Falls, Texas, United States, 76301
Argentina
Research Site Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1428DCO
Research Site Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
Research Site Recruiting
La Plata, Buenos Aires, Argentina, 1900
Research Site Recruiting
Cordoba, Córdoba, Argentina, X5016KEH
Research Site Recruiting
Cordoba, Córdoba, Argentina, X5000JHQ
Research Site Recruiting
Rosario, Santa Fe, Argentina, 2000
Research Site Recruiting
Buenos Aires, Argentina, C1280AEB
Research Site Recruiting
Corrientes, Argentina, W3400AMZ
Research Site Recruiting
Córdoba, Argentina, X5003DCE
Australia, New South Wales
Research Site Recruiting
Concord, New South Wales, Australia, 2139
Research Site Recruiting
Darlinghurst, New South Wales, Australia, 2010
Research Site Recruiting
Liverpool, New South Wales, Australia, 2170
Research Site Recruiting
New Lambton Heights, New South Wales, Australia, 2305
Australia, Queensland
Research Site Recruiting
Chermside, Queensland, Australia, 4032
Research Site Recruiting
Herston, Queensland, Australia, 4029
Australia, South Australia
Research Site Recruiting
Adelaide, South Australia, Australia, 5000
Research Site Recruiting
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Research Site Recruiting
Epping, Victoria, Australia, 3076
Research Site Recruiting
Footscray, Victoria, Australia, 3011
Research Site Completed
Heidelberg, Victoria, Australia, 3084
Research Site Recruiting
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Research Site Recruiting
Nedlands, Western Australia, Australia, 6009
Belgium
Research Site Recruiting
Antwerpen, Belgium, 2020
Research Site Recruiting
Brussels, Belgium, 1090
Research Site Completed
Bruxelles, Belgium, 1200
Research Site Recruiting
Edegem, Belgium, 2650
Research Site Recruiting
Genk, Belgium, 3600
Research Site Completed
Gent, Belgium, 9000
Research Site Recruiting
Hasselt, Belgium, 3500
Research Site Recruiting
Lodelinsart, Belgium, 6042
Brazil
Research Site Recruiting
Cariacica, Espírito Santo, Brazil, 29156-580
Research Site Recruiting
Curitiba, Paraná, Brazil, 80320-320
Research Site Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Research Site Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90620-001
Research Site Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Research Site Recruiting
Sao Paulo, São Paulo, Brazil, 04012-909
Research Site Recruiting
São Paulo, Brazil, 05403-000
Canada, Alberta
Research Site Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Research Site Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Research Site Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Research Site Recruiting
Victoria, British Columbia, Canada, V8R 4R2
Canada, Manitoba
Research Site Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
Research Site Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Research Site Recruiting
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Research Site Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Research Site Recruiting
London, Ontario, Canada, N6A 5A5
Research Site Recruiting
Toronto, Ontario, Canada, M5G 2C4
Research Site Recruiting
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Research Site Recruiting
Laval, Quebec, Canada, H7M 3L9
Research Site Recruiting
Montreal, Quebec, Canada, H3A 1A1
Research Site Recruiting
Montreal, Quebec, Canada, H1T 2M4
Research Site Recruiting
Montreal, Quebec, Canada, H4J 1C5
Research Site Recruiting
Quebec City, Quebec, Canada, G1V 4G5
Chile
Research Site Recruiting
Temuco, Cautín, Chile, 4781156
Research Site Recruiting
Santiago, Chile, 7650018
Research Site Recruiting
Santiago, Chile, 8330032
Research Site Recruiting
Santiago, Chile, 8207257
Czech Republic
Research Site Recruiting
Brno, Czech Republic, 625 00
Research Site Recruiting
Hradec Kralove, Czech Republic, 500 05
Research Site Recruiting
Praha 2, Czech Republic, 128 08
Research Site Completed
Praha 4, Czech Republic, 140 21
Research Site Completed
Usti nad Labem, Czech Republic, 401 13
Research Site Recruiting
Zlin, Czech Republic, 762 75
Denmark
Research Site Recruiting
Aarhus N, Denmark, 8200
Research Site Recruiting
Odense C, Denmark, 5000
France
Research Site Recruiting
Besançon Cedex, France, 25030
Research Site Recruiting
Chambray les Tours, France, 37170
Research Site Recruiting
Creteil, France, 94010
Research Site Recruiting
Marseille cedex 5, France, 13385
Research Site Recruiting
Paris, France, 75015
Research Site Recruiting
Pessac Cedex, France, 33604
Germany
Research Site Recruiting
Aachen, Germany, 52074
Research Site Recruiting
Essen, Germany, 45122
Research Site Recruiting
München, Germany, 81737
Research Site Recruiting
Neuss, Germany, 41464
Research Site Recruiting
Regensburg, Germany, 93053
Research Site Recruiting
Ulm, Germany, 89081
Greece
Research Site Completed
Alexandroupoli, Greece, 68100
Research Site Recruiting
Athens, Greece, 11527
Research Site Recruiting
Athens, Greece, 14561
Research Site Recruiting
Athens, Greece, 17674
Research Site Recruiting
Heraklion, Greece, 71110
Hungary
Research Site Recruiting
Budapest, Hungary, 1023
Research Site Recruiting
Budapest, Hungary, 1122
Research Site Recruiting
Budapest, Hungary, 1106
Research Site Recruiting
Budapest, Hungary, 1134
Research Site Recruiting
Debrecen, Hungary, 4032
Research Site Recruiting
Pecs, Hungary, 7624
Research Site Recruiting
Szeged, Hungary, 6725
Iceland
Research Site Recruiting
Reykjavik, Iceland, 101
Ireland
Research Site Recruiting
Dublin, Ireland, 8
Research Site Recruiting
Galway, Ireland
Israel
Research Site Recruiting
Askelon, Israel, 78278
Research Site Recruiting
Jerusalem, Israel, 91031
Research Site Recruiting
Nahariya, Israel, 22100
Research Site Recruiting
Rehovot, Israel, 76100
Italy
Research Site Recruiting
Novara, Italy, 28100
Research Site Recruiting
Roma, Italy, 00168
Research Site Recruiting
Rozzano MI, Italy, 20089
Research Site Recruiting
Sesto San Giovanni (MI), Italy, 20099
Research Site Recruiting
Torino, Italy, 10154
Korea, Republic of
Research Site Recruiting
Daejeon, Korea, Republic of, 301-723
Research Site Recruiting
Seongnam-si, Korea, Republic of, 463-707
Research Site Recruiting
Seoul, Korea, Republic of, 156-707
Research Site Recruiting
Seoul, Korea, Republic of, 130-872
Malaysia
Research Site Recruiting
Kuantan, Pahang, Malaysia, 25100
Research Site Recruiting
Penang, Malaysia, 10050
Mexico
Research Site Recruiting
Guadalajara, Jalisco, Mexico, 44670
Research Site Recruiting
Queretaro, Querétaro, Mexico, 76000
Research Site Recruiting
San Luis Potosi, San Luis Potosí, Mexico, 78240
Research Site Recruiting
Culiacan, Sinaloa, Mexico, 80020
Research Site Recruiting
Aguascalientes, Mexico, 20230
Research Site Recruiting
Puebla, Mexico, 72490
Netherlands
Research Site Recruiting
Alkmaar, Netherlands, 1815 JD
Research Site Recruiting
Amsterdam, Netherlands, 1081 HV
Research Site Recruiting
Amsterdam, Netherlands, 1091 AC
Research Site Recruiting
Eindhoven, Netherlands, 5623 EJ
Research Site Recruiting
Leeuwarden, Netherlands, 8934 AD
Research Site Recruiting
Nieuwegein, Netherlands, 3435 CM
Research Site Recruiting
Nijmegen, Netherlands, 6532 SZ
Research Site Recruiting
Rotterdam, Netherlands, 3079 DZ
Research Site Recruiting
Tilburg, Netherlands, 5042 AD
Research Site Recruiting
Utrecht, Netherlands, 3584 CX
Research Site Recruiting
Venlo, Netherlands, 5912 BL
Research Site Recruiting
Zwolle, Netherlands, 8025 AB
Norway
Research Site Recruiting
Oslo, Norway, 0424
Research Site Completed
Tromso, Norway, 9038
Philippines
Research Site Recruiting
Pasig City, Philippines, 1600
Research Site Recruiting
Quezon City, Philippines, 1100
Research Site Recruiting
Quezon City, Philippines, 1102
Poland
Research Site Recruiting
Chrzanow, Poland, 32-500
Research Site Recruiting
Kedzierzyn Kozle, Poland, 47-200
Research Site Recruiting
Krakow, Poland, 31-202
Research Site Recruiting
Krakow, Poland, 31-501
Research Site Recruiting
Lodz, Poland, 90-549
Research Site Recruiting
Warszawa, Poland, 04-628
Russian Federation
Research Site Recruiting
Kemerovo, Russian Federation, 650002
Research Site Recruiting
Moscow, Russian Federation, 121552
Research Site Recruiting
Moscow, Russian Federation, 101990
Research Site Recruiting
Moscow, Russian Federation, 199991
Singapore
Research Site Recruiting
Singapore, Singapore, 169609
South Africa
Research Site Recruiting
Boksburg, Gauteng, South Africa, 1470
Research Site Recruiting
Centurion, Gauteng, South Africa, 0157
Research Site Recruiting
Johannesburg, Gauteng, South Africa, 2157
Research Site Recruiting
Kuils River, Western Cape, South Africa, 7580
Research Site Recruiting
Pinelands, Cape Town, Western Cape, South Africa, 7405
Research Site Recruiting
Somerset West, Western Cape, South Africa, 7130
Spain
Research Site Recruiting
Malaga, Andalucía, Spain, 29010
Research Site Recruiting
Gijon, Asturias, Spain, 33394
Research Site Recruiting
Barcelona, Cataluña, Spain, 08035
Research Site Recruiting
L Hospitalet de Llobregat, Cataluña, Spain, 08907
Research Site Recruiting
Santiago de Compostela, Galicia, Spain, 15706
Research Site Recruiting
Madrid, Spain, 28046
Research Site Recruiting
Madrid, Spain, 28034
Sweden
Research Site Recruiting
Göteborg, Sweden, 413 45
Research Site Completed
Helsingborg, Sweden, 251 87
Research Site Recruiting
Lund, Sweden, 221 85
Research Site Recruiting
Solna, Sweden, 171 76
Research Site Recruiting
Stockholm, Sweden, 118 83
Research Site Recruiting
Örebro, Sweden, 701 85
Switzerland
Research Site Recruiting
Geneva 14, Switzerland, 1211
Research Site Recruiting
St. Gallen, Switzerland, 9007
Taiwan
Research Site Recruiting
Kaohsiung, Taiwan, 83301
Research Site Recruiting
Taichung City, Taiwan, 402
Research Site Recruiting
Taipei, Taiwan, 251
Research Site Recruiting
Taipei, Taiwan, 11217
United Kingdom
Research Site Recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01813422     History of Changes
Other Study ID Numbers: 20120153
Study First Received: March 15, 2013
Last Updated: November 6, 2014
Health Authority: Argentina: AMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica)
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: ANVISA (Agencia Nacional de Vigilancia Sanitária)
Canada: Health Canada
Chile: Instituto de Salud Publica
Czech Republic: State Institute for Drug Control
Denmark: Danish Health and Medicines Authority (Sundhedsstyrelsen)
Finland: Finnish Medicines Agency (Fimea)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Greece: National Drug Organization (NOF)
Hungary: National Institute of Pharmacy
Iceland: Icelandic Medicines Agency (Lyfjastofnun)
Ireland: Irish Medicines Board
Israel: Ministry of Health
Italy: Ministry of Health
Malaysia: Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency (Statens legemiddelverk)
Philippines : Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan: Taiwan Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Amgen:
Cholesterol
High Cholesterol
Elevated Cholesterol
Raised Cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014