Open Label Study of Long Term Evaluation Against LDL-C Trial-2 (OSLER-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01854918
First received: May 1, 2013
Last updated: October 1, 2015
Last verified: September 2015
  Purpose
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in subjects with hyperlipidemia and subjects with mixed dyslipidemia.

Condition Intervention Phase
Hyperlipidemia and Mixed Dyslipidemia
Biological: evolocumab (AMG 145) and standard of care
Other: Standard of care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145-2

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Subject incidence of adverse events [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: Weeks 48 & 104 ] [ Designated as safety issue: No ]
  • Change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: Weeks 48 & 104 ] [ Designated as safety issue: No ]

Enrollment: 3681
Study Start Date: April 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: evolocumab (AMG 145) and standard of care
evolocumab (AMG 145) and standard of care
Biological: evolocumab (AMG 145) and standard of care
evolocumab (AMG 145) is a fully human monoclonal antibody against PCSK9. Standard of care therapy is per local practice; this could include prescribed therapies and/or dietary/exercise regimes
Active Comparator: Standard of care
Standard of care therapy as per local practice
Other: Standard of care
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Complete a qualifying evolocumab (AMG 145) parent study

Exclusion Criteria:

  • Experienced a treatment-related serious adverse event that led to IP discontinuation in the parent study
  • Have an unstable medical condition, in the judgment of the investigator
  • Known sensitivity to any of the products to be administered during dosing
  • Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)
  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: NCT01854918

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United States, Alabama
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Birmingham, Alabama, United States, 35216
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Birmingham, Alabama, United States, 35294
United States, Arizona
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Chandler, Arizona, United States, 85224
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Phoenix, Arizona, United States, 85020
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Tucson, Arizona, United States, 85712
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
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Beverly Hills, California, United States, 90211
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Carmichael, California, United States, 95608
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Encinitas, California, United States, 92024
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Huntington Beach, California, United States, 92648
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Los Angeles, California, United States, 90048
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Mission Viejo, California, United States, 92691
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Newport Beach, California, United States, 92663
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San Diego, California, United States, 92111
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Thousand Oaks, California, United States, 91360
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Ventura, California, United States, 93003
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Littleton, Colorado, United States, 80120
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Daytona Beach, Florida, United States, 32117
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Jacksonville, Florida, United States, 32216
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Melbourne, Florida, United States, 32901
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Bethesda, Maryland, United States, 20817
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Ypsilanti, Michigan, United States, 48197
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Olive Branch, Mississippi, United States, 38654
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St Louis, Missouri, United States, 63110
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Henderson, Nevada, United States, 89052
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Raleigh, North Carolina, United States, 27609
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Fargo, North Dakota, United States, 58103
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Akron, Ohio, United States, 44311
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Duncansville, Pennsylvania, United States, 16635
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Renton, Washington, United States, 98057
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Tacoma, Washington, United States, 98405
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2015
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Maroubra, New South Wales, Australia, 2035
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Sydney, New South Wales, Australia, 2010
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Sydney, New South Wales, Australia, 2022
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Auchenflower, Queensland, Australia, 4066
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Heidelberg Heights, Victoria, Australia, 3081
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Cambridge, Ontario, Canada, N1R 6V6
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Brno, Czech Republic, 602 00
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Brno, Czech Republic, 603 00
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Chomutov, Czech Republic, 430 02
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Hradec Kralove, Czech Republic, 500 05
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Kladno, Czech Republic, 272 01
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Litomerice, Czech Republic, 412 01
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Moravske Budejovice, Czech Republic, 676 02
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Olomouc, Czech Republic, 775 20
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Pardubice, Czech Republic, 530 02
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Plzen, Czech Republic, 305 99
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Praha 2, Czech Republic, 128 08
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Praha 3, Czech Republic, 130 00
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Praha 4, Czech Republic, 140 21
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Slany, Czech Republic, 274 01
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Svitavy, Czech Republic, 568 25
Denmark
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Aalborg, Denmark, 9000
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Aarhus N, Denmark, 8200
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Ballerup, Denmark, 2750
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Vejle, Denmark, 7100
France
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Brest Cedex 2, France, 29200
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Bron, France, 69677
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Caen Cedex 9, France, 14033
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Dijon, France, 21034
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Montpellier cedex 05, France, 34295
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Nantes Cedex 1, France, 44093
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Paris Cedex 12, France, 75571
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Paris Cedex 13, France, 75651
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Vénissieux, France, 69200
Germany
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Bad Krozingen, Germany, 79189
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Berlin, Germany, 10787
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Berlin, Germany, 13353
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Berlin (Hellersdorf), Germany, 12627
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Dresden, Germany, 01307
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Heppenheim, Germany, 64646
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Homburg, Germany, 66421
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Köln, Germany, 50937
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Leipzig, Germany, 04103
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Magdeburg, Germany, 39112
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Messkirch, Germany, 88605
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München, Germany, 80638
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Witten, Germany, 58455
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Hong Kong, Hong Kong
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Hungary
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Baja, Hungary, 6500
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Berettyoujfalu, Hungary, 4100
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Budapest, Hungary, 1085
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Eger, Hungary, 3300
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Gyongyos, Hungary, 3200
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Hodmezovasarhely, Hungary, 6800
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Jaszbereny, Hungary, 5100
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Komarom, Hungary, 2921
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Szeged, Hungary, 6720
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Bologna, Italy, 40138
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Cagliari, Italy, 09134
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Chieti, Italy, 66100
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Ferrara, Italy, 44124
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Milano, Italy, 20162
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Napoli, Italy, 80131
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Padova, Italy, 35128
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Perugia, Italy, 06129
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Pisa, Italy, 56100
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Pisa, Italy, 56124
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Trieste, Italy, 34149
Japan
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Noda-shi, Chiba, Japan, 278-0004
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Fukuoka-shi, Fukuoka, Japan, 810-0014
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Fukuoka-shi, Fukuoka, Japan, 810-0066
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Fukuoka-shi, Fukuoka, Japan, 819-8551
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Kitakyusyu-shi, Fukuoka, Japan, 807-0856
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Koriyama-shi, Fukushima, Japan, 963-0209
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Koriyama-shi, Fukushima, Japan, 963-8026
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Koriyama-shi, Fukushima, Japan, 963-8041
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Koriyama-shi, Fukushima, Japan, 963-8862
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Koriyama-shi, Fukushima, Japan, 963-8832
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Maebashi-shi, Gunma, Japan, 371-0022
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Takasaki-shi, Gunma, Japan, 370-3524
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Sapporo-shi, Hokkaido, Japan, 003-0026
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Sapporo-shi, Hokkaido, Japan, 003-0825
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Sapporo-shi, Hokkaido, Japan, 060-0063
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Tsuchiura-shi, Ibaraki, Japan, 300-0047
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Morioka-shi, Iwate, Japan, 020-0066
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Takamatsu-shi, Kagawa, Japan, 760-0018
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Takamatsu-shi, Kagawa, Japan, 760-0076
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Yokohama-shi, Kanagawa, Japan, 231-0023
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Kyoto-shi, Kyoto, Japan, 615-8125
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Sendai-shi, Miyagi, Japan, 983-0835
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Sendai-shi, Miyagi, Japan, 989-3122
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Sendai-shi, Miyagi, Japan, 983-0039
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Tomigusuku-shi, Okinawa, Japan, 901-0243
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Ibaraki-shi, Osaka, Japan, 567-0876
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Toyonaka-shi, Osaka, Japan, 560-0082
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Koshigaya-shi, Saitama, Japan, 343-0828
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Niiza-shi, Saitama, Japan, 352-0014
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Arakawa-ku, Tokyo, Japan, 116-0002
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Chiyoda-ku, Tokyo, Japan, 101-0041
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Chofu-shi, Tokyo, Japan, 182-0006
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Edogawa-ku, Tokyo, Japan, 133-0061
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Hachioji-shi, Tokyo, Japan, 192-0046
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Katsushika-ku, Tokyo, Japan, 124-0024
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Koto-ku, Tokyo, Japan, 135-0011
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Minato-ku, Tokyo, Japan, 105-7390
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Minato-ku, Tokyo, Japan, 108-0075
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Ota-ku, Tokyo, Japan, 144-0034
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Setagaya-ku, Tokyo, Japan, 155-0031
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Shibuya-ku, Tokyo, Japan, 150-0012
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Shinagawa-ku, Tokyo, Japan, 140-0011
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Shinagawa-ku, Tokyo, Japan, 141-0001
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Shinagawa-ku, Tokyo, Japan, 141-6003
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Shinagawa-ku, Tokyo, Japan, 142-0053
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Toshima-ku, Tokyo, Japan, 171-0021
Korea, Republic of
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Seoul, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 135-710
Netherlands
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Amsterdam, Netherlands, 1105 AZ
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Den Helder, Netherlands, 1782 GZ
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Groningen, Netherlands, 9713 GZ
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Groningen, Netherlands, 9728 NT
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Hoogeveen, Netherlands, 7909 AA
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Hoorn, Netherlands, 1625 HV
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Nijmegen, Netherlands, 6525 EZ
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Rotterdam, Netherlands, 3045 PM
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Tilburg, Netherlands, 5022 GC
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Utrecht, Netherlands, 3584 CX
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Waalwijk, Netherlands, 5141 BM
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Zwijndrecht, Netherlands, 3331 LZ
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Christchurch, New Zealand, 8011
Norway
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Oslo, Norway, 0373
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Ålesund, Norway, 6003
Poland
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Lodz, Poland, 91-078
Russian Federation
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Barnaul, Russian Federation, 656055
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Kemerovo, Russian Federation, 650002
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Moscow, Russian Federation, 121552
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Novosibirsk, Russian Federation, 630047
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Saint Petersburg, Russian Federation, 197022
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Saratov, Russian Federation, 410054
South Africa
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Centurion, Gauteng, South Africa, 0157
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Johannesburg, Gauteng, South Africa, 2193
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Midrand, Gauteng, South Africa, 1685
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Sunninghill, Gauteng, South Africa, 2157
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Amanzimtoti, KwaZulu-Natal, South Africa, 4126
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Observatory, Western Cape, South Africa, 7925
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Paarl, Western Cape, South Africa, 7646
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Parow, Western Cape, South Africa, 7505
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Somerset West, Western Cape, South Africa, 7130
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Bloemfontein, South Africa, 9301
Spain
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Cordoba, Andalucía, Spain, 14004
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Zaragoza, Aragón, Spain, 50009
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L'Hospitalet de Llobregat, Cataluña, Spain, 08907
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Reus, Cataluña, Spain, 43204
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Madrid, Spain, 28007
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Madrid, Spain, 28029
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Madrid, Spain, 28040
Sweden
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Göteborg, Sweden, 413 45
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Lund, Sweden, 222 21
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Stockholm, Sweden, 171 45
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Stockholm, Sweden, 111 57
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Stockholm, Sweden, 141 86
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Uddevalla, Sweden, 451 50
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Örebro, Sweden, 701 46
Switzerland
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Bellinzona, Switzerland, 6500
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Geneva 14, Switzerland, 1211
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Lausanne, Switzerland, 1011
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Lugano, Switzerland, 6900
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Muensterlingen, Switzerland, 8596
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Reinach, Switzerland, 4153
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St. Gallen, Switzerland, 9007
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Zurich, Switzerland, 8091
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Zurich, Switzerland, 8063
Taiwan
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Kaohsiung, Taiwan, 83301
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Taipei, Taiwan, 100
United Kingdom
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Birmingham, United Kingdom, B15 2SQ
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Birmingham, United Kingdom, B15 2TH
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Blackpool, United Kingdom, FY3 7EN
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Cardiff, United Kingdom, CF14 5GJ
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Chesterfield, United Kingdom, S40 4AA
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Chorley, United Kingdom, PR7 7NA
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Coventry, United Kingdom, CV2 2DX
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Doncaster, United Kingdom, DN9 1EP
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Glasgow, United Kingdom, G12 8TA
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Glasgow, United Kingdom, G20 0SP
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Glasgow, United Kingdom, G45 9AW
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Liverpool, United Kingdom, L7 8XP
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Liverpool, United Kingdom, L22 0LG
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London, United Kingdom, NW3 2QG
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London, United Kingdom, SE1 7EH
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London, United Kingdom, W6 8RF
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Manchester, United Kingdom, M13 9WL
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Manchester, United Kingdom, M15 6SX
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Newcastle upon Tyne, United Kingdom, NE1 4LP
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Reading, United Kingdom, RG2 0TG
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Telford, United Kingdom, TF1 6TF
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Wakefield, United Kingdom, WF1 4DG
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West Bromwich, United Kingdom, B71 4HJ
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Whitby, United Kingdom, YO21 1SD
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01854918     History of Changes
Other Study ID Numbers: 20120138 
Study First Received: May 1, 2013
Last Updated: October 1, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Health and Medicines Authority
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
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
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Austria: Agency for Health and Food Safety
Italy: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Taiwan : Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare
China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 03, 2016