Hyperlipidemia and Mixed DyslipidemiaPhase 3OSLER-2NCT01854918

Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia

A Phase 3 study testing Evolocumab in people with Hyperlipidemia and Mixed Dyslipidemia, run by Amgen at 363 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Hyperlipidemia and Mixed Dyslipidemia
What is being tested?: Evolocumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,681 participants
Where: 363 sitesin 25 countries
Study dates: 23 Apr 2013to 31 May 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114 [NCT01763827], 20110115 [NCT01763866], 20110116 [NCT01763905], 20110117 [NCT01763918], 20110109 [NCT01516879], 20120122 [NCT01953328], 20120332 [NCT01984424], 20120348 [NCT01849497], or 20120356 [NCT01879319]).

Who cannot join

Experienced a treatment-related serious adverse event that led to study drug 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)

Trial locations and contacts

363 sites in 25 countries.

Country

City, postcode or hospital

363 sites in 25 countries

United States107 sites

Research Site
Akron, Ohio, 44311
Research Site
Anderson, South Carolina, 29621
Research Site
Atlanta, Georgia, 30328
Research Site
Atlanta, Georgia, 30338
Research Site
Atlanta, Georgia, 30342
Research Site
Auburn, Maine, 04210
Research Site
Austin, Texas, 78731
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Ayer, Massachusetts, 01432
Research Site
Bangor, Maine, 04401
Research Site
Bethesda, Maryland, 20817
Research Site
Beverly Hills, California, 90211
Research Site
Birmingham, Alabama, 35216
Research Site
Birmingham, Alabama, 35294
Research Site
Cadiz, Ohio, 43907
Research Site
Canton, Ohio, 44710
Research Site
Carmichael, California, 95608
Research Site
Chandler, Arizona, 85224
Research Site
Charleston, South Carolina, 29425
Research Site
Chicago, Illinois, 60654
Research Site
Cincinnati, Ohio, 45219
Research Site
Cincinnati, Ohio, 45227
Research Site
Cincinnati, Ohio, 45236
Research Site
Cleveland, Ohio, 44195
Research Site
Columbia, Maryland, 21045
Research Site
Dallas, Texas, 75230
Research Site
Dallas, Texas, 75231
Research Site
Dayton, Ohio, 45414
Research Site
Daytona Beach, Florida, 32117
Research Site
DeLand, Florida, 32720
Research Site
Duncansville, Pennsylvania, 16635
Research Site
Edina, Minnesota, 55435
Research Site
Encinitas, California, 92024
Research Site
Endwell, New York, 13760
Research Site
Fargo, North Dakota, 58103
Research Site
Gainesville, Georgia, 30501
Research Site
Henderson, Nevada, 89052
Research Site
Hillsboro, Oregon, 97123
Research Site
Houston, Texas, 77030
Research Site
Houston, Texas, 77074
Research Site
Huntington Beach, California, 92648
Research Site
Indianapolis, Indiana, 46260
Research Site
Iowa City, Iowa, 52242
Research Site
Jackson, Tennessee, 38305
Research Site
Jacksonville, Florida, 32216
Research Site
Kansas City, Kansas, 66160
Research Site
Lansdale, Pennsylvania, 19446
Research Site
Las Vegas, Nevada, 89148
Research Site
Lexington, Kentucky, 40504
Research Site
Little Rock, Arkansas, 72205
Research Site
Littleton, Colorado, 80120
Research Site
Los Angeles, California, 90048
Research Site
Louisville, Kentucky, 40213
Research Site
Manlius, New York, 13104
Research Site
Mansfield, Ohio, 44906
Research Site
Marion, Ohio, 43302
Research Site
Melbourne, Florida, 32901
Research Site
Miami, Florida, 33144
Research Site
Miami, Florida, 33173
Research Site
Mission Viejo, California, 92691
Research Site
Monroe, Louisiana, 71201
Research Site
Mt. Pleasant, South Carolina, 29464
Research Site
Munster, Indiana, 46321
Research Site
Nashville, Tennessee, 37203
Research Site
New Windsor, New York, 12553
Research Site
New York, New York, 10029
Research Site
Newport Beach, California, 92663
Research Site
Norfolk, Virginia, 23502
Research Site
Norman, Oklahoma, 73069
Research Site
Oklahoma City, Oklahoma, 73103
Research Site
Olive Branch, Mississippi, 38654
Research Site
Phoenix, Arizona, 85020
Research Site
Pittsburgh, Pennsylvania, 15216
Research Site
Ponte Vedra, Florida, 32081
Research Site
Port Charlotte, Florida, 33952
Research Site
Portland, Maine, 04101
Research Site
Quincy, Massachusetts, 02169
Research Site
Raleigh, North Carolina, 27609
Research Site
Raleigh, North Carolina, 27612
Research Site
Rapid City, South Dakota, 57701
Research Site
Rapid City, South Dakota, 57702
Research Site
Renton, Washington, 98057
Research Site
Richmond, Virginia, 23294
Research Site
Rochester, New York, 14609
Research Site
San Antonio, Texas, 78229
Research Site
San Diego, California, 92111
Research Site
Sandusky, Ohio, 44870
Research Site
Sanford, Florida, 32771
Research Site
Santa Ana, California, 92705
Research Site
Santa Rosa, California, 95405
Research Site
Savannah, Georgia, 31406
Research Site
Seattle, Washington, 98104
Research Site
Spring Valley, California, 91978
Research Site
St Louis, Missouri, 63110
Research Site
Sterling, Illinois, 61081
Research Site
Suffolk, Virginia, 23435
Research Site
Tacoma, Washington, 98405
Research Site
Thousand Oaks, California, 91360
Research Site
Torrance, California, 90509
Research Site
Towson, Maryland, 21204
Research Site
Tucson, Arizona, 85712
Research Site
Tupelo, Mississippi, 38801
Research Site
Tustin, California, 92780
Research Site
Ventura, California, 93003
Research Site
Williamsville, New York, 14221
Research Site
Winston-Salem, North Carolina, 27103
Research Site
York, Pennsylvania, 17405
Research Site
Ypsilanti, Michigan, 48197

Other trials in United States

Japan46 sites

Research Site
Arakawa-ku, Tokyo, 116-0002
Research Site
Chiyoda-ku, Tokyo, 101-0041
Research Site
Chofu-shi, Tokyo, 182-0006
Research Site
Edogawa-ku, Tokyo, 133-0061
Research Site
Fukuoka, Fukuoka, 810-0014
Research Site
Fukuoka, Fukuoka, 810-0066
Research Site
Fukuoka, Fukuoka, 819-8551
Research Site
Hachioji-shi, Tokyo, 192-0046
Research Site
Ibaraki-shi, Osaka, 567-0876
Research Site
Katsushika-ku, Tokyo, 124-0024
Research Site
Kitakyusyu-shi, Fukuoka, 807-0856
Research Site
Koriyama-shi, Fukushima, 963-0209
Research Site
Koriyama-shi, Fukushima, 963-8026
Research Site
Koriyama-shi, Fukushima, 963-8041
Research Site
Koriyama-shi, Fukushima, 963-8832
Research Site
Koriyama-shi, Fukushima, 963-8862
Research Site
Koshigaya-shi, Saitama, 343-0828
Research Site
Koto-ku, Tokyo, 135-0011
Research Site
Kyoto, Kyoto, 615-8125
Research Site
Maebashi, Gunma, 371-0022
Research Site
Minato-ku, Tokyo, 105-7390
Research Site
Minato-ku, Tokyo, 108-0075
Research Site
Morioka, Iwate, 020-0066
Research Site
Niiza-shi, Saitama, 352-0014
Research Site
Noda, Chiba, 278-0004
Research Site
Ōta-ku, Tokyo, 144-0034
Research Site
Sapporo, Hokkaido, 003-0026
Research Site
Sapporo, Hokkaido, 003-0825
Research Site
Sapporo, Hokkaido, 060-0063
Research Site
Sendai, Miyagi, 983-0039
Research Site
Sendai, Miyagi, 983-0835
Research Site
Sendai, Miyagi, 989-3122
Research Site
Setagaya-ku, Tokyo, 155-0031
Research Site
Shibuya-ku, Tokyo, 150-0012
Research Site
Shinagawa-ku, Tokyo, 140-0011
Research Site
Shinagawa-ku, Tokyo, 141-0001
Research Site
Shinagawa-ku, Tokyo, 141-6003
Research Site
Shinagawa-ku, Tokyo, 142-0053
Research Site
Takamatsu, Kagawa-ken, 760-0018
Research Site
Takamatsu, Kagawa-ken, 760-0076
Research Site
Takasaki-shi, Gunma, 370-3524
Research Site
Tomigusuku-shi, Okinawa, 901-0243
Research Site
Toshima-ku, Tokyo, 171-0021
Research Site
Toyonaka-shi, Osaka, 560-0082
Research Site
Tsuchiura-shi, Ibaraki, 300-0047
Research Site
Yokohama, Kanagawa, 231-0023

Other trials in Japan

Canada28 sites

Research Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0
Research Site
Burnaby, British Columbia, V5G 1T4
Research Site
Cambridge, Ontario, N1R 6V6
Research Site
Chicoutimi, Quebec, G7H 7K9
Research Site
Granby, Quebec, J2G 8Z9
Research Site
Greenfield Park, Quebec, J4V 2G8
Research Site
Hamilton, Ontario, L8L 2X2
Research Site
Kelowna, British Columbia, V1Y 1V6
Research Site
Lachine, Quebec, H8S 2E4
Research Site
London, Ontario, N5W 6A2
Research Site
London, Ontario, N6A 5K8
Research Site
Montreal, Quebec, H2W 1R7
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Montreal, Quebec, H3A 1A1
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Montreal, Quebec, H4N 2W2
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Mount Pearl, Newfoundland and Labrador, A1N 1W7
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Newmarket, Ontario, L3Y 5G8
Research Site
Oshawa, Ontario, L1J 2K1
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Peterborough, Ontario, K9J 0B2
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Pointe-Claire, Quebec, H9R 3J1
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Québec, Quebec, G1V 4M6
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Sarnia, Ontario, N7T 4X3
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St. John's, Newfoundland and Labrador, A1A 3R5
Research Site
Surrey, British Columbia, V3V 1N1
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Toronto, Ontario, M8V 3X8
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Toronto, Ontario, M9V 4B4
Research Site
Toronto, Ontario, M9W 4L6
Research Site
Vancouver, British Columbia, V6Z 1Y6
Research Site
Woodstock, Ontario, N4S 5P5

Other trials in Canada

United Kingdom24 sites

Research Site
Birmingham, B15 2SQ
Research Site
Birmingham, B15 2TH
Research Site
Blackpool, FY3 7EN
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Cardiff, CF14 5GJ
Research Site
Chesterfield, S40 4AA
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Chorley, PR7 7NA
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Coventry, CV2 2DX
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Doncaster, DN9 1EP
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Glasgow, G12 8TA
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Glasgow, G20 0SP
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Glasgow, G45 9AW
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Liverpool, L22 0LG
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Liverpool, L7 8XP
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London, NW3 2QG
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London, SE1 7EH
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London, W6 8RF
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Manchester, M13 9WL
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Manchester, M15 6SX
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Newcastle upon Tyne, NE1 4LP
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Reading, RG2 0TG
Research Site
Telford, TF1 6TF
Research Site
Wakefield, WF1 4DG
Research Site
West Bromwich, B71 4HJ
Research Site
Whitby, YO21 1SD

Other trials in United Kingdom

Belgium17 sites

Research Site
Anthée, 5520
Research Site
Blankenberge, 8370
Research Site
Brussels, 1080
Research Site
Brussels, 1200
Research Site
Chênée, 4032
Research Site
Ghent, 9000
Research Site
Gozée, 6534
Research Site
Gribomont, 6887
Research Site
Halen, 3545
Research Site
Ham, 3945
Research Site
Hasselt, 3500
Research Site
La Louvière, 7100
Research Site
Linkebeek, 1630
Research Site
Ostend, 8400
Research Site
Tessenderlo, 3980
Research Site
Tremelo, 3120
Research Site
Vilvoorde, 1800

Other trials in Belgium

Czechia16 sites

Research Site
Brno, 602 00
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Brno, 603 00
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Chomutov, 430 02
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Hradec Králové, 500 05
Research Site
Kladno, 272 01
Research Site
Litoměřice, 412 01
Research Site
Moravské Budějovice, 676 02
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Olomouc, 775 20
Research Site
Pardubice, 530 02
Research Site
Pilsen, 305 99
Research Site
Prague, 128 08
Research Site
Prague, 130 00
Research Site
Prague, 140 21
Research Site
Prague, 150 06
Research Site
Slaný, 274 01
Research Site
Svitavy, 568 25

Other trials in Czechia

Australia13 sites

Research Site
Ashford, South Australia, 5035
Research Site
Auchenflower, Queensland, 4066
Research Site
Camperdown, New South Wales, 2015
Research Site
Carina Heights, Queensland, 4152
Research Site
Fullarton, South Australia, 5063
Research Site
Heidelberg Heights, Victoria, 3081
Research Site
Maroubra, New South Wales, 2035
Research Site
Melbourne, Victoria, 3004
Research Site
Perth, Western Australia, 6000
Research Site
Sherwood, Queensland, 4075
Research Site
Sydney, New South Wales, 2010
Research Site
Sydney, New South Wales, 2022
Research Site
Woolloongabba, Queensland, 4102

Other trials in Australia

Germany13 sites

Research Site
Bad Krozingen, 79189
Research Site
Berlin, 10787
Research Site
Berlin, 13353
Research Site
Cologne, 50937
Research Site
Dresden, 01307
Research Site
Hellersdorf, 12627
Research Site
Heppenheim an der Bergstrasse, 64646
Research Site
Homburg, 66421
Research Site
Leipzig, 04103
Research Site
Magdeburg, 39112
Research Site
Messkirch, 88605
Research Site
München, 80638
Research Site
Witten, 58455

Other trials in Germany

Italy12 sites

Research Site
Bologna, 40138
Research Site
Cagliari, 09134
Research Site
Chieti, 66100
Research Site
Cinisello Balsamo (MI), 20092
Research Site
Ferrara, 44124
Research Site
Milan, 20162
Research Site
Naples, 80131
Research Site
Padova, 35128
Research Site
Perugia, 06129
Research Site
Pisa, 56100
Research Site
Pisa, 56124
Research Site
Trieste, 34149

Other trials in Italy

Netherlands12 sites

Research Site
Amsterdam, 1105 AZ
Research Site
Den Helder, 1782 GZ
Research Site
Groningen, 9713 GZ
Research Site
Groningen, 9728 NT
Research Site
Hoogeveen, 7909 AA
Research Site
Hoorn, 1625 HV
Research Site
Nijmegen, 6525 EZ
Research Site
Rotterdam, 3045 PM
Research Site
Tilburg, 5022 GC
Research Site
Utrecht, 3584 CX
Research Site
Waalwijk, 5141 BM
Research Site
Zwijndrecht, 3331 LZ

Other trials in Netherlands

Hungary11 sites

Research Site
Baja, 6500
Research Site
Berettyóújfalu, 4100
Research Site
Budapest, 1085
Research Site
Eger, 3300
Research Site
Gyöngyös, 3200
Research Site
Hódmezővásárhely, 6800
Research Site
Jászberény, 5100
Research Site
Komárom, 2921
Research Site
Mosonmagyaróvár, 9200
Research Site
Pécs, 7624
Research Site
Szeged, 6720

Other trials in Hungary

South Africa10 sites

Research Site
Bloemfontein, 9301
Research Site
Centurion, Gauteng, 0157
Research Site
eManzimtoti, KwaZulu-Natal, 4126
Research Site
Johannesburg, Gauteng, 2193
Research Site
Midrand, Gauteng, 1685
Research Site
Observatory, Western Cape, 7925
Research Site
Paarl, Western Cape, 7646
Research Site
Parow, Western Cape, 7505
Research Site
Somerset West, Western Cape, 7130
Research Site
Sunninghill, Gauteng, 2157

Other trials in South Africa

France9 sites

Research Site
Brest, 29200
Research Site
Bron, 69677
Research Site
Caen, 14033
Research Site
Dijon, 21034
Research Site
Montpellier, 34295
Research Site
Nantes, 44093
Research Site
Paris, 75571
Research Site
Paris, 75651
Research Site
Vénissieux, 69200

Other trials in France

Switzerland9 sites

Research Site
Bellinzona, 6500
Research Site
Geneva, 1211
Research Site
Lausanne, 1011
Research Site
Lugano, 6900
Research Site
Muensterlingen, 8596
Research Site
Reinach, 4153
Research Site
Sankt Gallen, 9007
Research Site
Zurich, 8063
Research Site
Zurich, 8091

Other trials in Switzerland

Spain7 sites

Research Site
Córdoba, Andalusia, 14004
Research Site
L'Hospitalet de Llobregat, Catalonia, 08907
Research Site
Madrid, 28007
Research Site
Madrid, 28029
Research Site
Madrid, 28040
Research Site
Reus, Catalonia, 43204
Research Site
Zaragoza, Aragon, 50009

Other trials in Spain

Sweden7 sites

Research Site
Gothenburg, 413 45
Research Site
Lund, 222 21
Research Site
Örebro, 701 46
Research Site
Stockholm, 111 57
Research Site
Stockholm, 141 86
Research Site
Stockholm, 171 45
Research Site
Uddevalla, 451 50

Other trials in Sweden

Russia6 sites

Research Site
Barnaul, 656055
Research Site
Kemerovo, 650002
Research Site
Moscow, 121552
Research Site
Novosibirsk, 630047
Research Site
Saint Petersburg, 197022
Research Site
Saratov, 410054

Other trials in Russia

Denmark5 sites

Research Site
Aalborg, 9000
Research Site
Aarhus N, 8200
Research Site
Ballerup Municipality, 2750
Research Site
Glostrup Municipality, 2600
Research Site
Vejle, 7100

Other trials in Denmark

Hong Kong2 sites

Research Site
Hong Kong
Research Site
New Territories

Other trials in Hong Kong

Norway2 sites

Research Site
Ålesund, 6003
Research Site
Oslo, 0373

Other trials in Norway

South Korea2 sites

Research Site
Seoul, 120-752
Research Site
Seoul, 135-710

Other trials in South Korea

Taiwan2 sites

Research Site
Kaohsiung City, 83301
Research Site
Taipei, 100

Other trials in Taiwan

Austria1 site

Research Site
Salzburg, 5020

Other trials in Austria

New Zealand1 site

Research Site
Christchurch, 8011

Other trials in New Zealand

Poland1 site

Research Site
Lodz, 91-078

Other trials in Poland

About this study

Official title: A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

Conditions: Hyperlipidemia and Mixed Dyslipidemia
Being tested: Evolocumab, Standard of Care
Keywords: High cholesterol, Raised cholesterol, Cholesterol, Elevated Cholesterol
Medical subject headings: Hyperlipidemias, Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EvolocumabBiological
Also called AMG 145, Repatha
Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
Standard of CareDrug
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

Study groups in NCT01854918
Study group	Role	What they receive
Standard of Care	Active comparator	Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product [all-IP] period. Receives: Biological: Evolocumab; Drug: Standard of Care
Evolocumab + Standard of Care	Experimental	Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice. Receives: Biological: Evolocumab; Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.0, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.
Measured: 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period

Secondary outcomes (2)

Percent Change From Baseline in LDL-C at Weeks 48 and 104
Measured: Baseline of the parent study and weeks 48 amd 104
Change From Baseline in LDL-C at Weeks 48 and 104
Measured: Baseline of the parent study and weeks 48 amd 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Apr 201331 May 2018

First posted16 May 2013 (estimated)
Study start23 Apr 2013
Primary completion31 May 2018
Study completion31 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Hyperlipidemia and Mixed DyslipidemiaStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3,681 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01854918
Sponsor's protocol ID: 20120138
Other IDs: 2012-004357-83
Acronym: OSLER-2
Status last verified: May 2019
First submitted: 1 May 2013
Last updated: 11 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
PubMed 29353350
Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521-1527. doi: 10.1016/j.amjcard.2017.07.047. Epub 2017 Jul 31.
PubMed 28844508
Hovingh GK, Raal FJ, Dent R, Stefanutti C, Descamps O, Masana L, Lira A, Bridges I, Coll B, Sullivan D. Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1448-1457. doi: 10.1016/j.jacl.2017.09.003. Epub 2017 Sep 22.
PubMed 29066265
Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
PubMed 33078867
Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, Ballantyne CM, Somaratne R, Legg J, Wasserman SM, Scott R, Koren MJ, Stein EA; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1500-9. doi: 10.1056/NEJMoa1500858. Epub 2015 Mar 15.
PubMed 25773607

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hyperlipidemia and Mixed Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145
ClinicalTrials.gov ID: NCT01854918
Acronym / sponsor ID: OSLER-2 / 20120138
Conditions: Hyperlipidemia and Mixed Dyslipidemia
Keywords: High cholesterol, Raised cholesterol, Cholesterol, Elevated Cholesterol
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,681 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 23 Apr 2013 (actual)
Primary completion: 31 May 2018 (actual)
Study completion: 31 May 2018 (actual)
First posted: 16 May 2013 (estimated)
Results: Posted 11 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard of Care	Active comparator	Biological: Evolocumab, Drug: Standard of CareParticipants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product [all-IP] period.
Evolocumab + Standard of Care	Experimental	Biological: Evolocumab, Drug: Standard of CareParticipants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114 [NCT01763827], 20110115 [NCT01763866], 20110116 [NCT01763905], 20110117 [NCT01763918], 20110109 [NCT01516879], 20120122 [NCT01953328], 20120332 [NCT01984424], 20120348 [NCT01849497], or 20120356 [NCT01879319]).

Key exclusion criteria (4 listed)

Experienced a treatment-related serious adverse event that led to study drug 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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EvolocumabAlso: AMG 145, RepathaAdministered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen	Biological	Evolocumab + Standard of Care, Standard of Care
Standard of CareStandard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes	Drug	Evolocumab + Standard of Care, Standard of Care

Primary outcome

Number of Participants With Adverse Events
Time frame: 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period
Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.0, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.

2 secondary outcomes

Percent Change From Baseline in LDL-C at Weeks 48 and 104
Time frame: Baseline of the parent study and weeks 48 amd 104
Change From Baseline in LDL-C at Weeks 48 and 104
Time frame: Baseline of the parent study and weeks 48 amd 104

Results and safety

Results posted to the registry on 11 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care	1,227	1,197
Evolocumab + Standard of Care	2,454	2,391

Primary outcome: Number of Participants With Adverse Events

Time frame: 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period. Count of participants. Unit: Participants

Measure	Year 1: Standard of Care n = 1227	Year 1: Evolocumab + Standard of Care n = 2454	Years 2-3: SOC / Evolocumab + SOC n = 1152	Years 2-3: Evolocumab + SOC / Evolocumab + SOC n = 2291
All adverse events	796	1655	929	1789
Adverse events ≥ grade 2	519	1070	700	1339
Adverse events ≥ grade 3	124	225	214	379
Adverse events ≥ grade 4	7	17	11	35
Serious adverse events	104	195	178	332
AEs leading to discontinuation of evolocumab	0	55	26	42
Fatal adverse events	5	5	3	16
Device related adverse events	0	57	25	45

Population analysed: All randomized participants (year 1) and randomized participants on study and who received at least 1 dose of evolocumab in the all-IP period (years 2-3).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Year 1: Standard of Care	104 of 1,227 (8.5%)	334 of 1,227 (27.2%)	5 of 1,227
Year 1: Evolocumab + Standard of Care	195 of 2,454 (7.9%)	681 of 2,454 (27.8%)	5 of 2,454
Years 2-3: SOC / Evolocumab + SOC	181 of 1,197 (15.1%)	498 of 1,197 (41.6%)	5 of 1,197
Years 2-3: Evolocumab + SOC / Evolocumab + SOC	344 of 2,391 (14.4%)	928 of 2,391 (38.8%)	16 of 2,391
Years 2-3: Total	525 of 3,588 (14.6%)	1,426 of 3,588 (39.7%)	21 of 3,588

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29353350Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
Results publication: PubMed 28844508Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521-1527. doi: 10.1016/j.amjcard.2017.07.047. Epub 2017 Jul 31.
Results publication: PubMed 29066265Hovingh GK, Raal FJ, Dent R, Stefanutti C, Descamps O, Masana L, Lira A, Bridges I, Coll B, Sullivan D. Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1448-1457. doi: 10.1016/j.jacl.2017.09.003. Epub 2017 Sep 22.
Derived from this study: PubMed 33078867Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
Derived from this study: PubMed 25773607Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, Ballantyne CM, Somaratne R, Legg J, Wasserman SM, Scott R, Koren MJ, Stein EA; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1500-9. doi: 10.1056/NEJMoa1500858. Epub 2015 Mar 15.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

363 sites in 25 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Evolocumab in people with Hyperlipidemia and Mixed Dyslipidemia, run by Amgen at 363 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 363 sites in United States, Japan, Canada, United Kingdom, Belgium and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01854918, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.