Open Label Study of Long Term Evaluation Against LDL-C Trial
OSLER
A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145 (Evolocumab)
2 other identifiers
interventional
1,324
18 countries
187
Brief Summary
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2011
Longer than P75 for phase_2
187 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2011
CompletedFirst Posted
Study publicly available on registry
September 23, 2011
CompletedStudy Start
First participant enrolled
October 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2018
CompletedResults Posted
Study results publicly available
July 10, 2019
CompletedSeptember 21, 2022
September 1, 2022
6.7 years
September 22, 2011
June 17, 2019
September 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 4.03, 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.
52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.
Secondary Outcomes (5)
Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52
Baseline of parent study and extension study weeks 24 and 52
Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52
Baseline of parent study and extension study weeks 24 and 52
Apolipoprotein B Level at Week 24 and Week 52
Baseline of parent study and extension study weeks 24 and 52
Total Cholesterol/HDL-C Ratio at Week 24 and Week 52
Baseline of parent study and extension study weeks 24 and 52
Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52
Baseline of parent study and extension study weeks 24 and 52
Study Arms (2)
Standard of Care
ACTIVE COMPARATORParticipants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 52 participants began treatment with evolocumab 420 mg once a month (QM) for 4 years during the all-investigational product \[all-IP\] period.
Evolocumab + SOC
EXPERIMENTALParticipants received evolocumab 420 mg once a month plus standard of care for the first year of the study (SOC-controlled period). At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.
Interventions
Administered by subcutaneous injection
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Eligibility Criteria
You may qualify if:
- Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703)
You may not qualify if:
- Experienced a treatment-related serious adverse event that led to investigational product (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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (187)
Research Site
Birmingham, Alabama, 35216, United States
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Birmingham, Alabama, 35294, United States
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Tucson, Arizona, 85710, United States
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Little Rock, Arkansas, 72205, United States
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Malvern, Arkansas, 72104, United States
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Anaheim, California, 92801, United States
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Carmichael, California, 95608, United States
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Inglewood, California, 90301, United States
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Mission Viejo, California, 92691, United States
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Newport Beach, California, 92663, United States
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Thousand Oaks, California, 91360, United States
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Tustin, California, 92780, United States
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Colorado Springs, Colorado, 80909, United States
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Littleton, Colorado, 80120, United States
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Daytona Beach, Florida, 32117, United States
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DeLand, Florida, 32720, United States
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Green Cove Springs, Florida, 32043, United States
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Jacksonville, Florida, 32216, United States
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Jacksonville, Florida, 32223, United States
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Melbourne, Florida, 32901, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33173, United States
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Ponte Vedra, Florida, 32081, United States
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Port Charlotte, Florida, 33952, United States
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Sanford, Florida, 32771, United States
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Atlanta, Georgia, 30338, United States
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Savannah, Georgia, 31406, United States
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Chicago, Illinois, 60654, United States
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Indianapolis, Indiana, 46260, United States
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Munster, Indiana, 46321, United States
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Iowa City, Iowa, 52242, United States
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Louisville, Kentucky, 40213, United States
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Auburn, Maine, 04210, United States
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Portland, Maine, 04101, United States
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Bethesda, Maryland, 20817, United States
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Chevy Chase, Maryland, 20815, United States
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Brockton, Massachusetts, 02301, United States
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Marquette, Michigan, 49855, United States
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Brooklyn Center, Minnesota, 55430, United States
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Tupelo, Mississippi, 38801, United States
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Great Falls, Montana, 59405, United States
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Henderson, Nevada, 89052, United States
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Las Vegas, Nevada, 89117, United States
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Las Vegas, Nevada, 89148, United States
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Cortlandt Manor, New York, 10567, United States
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Endwell, New York, 13760, United States
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New York, New York, 10029, United States
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Williamsville, New York, 14221, United States
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Raleigh, North Carolina, 27609, United States
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Raleigh, North Carolina, 27612, United States
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Winston-Salem, North Carolina, 27103, United States
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Fargo, North Dakota, 58103, United States
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Akron, Ohio, 44311, United States
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Cadiz, Ohio, 43907, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45227, United States
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Cincinnati, Ohio, 45246, United States
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Cleveland, Ohio, 44122, United States
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Dayton, Ohio, 45414, United States
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Norman, Oklahoma, 73069, United States
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Oklahoma City, Oklahoma, 73103, United States
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Camp Hill, Pennsylvania, 17011, United States
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Duncansville, Pennsylvania, 16635, United States
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Pittsburgh, Pennsylvania, 15216, United States
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York, Pennsylvania, 17405, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Rapid City, South Dakota, 57701, United States
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Rapid City, South Dakota, 57702, United States
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Bristol, Tennessee, 37620, United States
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Arlington, Texas, 76018, United States
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Houston, Texas, 77002, United States
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Houston, Texas, 77074, United States
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San Antonio, Texas, 78229, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23294, United States
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Renton, Washington, 98057, United States
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Seattle, Washington, 98122, United States
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Tacoma, Washington, 98405, United States
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Camperdown, New South Wales, 2015, Australia
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Maroubra, New South Wales, 2035, Australia
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Sydney, New South Wales, 2022, Australia
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Perth, Western Australia, 6000, Australia
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Anthée, 5520, Belgium
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Brussels, 1200, Belgium
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Gozée, 6534, Belgium
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Gribomont, 6887, Belgium
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Halen, 3545, Belgium
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Ham, 3945, Belgium
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Linkebeek, 1630, Belgium
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Uccle, 1180, Belgium
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Kelowna, British Columbia, V1Y 1V6, Canada
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Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada
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Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada
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St. John's, Newfoundland and Labrador, A1A 3R5, Canada
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Cambridge, Ontario, N1R 6V6, Canada
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Greater Sudbury, Ontario, P3C 5K7, Canada
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London, Ontario, N5W 6A2, Canada
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London, Ontario, N6A 5B7, Canada
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Newmarket, Ontario, L3Y 5G8, Canada
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Sarnia, Ontario, N7T 4X3, Canada
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Toronto, Ontario, M8V 3X8, Canada
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Toronto, Ontario, M9V 4B4, Canada
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Toronto, Ontario, M9W 4L6, Canada
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Woodstock, Ontario, N4S 5P5, Canada
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Chicoutimi, Quebec, G7H 5H6, Canada
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Gatineau, Quebec, J8Y 6S9, Canada
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Granby, Quebec, J2G 8Z9, Canada
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Lachine, Quebec, H8S 2E4, Canada
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Pointe-Claire, Quebec, H9R 3J1, Canada
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Québec, Quebec, G1V 4M6, Canada
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Brno, 601 77, Czechia
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Brno, 603 00, Czechia
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Brno, 625 00, Czechia
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Olomouc, 775 20, Czechia
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Prague, 120 00, Czechia
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Prague, 140 21, Czechia
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Slaný, 274 01, Czechia
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Svitavy, 568 25, Czechia
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Ústí nad Orlicí, 562 18, Czechia
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Znojmo, 669 02, Czechia
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Aalborg, 9000, Denmark
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Ballerup Municipality, 2750, Denmark
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Vejle, 7100, Denmark
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Helsinki, 00290, Finland
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OYS, 90029, Finland
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Berlin, 13353, Germany
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Cologne, 50937, Germany
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New Territories, Hong Kong
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Budapest, 1096, Hungary
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Debrecen, 4032, Hungary
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Dunaújváros, 2400, Hungary
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Gyula, 5700, Hungary
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Kecskemét, 6000, Hungary
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Komárom, 2921, Hungary
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Szolnok, 5004, Hungary
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Zalaegerszeg, 8900, Hungary
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Nagoya, Aichi-ken, 454-0933, Japan
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Nagoya, Aichi-ken, 455-8530, Japan
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Nagoya, Aichi-ken, 462-0825, Japan
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Fukui-shi, Fukui, 910-0837, Japan
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Kasuga-shi, Fukuoka, 816-0864, Japan
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Fujioka-shi, Gunma, 375-0015, Japan
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Maebashi, Gunma, 371-0022, Japan
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Maebashi, Gunma, 371-0046, Japan
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Takasaki-shi, Gunma, 370-0829, Japan
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Kawanishi-shi, Hyōgo, 666-0125, Japan
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Kobe, Hyōgo, 657-0068, Japan
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Hitachi-shi, Ibaraki, 317-0077, Japan
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Koga-shi, Ibaraki, 306-0041, Japan
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Mito, Ibaraki, 311-4198, Japan
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Komatsu-shi, Ishikawa-ken, 923-8560, Japan
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Takamatsu, Kagawa-ken, 760-8557, Japan
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Kochi, Kochi, 781-8555, Japan
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Kyoto, Kyoto, 613-0911, Japan
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Kyoto, Kyoto, 615-8125, Japan
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Ina-shi, Nagano, 396-8555, Japan
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Matsumoto-shi, Nagano, 390-0848, Japan
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Suwa-shi, Nagano, 392-8510, Japan
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Ibaraki-shi, Osaka, 567-0876, Japan
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Toyonaka-shi, Osaka, 560-0082, Japan
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Hanyu-shi, Saitama, 348-8505, Japan
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Sayama-shi, Saitama, 350-1305, Japan
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Toda-shi, Saitama, 335-0023, Japan
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Chiyoda-ku, Tokyo, 101-0041, Japan
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Hachioji-shi, Tokyo, 192-0918, Japan
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Itabashi-ku, Tokyo, 173-8610, Japan
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Shinagawa-ku, Tokyo, 141-0001, Japan
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Toshima-ku, Tokyo, 171-0021, Japan
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Amsterdam, 1105 AZ, Netherlands
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Hoorn, 1625 HV, Netherlands
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Utrecht, 3584 CX, Netherlands
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Oslo, 0373, Norway
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Singapore, 169609, Singapore
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Johannesburg, Gauteng, 2193, South Africa
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Midrand, Gauteng, 1685, South Africa
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Observatory, Western Cape, 7925, South Africa
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Parow, Western Cape, 7505, South Africa
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Córdoba, Andalusia, 14004, Spain
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Zaragoza, Aragon, 50009, Spain
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Barcelona, Catalonia, 08036, Spain
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Reus, Catalonia, 43204, Spain
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Madrid, 28040, Spain
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Gothenburg, 412 63, Sweden
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Lund, 222 21, Sweden
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Stockholm, 111 35, Sweden
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Stockholm, 141 86, Sweden
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London, SW10 9NH, United Kingdom
Related Publications (11)
Koren MJ, Sabatine MS, Giugliano RP, Langslet G, Wiviott SD, Kassahun H, Ruzza A, Ma Y, Somaratne R, Raal FJ. Long-term Low-Density Lipoprotein Cholesterol-Lowering Efficacy, Persistence, and Safety of Evolocumab in Treatment of Hypercholesterolemia: Results Up to 4 Years From the Open-Label OSLER-1 Extension Study. JAMA Cardiol. 2017 Jun 1;2(6):598-607. doi: 10.1001/jamacardio.2017.0747.
PMID: 28291870BACKGROUNDKoren MJ, Giugliano RP, Raal FJ, Sullivan D, Bolognese M, Langslet G, Civeira F, Somaratne R, Nelson P, Liu T, Scott R, Wasserman SM, Sabatine MS; OSLER Investigators. Efficacy and safety of longer-term administration of evolocumab (AMG 145) in patients with hypercholesterolemia: 52-week results from the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER) randomized trial. Circulation. 2014 Jan 14;129(2):234-43. doi: 10.1161/CIRCULATIONAHA.113.007012. Epub 2013 Nov 19.
PMID: 24255061BACKGROUNDDaviglus ML, Ferdinand KC, Lopez JAG, Wu Y, Monsalvo ML, Rodriguez CJ. Effects of Evolocumab on Low-Density Lipoprotein Cholesterol, Non-High Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a) by Race and Ethnicity: A Meta-Analysis of Individual Participant Data From Double-Blind and Open-Label Extension Studies. J Am Heart Assoc. 2021 Jan 5;10(1):e016839. doi: 10.1161/JAHA.120.016839. Epub 2020 Dec 16.
PMID: 33325247BACKGROUNDHovingh 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.
PMID: 29066265BACKGROUNDKoren MJ, Sabatine MS, Giugliano RP, Langslet G, Wiviott SD, Ruzza A, Ma Y, Hamer AW, Wasserman SM, Raal FJ. Long-Term Efficacy and Safety of Evolocumab in Patients With Hypercholesterolemia. J Am Coll Cardiol. 2019 Oct 29;74(17):2132-2146. doi: 10.1016/j.jacc.2019.08.1024.
PMID: 31648705BACKGROUNDKasichayanula 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.
PMID: 29353350BACKGROUNDSattar 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.
PMID: 28844508BACKGROUNDToth PP, Jones SR, Monsalvo ML, Elliott-Davey M, Lopez JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2.
PMID: 32114889BACKGROUNDSchludi B, Giugliano RP, Sabatine MS, Raal FJ, Teramoto T, Koren MJ, Stein EA, Wang H, Monsalvo ML. Time-averaged low-density lipoprotein cholesterol lowering with evolocumab: Pooled analysis of phase 2 trials. J Clin Lipidol. 2022 Jul-Aug;16(4):538-543. doi: 10.1016/j.jacl.2022.05.069. Epub 2022 Jun 6.
PMID: 35760720BACKGROUNDHirayama A, Yamashita S, Ruzza A, Inomata H, Cyrille M, Lu C, Hamer AW, Yoshida M, Kiyosue A, Teramoto T. Long-Term Treatment With Evolocumab Among Japanese Patients - Final Report of the OSLER Open-Label Extension Studies. Circ J. 2019 Apr 25;83(5):971-977. doi: 10.1253/circj.CJ-19-0139. Epub 2019 Mar 29.
PMID: 30930429BACKGROUNDSabatine 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.
PMID: 25773607DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2011
First Posted
September 23, 2011
Study Start
October 7, 2011
Primary Completion
June 20, 2018
Study Completion
June 20, 2018
Last Updated
September 21, 2022
Results First Posted
July 10, 2019
Record last verified: 2022-09