Open Label Study of Long Term Evaluation Against LDL-C Trial
NCT ID: NCT01439880
Last Updated: 2022-09-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
1324 participants
INTERVENTIONAL
2011-10-07
2018-06-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
NCT01854918
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
NCT02304484
Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders
NCT01624142
Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults With Hyperlipidemia on Stable Doses of a Statin
NCT01133522
LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
NCT01763866
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard of Care
Participants 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
Administered by subcutaneous injection
Standard of care
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Evolocumab + SOC
Participants 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.
Evolocumab
Administered by subcutaneous injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Evolocumab
Administered by subcutaneous injection
Standard of care
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Birmingham, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Tucson, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Malvern, Arkansas, United States
Research Site
Anaheim, California, United States
Research Site
Carmichael, California, United States
Research Site
Inglewood, California, United States
Research Site
Mission Viejo, California, United States
Research Site
Newport Beach, California, United States
Research Site
Thousand Oaks, California, United States
Research Site
Tustin, California, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Littleton, Colorado, United States
Research Site
Daytona Beach, Florida, United States
Research Site
DeLand, Florida, United States
Research Site
Green Cove Springs, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Melbourne, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Ponte Vedra, Florida, United States
Research Site
Port Charlotte, Florida, United States
Research Site
Sanford, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Savannah, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Munster, Indiana, United States
Research Site
Iowa City, Iowa, United States
Research Site
Louisville, Kentucky, United States
Research Site
Auburn, Maine, United States
Research Site
Portland, Maine, United States
Research Site
Bethesda, Maryland, United States
Research Site
Chevy Chase, Maryland, United States
Research Site
Brockton, Massachusetts, United States
Research Site
Marquette, Michigan, United States
Research Site
Brooklyn Center, Minnesota, United States
Research Site
Tupelo, Mississippi, United States
Research Site
Great Falls, Montana, United States
Research Site
Henderson, Nevada, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Cortlandt Manor, New York, United States
Research Site
Endwell, New York, United States
Research Site
New York, New York, United States
Research Site
Williamsville, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Fargo, North Dakota, United States
Research Site
Akron, Ohio, United States
Research Site
Cadiz, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Norman, Oklahoma, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Camp Hill, Pennsylvania, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
York, Pennsylvania, United States
Research Site
Mt. Pleasant, South Carolina, United States
Research Site
Rapid City, South Dakota, United States
Research Site
Rapid City, South Dakota, United States
Research Site
Bristol, Tennessee, United States
Research Site
Arlington, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Norfolk, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Renton, Washington, United States
Research Site
Seattle, Washington, United States
Research Site
Tacoma, Washington, United States
Research Site
Camperdown, New South Wales, Australia
Research Site
Maroubra, New South Wales, Australia
Research Site
Sydney, New South Wales, Australia
Research Site
Perth, Western Australia, Australia
Research Site
Anthée, , Belgium
Research Site
Brussels, , Belgium
Research Site
Gozée, , Belgium
Research Site
Gribomont, , Belgium
Research Site
Halen, , Belgium
Research Site
Ham, , Belgium
Research Site
Linkebeek, , Belgium
Research Site
Uccle, , Belgium
Research Site
Kelowna, British Columbia, Canada
Research Site
Bay Roberts, Newfoundland and Labrador, Canada
Research Site
Mount Pearl, Newfoundland and Labrador, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Cambridge, Ontario, Canada
Research Site
Greater Sudbury, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Newmarket, Ontario, Canada
Research Site
Sarnia, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Woodstock, Ontario, Canada
Research Site
Chicoutimi, Quebec, Canada
Research Site
Gatineau, Quebec, Canada
Research Site
Granby, Quebec, Canada
Research Site
Lachine, Quebec, Canada
Research Site
Pointe-Claire, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Brno, , Czechia
Research Site
Brno, , Czechia
Research Site
Brno, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Slaný, , Czechia
Research Site
Svitavy, , Czechia
Research Site
Ústí nad Orlicí, , Czechia
Research Site
Znojmo, , Czechia
Research Site
Aalborg, , Denmark
Research Site
Ballerup Municipality, , Denmark
Research Site
Vejle, , Denmark
Research Site
Helsinki, , Finland
Research Site
OYS, , Finland
Research Site
Berlin, , Germany
Research Site
Cologne, , Germany
Research Site
New Territories, , Hong Kong
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Dunaújváros, , Hungary
Research Site
Gyula, , Hungary
Research Site
Kecskemét, , Hungary
Research Site
Komárom, , Hungary
Research Site
Szolnok, , Hungary
Research Site
Zalaegerszeg, , Hungary
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Fukui-shi, Fukui, Japan
Research Site
Kasuga-shi, Fukuoka, Japan
Research Site
Fujioka-shi, Gunma, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Takasaki-shi, Gunma, Japan
Research Site
Kawanishi-shi, Hyōgo, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Hitachi-shi, Ibaraki, Japan
Research Site
Koga-shi, Ibaraki, Japan
Research Site
Mito, Ibaraki, Japan
Research Site
Komatsu-shi, Ishikawa-ken, Japan
Research Site
Takamatsu, Kagawa-ken, Japan
Research Site
Kochi, Kochi, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Ina-shi, Nagano, Japan
Research Site
Matsumoto-shi, Nagano, Japan
Research Site
Suwa-shi, Nagano, Japan
Research Site
Ibaraki-shi, Osaka, Japan
Research Site
Toyonaka-shi, Osaka, Japan
Research Site
Hanyu-shi, Saitama, Japan
Research Site
Sayama-shi, Saitama, Japan
Research Site
Toda-shi, Saitama, Japan
Research Site
Chiyoda-ku, Tokyo, Japan
Research Site
Hachioji-shi, Tokyo, Japan
Research Site
Itabashi-ku, Tokyo, Japan
Research Site
Shinagawa-ku, Tokyo, Japan
Research Site
Toshima-ku, Tokyo, Japan
Research Site
Amsterdam, , Netherlands
Research Site
Hoorn, , Netherlands
Research Site
Utrecht, , Netherlands
Research Site
Oslo, , Norway
Research Site
Singapore, , Singapore
Research Site
Johannesburg, Gauteng, South Africa
Research Site
Midrand, Gauteng, South Africa
Research Site
Observatory, Western Cape, South Africa
Research Site
Parow, Western Cape, South Africa
Research Site
Córdoba, Andalusia, Spain
Research Site
Zaragoza, Aragon, Spain
Research Site
Barcelona, Catalonia, Spain
Research Site
Reus, Catalonia, Spain
Research Site
Madrid, , Spain
Research Site
Gothenburg, , Sweden
Research Site
Lund, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Stockholm, , Sweden
Research Site
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Koren 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.
Daviglus 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.
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.
Koren 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.
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.
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.
Toth 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.
Schludi 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.
Hirayama 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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-001915-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20110110
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.