HypercholesterolemiaPhase 2OSLERNCT01439880
Open Label Study of Long Term Evaluation Against LDL-C Trial
A Phase 2 study testing Evolocumab in people with Hypercholesterolemia, run by Amgen at 187 sites in 18 countries.
Trial summary
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- 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
- 1,324 participants
- Where
- 187 sitesin 18 countries
- Study dates
- 7 Oct 2011to 20 Jun 2018
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703)
Who cannot join
- 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)
Trial locations and contacts
187 sites in 18 countries.
187 sites in 18 countries
United States78 sites
Research Site
Akron, Ohio, 44311
Research Site
Anaheim, California, 92801
Research Site
Arlington, Texas, 76018
Research Site
Atlanta, Georgia, 30338
Research Site
Auburn, Maine, 04210
Research Site
Bethesda, Maryland, 20817
Research Site
Birmingham, Alabama, 35216
Research Site
Birmingham, Alabama, 35294
Research Site
Bristol, Tennessee, 37620
Research Site
Brockton, Massachusetts, 02301
Research Site
Brooklyn Center, Minnesota, 55430
Research Site
Cadiz, Ohio, 43907
Research Site
Camp Hill, Pennsylvania, 17011
Research Site
Carmichael, California, 95608
Research Site
Chevy Chase, Maryland, 20815
Research Site
Chicago, Illinois, 60654
Research Site
Cincinnati, Ohio, 45219
Research Site
Cincinnati, Ohio, 45227
Research Site
Cincinnati, Ohio, 45246
Research Site
Cleveland, Ohio, 44122
Research Site
Colorado Springs, Colorado, 80909
Research Site
Cortlandt Manor, New York, 10567
Research Site
Dayton, Ohio, 45414
Research Site
Daytona Beach, Florida, 32117
Research Site
DeLand, Florida, 32720
Research Site
Duncansville, Pennsylvania, 16635
Research Site
Endwell, New York, 13760
Research Site
Fargo, North Dakota, 58103
Research Site
Great Falls, Montana, 59405
Research Site
Green Cove Springs, Florida, 32043
Research Site
Henderson, Nevada, 89052
Research Site
Houston, Texas, 77002
Research Site
Houston, Texas, 77074
Research Site
Indianapolis, Indiana, 46260
Research Site
Inglewood, California, 90301
Research Site
Iowa City, Iowa, 52242
Research Site
Jacksonville, Florida, 32216
Research Site
Jacksonville, Florida, 32223
Research Site
Las Vegas, Nevada, 89117
Research Site
Las Vegas, Nevada, 89148
Research Site
Little Rock, Arkansas, 72205
Research Site
Littleton, Colorado, 80120
Research Site
Louisville, Kentucky, 40213
Research Site
Malvern, Arkansas, 72104
Research Site
Marquette, Michigan, 49855
Research Site
Melbourne, Florida, 32901
Research Site
Miami, Florida, 33144
Research Site
Miami, Florida, 33173
Research Site
Mission Viejo, California, 92691
Research Site
Mt. Pleasant, South Carolina, 29464
Research Site
Munster, Indiana, 46321
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
Pittsburgh, Pennsylvania, 15216
Research Site
Ponte Vedra, Florida, 32081
Research Site
Port Charlotte, Florida, 33952
Research Site
Portland, Maine, 04101
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
San Antonio, Texas, 78229
Research Site
Sanford, Florida, 32771
Research Site
Savannah, Georgia, 31406
Research Site
Seattle, Washington, 98122
Research Site
Tacoma, Washington, 98405
Research Site
Thousand Oaks, California, 91360
Research Site
Tucson, Arizona, 85710
Research Site
Tupelo, Mississippi, 38801
Research Site
Tustin, California, 92780
Research Site
Williamsville, New York, 14221
Research Site
Winston-Salem, North Carolina, 27103
Research Site
York, Pennsylvania, 17405
Japan32 sites
Research Site
Chiyoda-ku, Tokyo, 101-0041
Research Site
Fujioka-shi, Gunma, 375-0015
Research Site
Fukui-shi, Fukui, 910-0837
Research Site
Hachioji-shi, Tokyo, 192-0918
Research Site
Hanyu-shi, Saitama, 348-8505
Research Site
Hitachi-shi, Ibaraki, 317-0077
Research Site
Ibaraki-shi, Osaka, 567-0876
Research Site
Ina-shi, Nagano, 396-8555
Research Site
Itabashi-ku, Tokyo, 173-8610
Research Site
Kasuga-shi, Fukuoka, 816-0864
Research Site
Kawanishi-shi, Hyōgo, 666-0125
Research Site
Kobe, Hyōgo, 657-0068
Research Site
Kochi, Kochi, 781-8555
Research Site
Koga-shi, Ibaraki, 306-0041
Research Site
Komatsu-shi, Ishikawa-ken, 923-8560
Research Site
Kyoto, Kyoto, 613-0911
Research Site
Kyoto, Kyoto, 615-8125
Research Site
Maebashi, Gunma, 371-0022
Research Site
Maebashi, Gunma, 371-0046
Research Site
Matsumoto-shi, Nagano, 390-0848
Research Site
Mito, Ibaraki, 311-4198
Research Site
Nagoya, Aichi-ken, 454-0933
Research Site
Nagoya, Aichi-ken, 455-8530
Research Site
Nagoya, Aichi-ken, 462-0825
Research Site
Sayama-shi, Saitama, 350-1305
Research Site
Shinagawa-ku, Tokyo, 141-0001
Research Site
Suwa-shi, Nagano, 392-8510
Research Site
Takamatsu, Kagawa-ken, 760-8557
Research Site
Takasaki-shi, Gunma, 370-0829
Research Site
Toda-shi, Saitama, 335-0023
Research Site
Toshima-ku, Tokyo, 171-0021
Research Site
Toyonaka-shi, Osaka, 560-0082
Canada20 sites
Research Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0
Research Site
Cambridge, Ontario, N1R 6V6
Research Site
Chicoutimi, Quebec, G7H 5H6
Research Site
Gatineau, Quebec, J8Y 6S9
Research Site
Granby, Quebec, J2G 8Z9
Research Site
Greater Sudbury, Ontario, P3C 5K7
Research Site
Kelowna, British Columbia, V1Y 1V6
Research Site
Lachine, Quebec, H8S 2E4
Research Site
London, Ontario, N5W 6A2
Research Site
London, Ontario, N6A 5B7
Research Site
Mount Pearl, Newfoundland and Labrador, A1N 1W7
Research Site
Newmarket, Ontario, L3Y 5G8
Research Site
Pointe-Claire, Quebec, H9R 3J1
Research Site
Québec, Quebec, G1V 4M6
Research Site
Sarnia, Ontario, N7T 4X3
Research Site
St. John's, Newfoundland and Labrador, A1A 3R5
Research Site
Toronto, Ontario, M8V 3X8
Research Site
Toronto, Ontario, M9V 4B4
Research Site
Toronto, Ontario, M9W 4L6
Research Site
Woodstock, Ontario, N4S 5P5
Czechia10 sites
Research Site
Brno, 601 77
Research Site
Brno, 603 00
Research Site
Brno, 625 00
Research Site
Olomouc, 775 20
Research Site
Prague, 120 00
Research Site
Prague, 140 21
Research Site
Slaný, 274 01
Research Site
Svitavy, 568 25
Research Site
Ústí nad Orlicí, 562 18
Research Site
Znojmo, 669 02
Belgium8 sites
Research Site
Anthée, 5520
Research Site
Brussels, 1200
Research Site
Gozée, 6534
Research Site
Gribomont, 6887
Research Site
Halen, 3545
Research Site
Ham, 3945
Research Site
Linkebeek, 1630
Research Site
Uccle, 1180
Hungary8 sites
Research Site
Budapest, 1096
Research Site
Debrecen, 4032
Research Site
Dunaújváros, 2400
Research Site
Gyula, 5700
Research Site
Kecskemét, 6000
Research Site
Komárom, 2921
Research Site
Szolnok, 5004
Research Site
Zalaegerszeg, 8900
Spain5 sites
Research Site
Barcelona, Catalonia, 08036
Research Site
Córdoba, Andalusia, 14004
Research Site
Madrid, 28040
Research Site
Reus, Catalonia, 43204
Research Site
Zaragoza, Aragon, 50009
Australia4 sites
Research Site
Camperdown, New South Wales, 2015
Research Site
Maroubra, New South Wales, 2035
Research Site
Perth, Western Australia, 6000
Research Site
Sydney, New South Wales, 2022
South Africa4 sites
Research Site
Johannesburg, Gauteng, 2193
Research Site
Midrand, Gauteng, 1685
Research Site
Observatory, Western Cape, 7925
Research Site
Parow, Western Cape, 7505
Sweden4 sites
Research Site
Gothenburg, 412 63
Research Site
Lund, 222 21
Research Site
Stockholm, 111 35
Research Site
Stockholm, 141 86
Denmark3 sites
Research Site
Aalborg, 9000
Research Site
Ballerup Municipality, 2750
Research Site
Vejle, 7100
Netherlands3 sites
Research Site
Amsterdam, 1105 AZ
Research Site
Hoorn, 1625 HV
Research Site
Utrecht, 3584 CX
About this study
Official title: A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145 (Evolocumab)
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.
- Conditions
- Hypercholesterolemia
- Being tested
- Evolocumab, Standard of care
- Keywords
- High cholesterol, Raised cholesterol, Cholesterol, Elevated Cholesterol
- Medical subject headings
- 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
Standard of careOther
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
| 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 52 participants began treatment with evolocumab 420 mg once a month (QM) for 4 years during the all-investigational product [all-IP] period. Receives: Biological: Evolocumab; Other: Standard of care |
| Evolocumab + SOC | Experimental | 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. Receives: Biological: Evolocumab |
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 4.03, 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.
Measured: 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
Measured: 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
Measured: Baseline of parent study and extension study weeks 24 and 52
Apolipoprotein B Level at Week 24 and Week 52
Measured: Baseline of parent study and extension study weeks 24 and 52
Total Cholesterol/HDL-C Ratio at Week 24 and Week 52
Measured: Baseline of parent study and extension study weeks 24 and 52
Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52
Measured: Baseline of parent study and extension study weeks 24 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study start7 Oct 2011
- Primary completion20 Jun 2018
- Study completion20 Jun 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 (11)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439880
- Sponsor's protocol ID
- 20110110
- Other IDs
- 2011-001915-29
- Acronym
- OSLER
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2011
- Last updated
- 21 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28291870Koren 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.
PubMed 24255061Daviglus 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.
PubMed 33325247Hovingh 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 29066265Koren 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.
PubMed 31648705Kasichayanula 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 29353350Sattar 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 28844508Toth 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.
PubMed 32114889Schludi 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.
PubMed 35760720Hirayama 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.
PubMed 30930429Sabatine 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. 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 (Evolocumab)
- ClinicalTrials.gov ID
- NCT01439880
- Acronym / sponsor ID
- OSLER / 20110110
- Conditions
- Hypercholesterolemia
- Keywords
- High cholesterol, Raised cholesterol, Cholesterol, Elevated Cholesterol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,324 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2011 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Posted 10 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.
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, Other: Standard of careParticipants 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 | Experimental | Biological: EvolocumabParticipants 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. |
Who may qualify
- Ages
- 18 to 75 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 protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703)
Key exclusion criteria (4 listed)
- 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)
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 | Biological | Evolocumab + SOC, Standard of Care |
| Standard of careStandard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes | Other | Standard of Care |
Primary outcome
Number of Participants With Adverse Events
Time frame: 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.
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.
5 secondary outcomes
Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52
Time frame: 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
Time frame: Baseline of parent study and extension study weeks 24 and 52
Apolipoprotein B Level at Week 24 and Week 52
Time frame: Baseline of parent study and extension study weeks 24 and 52
Total Cholesterol/HDL-C Ratio at Week 24 and Week 52
Time frame: Baseline of parent study and extension study weeks 24 and 52
Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52
Time frame: Baseline of parent study and extension study weeks 24 and 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28291870Koren 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.
- Background: PubMed 24255061Koren 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.
- Background: PubMed 33325247Daviglus 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.
- Background: 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.
- Background: PubMed 31648705Koren 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.
- 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.
- Background: 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.
- Background: PubMed 32114889Toth 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.
- Background: PubMed 35760720Schludi 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.
- Background: PubMed 30930429Hirayama 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.
- 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
187 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Evolocumab in people with Hypercholesterolemia, run by Amgen at 187 sites in 18 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 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 187 sites in United States, Japan, Canada, Czechia, Belgium and 13 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 10 Jul 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: 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.). 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 NCT01439880, which also lists 11 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 21 Sep 2022.