NCT01439880 (OSLER) is a Phase 2 clinical trial of Evolocumab in Hypercholesterolemia, sponsored by Amgen.

Who is sponsoring NCT01439880?

NCT01439880 is sponsored by Amgen.

What drugs are being tested in NCT01439880?

Interventions in NCT01439880: Evolocumab, Standard of care.

What condition does NCT01439880 study?

NCT01439880 studies Hypercholesterolemia.

Is NCT01439880 still recruiting?

NCT01439880 is currently completed. Last updated 21 September 2022.

Are results published for NCT01439880?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-09-21 · How we verify

NCT01439880: OSLER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Open Label Study of Long Term Evaluation Against LDL-C Trial

Completed Phase 2 Results posted Last updated 21 September 2022

What this trial tests

Phase 2 trial testing Evolocumab in Hypercholesterolemia in 1,324 participants. Completed in 20 June 2018.

Timeline

7 October 2011

Primary endpoint
20 June 2018

20 June 2018

Quick facts

Lead sponsor	Amgen
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,324
Start date	7 October 2011
Primary completion	20 June 2018
Estimated completion	20 June 2018
Sites	187 locations across Denmark, Hong Kong, Finland, Japan, Netherlands, South Africa, Belgium, Sweden

Drugs / interventions tested

Evolocumab (EVOLOCUMAB) — full drug profile →
Standard of care

Conditions studied

Hypercholesterolemia — all drugs for Hypercholesterolemia →

Sponsor

Amgen — full company profile →

Who can join

Adults 18 to 75, any sex, with Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events Primary · 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.

All adverse events

Group	Value	95% CI
SOC-controlled Period: Standard of Care	327
SOC-controlled Period: Evolocumab + SOC	728
All-IP Period: SOC / Evolocumab + SOC	342
All-IP Period: Evolocumab + SOC / Evolocumab + SOC	718

Adverse events ≥ grade 3

Group	Value	95% CI
SOC-controlled Period: Standard of Care	46
SOC-controlled Period: Evolocumab + SOC	99
All-IP Period: SOC / Evolocumab + SOC	111
All-IP Period: Evolocumab + SOC / Evolocumab + SOC	229

Adverse events ≥ grade 4

Group	Value	95% CI
SOC-controlled Period: Standard of Care	2
SOC-controlled Period: Evolocumab + SOC	11
All-IP Period: SOC / Evolocumab + SOC	8
All-IP Period: Evolocumab + SOC / Evolocumab + SOC	28

Serious adverse events

Group	Value	95% CI
SOC-controlled Period: Standard of Care	30
SOC-controlled Period: Evolocumab + SOC	72
All-IP Period: SOC / Evolocumab + SOC	76
All-IP Period: Evolocumab + SOC / Evolocumab + SOC	172

AEs leading to discontinuation of evolocumab

Group	Value	95% CI
SOC-controlled Period: Standard of Care	0
SOC-controlled Period: Evolocumab + SOC	28
All-IP Period: SOC / Evolocumab + SOC	16
All-IP Period: Evolocumab + SOC / Evolocumab + SOC	27

Fatal adverse events

Group	Value	95% CI
SOC-controlled Period: Standard of Care	0
SOC-controlled Period: Evolocumab + SOC	0
All-IP Period: SOC / Evolocumab + SOC	1
All-IP Period: Evolocumab + SOC / Evolocumab + SOC	3

Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 Secondary · Baseline of parent study and extension study weeks 24 and 52

Parent Study Baseline

Group	Value	95% CI
Standard of Care	144.6	± 37.4
Evolocumab + SOC	139.7	± 36.7
Control in Parent Study: SOC	147.7	± 34.3
Control in Parent Study: Evolocumab + SOC	139.5	± 33.6
Evolocumab in Parent Study: SOC	143.4	± 38.5
Evolocumab in Parent Study: Evolocumab + SOC	139.8	± 37.8

Week 24

Group	Value	95% CI
Standard of Care	136.9	± 41.5
Evolocumab + SOC	64.1	± 33.3
Control in Parent Study: SOC	142.5	± 44.7
Control in Parent Study: Evolocumab + SOC	63.9	± 34.6
Evolocumab in Parent Study: SOC	134.8	± 40.2
Evolocumab in Parent Study: Evolocumab + SOC	64.2	± 32.9

Week 52

Group	Value	95% CI
Standard of Care	140.5	± 40.0
Evolocumab + SOC	65.0	± 34.4
Control in Parent Study: SOC	143.1	± 39.8
Control in Parent Study: Evolocumab + SOC	64.1	± 33.2
Evolocumab in Parent Study: SOC	139.4	± 40.1
Evolocumab in Parent Study: Evolocumab + SOC	65.3	± 34.9

Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 Secondary · Baseline of parent study and extension study weeks 24 and 52

Parent Study Baseline

Group	Value	95% CI
Standard of Care	170.7	± 43.0
Evolocumab + SOC	165.1	± 40.9
Control in Parent Study: SOC	173.8	± 39.6
Control in Parent Study: Evolocumab + SOC	165.5	± 38.9
Evolocumab in Parent Study: SOC	169.6	± 44.2
Evolocumab in Parent Study: Evolocumab + SOC	165.0	± 41.7

Week 24

Group	Value	95% CI
Standard of Care	161.4	± 45.5
Evolocumab + SOC	84.3	± 37.7
Control in Parent Study: SOC	166.9	± 47.5
Control in Parent Study: Evolocumab + SOC	84.3	± 39.0
Evolocumab in Parent Study: SOC	159.4	± 44.6
Evolocumab in Parent Study: Evolocumab + SOC	84.3	± 37.3

Week 52

Group	Value	95% CI
Standard of Care	164.9	± 44.5
Evolocumab + SOC	85.3	± 39.0
Control in Parent Study: SOC	168.8	± 45.3
Control in Parent Study: Evolocumab + SOC	85.0	± 38.4
Evolocumab in Parent Study: SOC	163.4	± 44.1
Evolocumab in Parent Study: Evolocumab + SOC	85.4	± 39.2

Apolipoprotein B Level at Week 24 and Week 52 Secondary · Baseline of parent study and extension study weeks 24 and 52

Parent Study Baseline

Group	Value	95% CI
Standard of Care	113.2	± 25.3
Evolocumab + SOC	110.4	± 23.8
Control in Parent Study: SOC	115.4	± 23.1
Control in Parent Study: Evolocumab + SOC	110.3	± 22.4
Evolocumab in Parent Study: SOC	112.4	± 26.0
Evolocumab in Parent Study: Evolocumab + SOC	110.4	± 24.3

Week 24

Group	Value	95% CI
Standard of Care	107.9	± 26.3
Evolocumab + SOC	60.8	± 23.3
Control in Parent Study: SOC	110.5	± 27.0
Control in Parent Study: Evolocumab + SOC	60.7	± 23.9
Evolocumab in Parent Study: SOC	106.9	± 26.0
Evolocumab in Parent Study: Evolocumab + SOC	60.9	± 23.1

Week 52

Group	Value	95% CI
Standard of Care	109.5	± 26.8
Evolocumab + SOC	61.6	± 23.5
Control in Parent Study: SOC	110.7	± 26.3
Control in Parent Study: Evolocumab + SOC	61.7	± 23.0
Evolocumab in Parent Study: SOC	109.1	± 27.0
Evolocumab in Parent Study: Evolocumab + SOC	61.6	± 23.7

Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 Secondary · Baseline of parent study and extension study weeks 24 and 52

Parent Study Baseline

Group	Value	95% CI
Standard of Care	4.516	± 1.617
Evolocumab + SOC	4.386	± 1.393
Control in Parent Study: SOC	4.458	± 1.345
Control in Parent Study: Evolocumab + SOC	4.388	± 1.340
Evolocumab in Parent Study: SOC	4.538	± 1.708
Evolocumab in Parent Study: Evolocumab + SOC	4.386	± 1.413

Week 24

Group	Value	95% CI
Standard of Care	4.198	± 1.536
Evolocumab + SOC	2.603	± 0.978
Control in Parent Study: SOC	4.192	± 1.408
Control in Parent Study: Evolocumab + SOC	2.594	± 0.970
Evolocumab in Parent Study: SOC	4.201	± 1.584
Evolocumab in Parent Study: Evolocumab + SOC	2.607	± 0.982

Week 52

Group	Value	95% CI
Standard of Care	4.277	± 1.652
Evolocumab + SOC	2.626	± 1.025
Control in Parent Study: SOC	4.252	± 1.434
Control in Parent Study: Evolocumab + SOC	2.622	± 1.033
Evolocumab in Parent Study: SOC	4.286	± 1.733
Evolocumab in Parent Study: Evolocumab + SOC	2.628	± 1.023

Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 Secondary · Baseline of parent study and extension study weeks 24 and 52

Parent Study Baseline

Group	Value	95% CI
Standard of Care	0.759	± 0.237
Evolocumab + SOC	0.739	± 0.217
Control in Parent Study: SOC	0.764	± 0.201
Control in Parent Study: Evolocumab + SOC	0.735	± 0.212
Evolocumab in Parent Study: SOC	0.757	± 0.249
Evolocumab in Parent Study: Evolocumab + SOC	0.741	± 0.218

Week 24

Group	Value	95% CI
Standard of Care	0.717	± 0.242
Evolocumab + SOC	0.386	± 0.178
Control in Parent Study: SOC	0.715	± 0.222
Control in Parent Study: Evolocumab + SOC	0.385	± 0.183
Evolocumab in Parent Study: SOC	0.718	± 0.250
Evolocumab in Parent Study: Evolocumab + SOC	0.387	± 0.176

Week 52

Group	Value	95% CI
Standard of Care	0.726	± 0.256
Evolocumab + SOC	0.394	± 0.185
Control in Parent Study: SOC	0.719	± 0.216
Control in Parent Study: Evolocumab + SOC	0.393	± 0.186
Evolocumab in Parent Study: SOC	0.729	± 0.271
Evolocumab in Parent Study: Evolocumab + SOC	0.394	± 0.185

Adverse events — posted to ClinicalTrials.gov

Time frame: 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SOC-controlled Period: SOC

Serious: 30/442 (7%)

Deaths: 2/442

SOC-controlled Period: Evolocumab + SOC

Serious: 72/882 (8%)

Deaths: 1/882

All-IP Period: SOC / Evolocumab

Serious: 78/398 (20%)

Deaths: 3/398

All-IP Period: Evolocumab + SOC / Evolocumab

Serious: 181/822 (22%)

Deaths: 13/822

All-IP Period: Total

Serious: 259/1220 (21%)

Deaths: 16/1220

Serious adverse events (345 terms)

Reaction	System	SOC-controlled Period: SOC	SOC-controlled Period: Evo…	All-IP Period: SOC / Evolo…	All-IP Period: Evolocumab …	All-IP Period: Total
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Angina pectoris	Cardiac disorders	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Cataract	Eye disorders	—	—	—	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—
Pyelonephritis	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Femur fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Wrist fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Spinal column stenosis	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—

Other adverse events (23 terms — click to expand)

Reaction	System	SOC-controlled Period: SOC	SOC-controlled Period: Evo…	All-IP Period: SOC / Evolo…	All-IP Period: Evolocumab …	All-IP Period: Total
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—	—

Most-reported serious reactions: Osteoarthritis, Angina pectoris, Atrial fibrillation, Chest pain, Non-cardiac chest pain, Coronary artery disease, Pneumonia, Breast cancer.

Data from ClinicalTrials.gov NCT01439880 adverse events section.

Sponsor's own description

The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and safety of evolocumab in reducing lipids and cardiovascular events.
Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, et al · · 2015 · cited 1125× · PMID 25773607 · DOI 10.1056/nejmoa1500858
Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 in combination with a statin in patients with hypercholesterolaemia (LAPLACE-TIMI 57): a randomised, placebo-controlled, dose-ranging, phase 2 study.
Giugliano RP, Desai NR, Kohli P, Rogers WJ, et al · · 2012 · cited 329× · PMID 23141813 · DOI 10.1016/s0140-6736(12)61770-x
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.
Koren MJ, Giugliano RP, Raal FJ, Sullivan D, et al · · 2014 · cited 162× · PMID 24255061 · DOI 10.1161/circulationaha.113.007012
Long-Term Efficacy and Safety of Evolocumab in Patients With Hypercholesterolemia.
Koren MJ, Sabatine MS, Giugliano RP, Langslet G, et al · · 2019 · cited 105× · PMID 31648705 · DOI 10.1016/j.jacc.2019.08.1024
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.
Koren MJ, Sabatine MS, Giugliano RP, Langslet G, et al · · 2017 · cited 101× · PMID 28291870 · DOI 10.1001/jamacardio.2017.0747
Antibodies to watch in 2014.
Reichert JM. · · 2014 · cited 82× · PMID 24284914 · DOI 10.4161/mabs.27333
PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.
Schmidt AF, Pearce LS, Wilkins JT, Overington JP, et al · · 2017 · cited 78× · PMID 28453187 · DOI 10.1002/14651858.cd011748.pub2
PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.
Schmidt AF, Carter JL, Pearce LS, Wilkins JT, et al · · 2020 · cited 56× · PMID 33078867 · DOI 10.1002/14651858.cd011748.pub3

Verify or expand the search:

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Currently open trials in the same condition.

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Other Amgen trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01439880 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 21 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01439880.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01439880: OSLER

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (345 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Evolocumab

Other recruiting trials for Hypercholesterolemia

Other Amgen trials

Verify against primary sources