Open Label Study of Long Term Evaluation Against LDL-C Trial-2 (OSLER-2)
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ClinicalTrials.gov Identifier: NCT01854918 |
Recruitment Status :
Completed
First Posted : May 16, 2013
Last Update Posted : November 2, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyperlipidemia and Mixed Dyslipidemia | Biological: evolocumab (AMG 145) and standard of care Other: Standard of care | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3681 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145-2 |
Actual Study Start Date : | April 23, 2013 |
Actual Primary Completion Date : | May 18, 2018 |
Actual Study Completion Date : | May 18, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: evolocumab (AMG 145) and standard of care
evolocumab (AMG 145) and standard of care
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Biological: evolocumab (AMG 145) and standard of care
evolocumab (AMG 145) is a fully human monoclonal antibody against PCSK9. Standard of care therapy is per local practice; this could include prescribed therapies and/or dietary/exercise regimes |
Active Comparator: Standard of care
Standard of care therapy as per local practice
|
Other: Standard of care
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes |
- Subject incidence of adverse events [ Time Frame: 156 weeks ]
- Percent change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: Weeks 48 & 104 ]
- Change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: Weeks 48 & 104 ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Complete a qualifying evolocumab (AMG 145) parent study
Exclusion Criteria:
- Experienced a treatment-related serious adverse event that led to 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854918

Study Director: | MD | Amgen |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT01854918 History of Changes |
Other Study ID Numbers: |
20120138 |
First Posted: | May 16, 2013 Key Record Dates |
Last Update Posted: | November 2, 2018 |
Last Verified: | November 2018 |
Keywords provided by Amgen:
High cholesterol Raised cholesterol Cholesterol Elevated Cholesterol |
Additional relevant MeSH terms:
Dyslipidemias Hyperlipidemias Hyperlipoproteinemias Lipid Metabolism Disorders |
Metabolic Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |