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Open Label Study of Long Term Evaluation Against LDL-C Trial-2 (OSLER-2)
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01854918
First received: May 1, 2013
Last updated: June 14, 2017
Last verified: June 2017
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Purpose
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in subjects with hyperlipidemia and subjects with mixed dyslipidemia.
| Condition | Intervention | Phase |
|---|---|---|
| Hyperlipidemia and Mixed Dyslipidemia | Biological: evolocumab (AMG 145) and standard of care Other: Standard of care | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Subject incidence of adverse events [ Time Frame: 156 weeks ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 3681 |
| Actual Study Start Date: | April 23, 2013 |
| Estimated Study Completion Date: | August 27, 2018 |
| Estimated Primary Completion Date: | August 27, 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: evolocumab (AMG 145) and standard of care
evolocumab (AMG 145) and standard of care
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01854918
Show 363 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01854918
Show 363 Study Locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
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 |
| Study First Received: | May 1, 2013 |
| Last Updated: | June 14, 2017 |
Keywords provided by Amgen:
|
High cholesterol Raised cholesterol Cholesterol Elevated Cholesterol |
Additional relevant MeSH terms:
|
Dyslipidemias Hyperlipidemias Hyperlipoproteinemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on July 24, 2017