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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
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hyperlipidemia and Mixed Dyslipidemia Biological: evolocumab (AMG 145) and standard of care Other: Standard of care Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Subject incidence of adverse events [ Time Frame: 156 weeks ]

Secondary Outcome Measures :
  1. Percent change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: Weeks 48 & 104 ]
  2. Change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: Weeks 48 & 104 ]

Eligibility Criteria
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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
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 contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854918


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Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information
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Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

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