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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01439880
First received: September 22, 2011
Last updated: December 16, 2016
Last verified: December 2016
  Purpose
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in subjects with hypercholesterolemia.

Condition Intervention Phase
Hypercholesterolemia
Biological: Evolocumab (AMG 145) and standard of care
Other: Standard of care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 (Evolocumab)

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Subject incidence of treatment emergent adverse events [ Time Frame: Approximately 5 year ]

Secondary Outcome Measures:
  • Absolute low density lipoprotein cholesterol (LDL-C) at week 24 and week 52 [ Time Frame: Approximately 1 year ]
  • Absolute non-high density lipoprotein cholesterol (non-HDL-C) at week 24 and week 52 [ Time Frame: Approximately 1 year ]
  • Absolute apolipoprotein B (ApoB) at week 24 and week 52 [ Time Frame: Approximately 1 year ]
  • Absolute total cholesterol/high density lipoprotein cholesterol (HDL-C) ratio at week 24 and week 52 [ Time Frame: Approximately 1 year ]
  • Absolute Apolipoprotein B (ApoeB)/Apolipoprotein A1 (ApoA1) ratio at week 24 and week 52 [ Time Frame: Approximately 1 year ]

Enrollment: 1324
Study Start Date: October 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Evolocumab (AMG 145) and standard of care
ASSIGNED TO [1] INTERVENTION(S)
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 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complete a qualifying evolocumab (AMG 145) parent study protocol

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT01439880

  Show 187 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01439880     History of Changes
Other Study ID Numbers: 20110110 
Study First Received: September 22, 2011
Last Updated: December 16, 2016

Keywords provided by Amgen:
High cholesterol
Raised cholesterol
Cholesterol
Elevated Cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on February 27, 2017