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

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ClinicalTrials.gov Identifier: NCT01439880
Recruitment Status : Active, not recruiting
First Posted : September 23, 2011
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1324 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 (Evolocumab)
Actual Study Start Date : October 7, 2011
Estimated Primary Completion Date : June 27, 2018
Estimated Study Completion Date : June 27, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

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




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

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


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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)

Information from the National Library of Medicine

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): NCT01439880


  Show 187 Study Locations
Sponsors and Collaborators
Amgen
Investigators
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: NCT01439880     History of Changes
Other Study ID Numbers: 20110110
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs