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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:
ClinicalTrials.gov Identifier:
NCT01439880
First Posted: September 23, 2011
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
September 22, 2011
September 23, 2011
June 14, 2017
October 7, 2011
June 27, 2018   (Final data collection date for primary outcome measure)
Subject incidence of treatment emergent adverse events [ Time Frame: Approximately 5 year ]
Subject incidence of treatment emergent adverse events [ Time Frame: Approximately 1 year ]
Complete list of historical versions of study NCT01439880 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Absolute high density lipoprotein cholesterol (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/HDL-C ratio at week 24 and week 52 [ Time Frame: Approximately 1 year ]
  • Absolute ApoB/Apolipoprotein A-1 (ApoA1) ratio at week 24 and week 52 [ Time Frame: Approximately 1 year ]
  • Absolute low density lipoprotein cholesterol (LDL-C) at week 24 and week 52 [ Time Frame: Approximately 1 year ]
Not Provided
Not Provided
 
Open Label Study of Long Term Evaluation Against LDL-C Trial
A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145 (Evolocumab)
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in subjects with hypercholesterolemia.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypercholesterolemia
  • 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
  • Other: Standard of care
    Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
  • Experimental: Evolocumab (AMG 145) and standard of care
    Evolocumab (AMG 145) and standard of care
    Intervention: Biological: Evolocumab (AMG 145) and standard of care
  • Active Comparator: Standard of care
    Standard of care therapy as per local practice
    Intervention: Other: Standard of care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1324
June 27, 2018
June 27, 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   Czechia,   Denmark,   Finland,   Germany,   Hong Kong,   Hungary,   Japan,   Netherlands,   Norway,   Singapore,   South Africa,   Spain,   Sweden,   United Kingdom,   United States
Czech Republic
 
NCT01439880
20110110
No
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP