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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: July 8, 2014
Last verified: July 2014

September 22, 2011
July 8, 2014
October 2011
February 2016   (final data collection date for primary outcome measure)
Subject incidence of treatment emergent adverse events [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]
Same as current
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 ] [ Designated as safety issue: No ]
  • Absolute non-high density lipoprotein cholesterol (non-HDL-C) at week 24 and week 52 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Absolute apolipoprotein B (ApoB) at week 24 and week 52 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Absolute total cholesterol/high density lipoprotein cholesterol (HDL-C) ratio at week 24 and week 52 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Absolute Apolipoprotein B (ApoeB)/Apolipoprotein A1 (ApoA1) ratio at week 24 and week 52 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Absolute high density lipoprotein cholesterol (hDL-C) at week 24 and week 52 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Absolute apolipoprotein B (ApoB) at week 24 and week 52 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Absolute total cholesterol/HDL-C ratio at week 24 and week 52 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Absolute ApoB/Apolipoprotein A-1 (ApoA1) ratio at week 24 and week 52 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
  • Absolute low density lipoprotein cholesterol (LDL-C) at week 24 and week 52 [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
    ASSIGNED TO [1] INTERVENTION(S)
    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
Koren MJ, Giugliano RP, Raal FJ, Sullivan D, Bolognese M, Langslet G, Civeira F, Somaratne R, Nelson P, Liu T, Scott R, Wasserman SM, Sabatine MS; OSLER Investigators. Efficacy and safety of longer-term administration of evolocumab (AMG 145) in patients with hypercholesterolemia: 52-week results from the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER) randomized trial. Circulation. 2014 Jan 14;129(2):234-43. doi: 10.1161/CIRCULATIONAHA.113.007012. Epub 2013 Nov 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1324
January 2017
February 2016   (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)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Czech Republic,   Denmark,   Finland,   Germany,   Hong Kong,   Hungary,   Japan,   Netherlands,   Norway,   Singapore,   South Africa,   Spain,   Sweden,   United Kingdom
 
NCT01439880
20110110
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

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