Open Label Study of Long Term Evaluation Against LDL-C Trial-2 (OSLER-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01854918
First received: May 1, 2013
Last updated: June 25, 2015
Last verified: June 2015

May 1, 2013
June 25, 2015
April 2013
May 2018   (final data collection date for primary outcome measure)
Subject incidence of adverse events [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
Subject incidence of adverse events [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01854918 on ClinicalTrials.gov Archive Site
  • Percent change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: Weeks 48 & 104 ] [ Designated as safety issue: No ]
  • Change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: Weeks 48 & 104 ] [ Designated as safety issue: No ]
  • Percent change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Open Label Study of Long Term Evaluation Against LDL-C Trial-2
A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145-2

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hyperlipidemia and Mixed Dyslipidemia
  • 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
Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, Ballantyne CM, Somaratne R, Legg J, Wasserman SM, Scott R, Koren MJ, Stein EA; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1500-9. doi: 10.1056/NEJMoa1500858. Epub 2015 Mar 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4428
May 2018
May 2018   (final data collection date for primary outcome measure)

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)
Both
18 Years to 85 Years
No
Contact: Amgen Call Center 866-572-6436
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Hong Kong,   Hungary,   Italy,   Japan,   Korea, Republic of,   Netherlands,   New Zealand,   Norway,   Poland,   Russian Federation,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom
 
NCT01854918
20120138
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
June 2015

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