This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01854918
First received: May 1, 2013
Last updated: June 14, 2017
Last verified: June 2017
May 1, 2013
June 14, 2017
April 23, 2013
August 27, 2018   (Final data collection date for primary outcome measure)
Subject incidence of adverse events [ Time Frame: 156 weeks ]
Subject incidence of adverse events [ Time Frame: 104 weeks ]
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 ]
  • Change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: Weeks 48 & 104 ]
  • Percent change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: 104 weeks ]
  • Change from baseline in LDL-C at weeks 48 and 104 [ Time Frame: 104 weeks ]
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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Active, not recruiting
3681
August 27, 2018
August 27, 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)
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Canada,   Czechia,   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,   United States
Czech Republic
 
NCT01854918
20120138
Yes
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