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 July 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01854918
First received: May 1, 2013
Last updated: July 30, 2014
Last verified: July 2014

May 1, 2013
July 30, 2014
April 2013
July 2016   (final data collection date for primary outcome measure)
Subject incidence of adverse events [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
Same as current
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: 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 ]
Same as current
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
    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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3515
January 2017
July 2016   (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
July 2014

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