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Trial record 1 of 1 for:    NCT01439880
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Open Label Study of Long Term Evaluation Against LDL-C Trial (OSLER)

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.
 
ClinicalTrials.gov Identifier: NCT01439880
Recruitment Status : Completed
First Posted : September 23, 2011
Results First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE September 22, 2011
First Posted Date  ICMJE September 23, 2011
Results First Submitted Date  ICMJE June 17, 2019
Results First Posted Date  ICMJE July 10, 2019
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE October 7, 2011
Actual Primary Completion Date June 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
Number of Participants With Adverse Events [ Time Frame: 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months. ]
Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.03, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2011)
Subject incidence of treatment emergent adverse events [ Time Frame: Approximately 1 year ]
Change History Complete list of historical versions of study NCT01439880 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52 [ Time Frame: Baseline of parent study and extension study weeks 24 and 52 ]
  • Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52 [ Time Frame: Baseline of parent study and extension study weeks 24 and 52 ]
  • Apolipoprotein B Level at Week 24 and Week 52 [ Time Frame: Baseline of parent study and extension study weeks 24 and 52 ]
  • Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 [ Time Frame: Baseline of parent study and extension study weeks 24 and 52 ]
  • Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 [ Time Frame: Baseline of parent study and extension study weeks 24 and 52 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2011)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Study of Long Term Evaluation Against LDL-C Trial
Official Title  ICMJE A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145 (Evolocumab)
Brief Summary The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Biological: Evolocumab
    Administered by subcutaneous injection
    Other Names:
    • AMG 145
    • Repatha
  • Other: Standard of care
    Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Study Arms  ICMJE
  • Active Comparator: Standard of Care
    Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 52 participants began treatment with evolocumab 420 mg once a month (QM) for 4 years during the all-investigational product [all-IP] period.
    Interventions:
    • Biological: Evolocumab
    • Other: Standard of care
  • Experimental: Evolocumab + SOC
    Participants received evolocumab 420 mg once a month plus standard of care for the first year of the study (SOC-controlled period). At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period.
    Intervention: Biological: Evolocumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2014)
1324
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2011)
375
Actual Study Completion Date  ICMJE June 20, 2018
Actual Primary Completion Date June 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703)

Exclusion Criteria:

  • Experienced a treatment-related serious adverse event that led to investigational product (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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Czechia,   Denmark,   Finland,   Germany,   Hong Kong,   Hungary,   Japan,   Netherlands,   Norway,   Singapore,   South Africa,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01439880
Other Study ID Numbers  ICMJE 20110110
2011-001915-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date June 2019

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