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Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab

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ClinicalTrials.gov Identifier: NCT02304484
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE October 7, 2014
First Posted Date  ICMJE December 2, 2014
Results First Submitted Date  ICMJE February 27, 2019
Results First Posted Date  ICMJE March 19, 2019
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE November 24, 2014
Actual Primary Completion Date March 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
Number of Participants With Adverse Events [ Time Frame: From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks. ]
The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE. An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser [AMD]), including but not limited to, AEs resulting from insufficient or inadequate Instructions for Use, AEs resulting from any malfunction of the device, or AEs resulting from use error or from intentional misuse of the device.
Original Primary Outcome Measures  ICMJE
 (submitted: November 26, 2014)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: after all subjects complete week 52 ]
Subject incidence of adverse events
Change History Complete list of historical versions of study NCT02304484 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2014)
Low density lipoprotein cholesterol (LDL-C) at week 52 [ Time Frame: after week 52 for all subjects ]
LDL-C at week 52
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
Official Title  ICMJE A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab
Brief Summary The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE Biological: Evolocumab
Administered by subcutaneous injection once a month
Other Names:
  • AMG 145
  • Repatha
Study Arms  ICMJE Experimental: Evolocumab
Participants received 420 mg evolocumab once a month for up to 2 years.
Intervention: Biological: Evolocumab
Publications * Not Provided

*   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: August 19, 2016)
770
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2014)
642
Actual Study Completion Date  ICMJE March 9, 2018
Actual Primary Completion Date March 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Completed week 80 of study 20120153 (NCT01813422).

Exclusion Criteria:

  • Did not complete investigational product in the 20120153 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 99 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 Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   Czechia,   France,   Germany,   Greece,   Hungary,   Iceland,   Ireland,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Norway,   Poland,   Russian Federation,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02304484
Other Study ID Numbers  ICMJE 20140128
2014-001524-30 ( EudraCT Number )
Has Data Monitoring Committee Yes
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 February 2019

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