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Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia (OSLER-2)

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: NCT01854918
Recruitment Status : Completed
First Posted : May 16, 2013
Results First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

Condition or disease Intervention/treatment Phase
Hyperlipidemia and Mixed Dyslipidemia Biological: Evolocumab Drug: Standard of Care Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3681 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145
Actual Study Start Date : April 23, 2013
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard of Care
Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product [all-IP] period.
 Biological: Evolocumab
Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
Other Names:
  • AMG 145
  • Repatha

Drug: Standard of Care
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Experimental: Evolocumab + Standard of Care
Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
 Biological: Evolocumab
Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
Other Names:
  • AMG 145
  • Repatha

Drug: Standard of Care
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period ]
    Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.0, 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.


Secondary Outcome Measures :
  1. Percent Change From Baseline in LDL-C at Weeks 48 and 104 [ Time Frame: Baseline of the parent study and weeks 48 amd 104 ]
  2. Change From Baseline in LDL-C at Weeks 48 and 104 [ Time Frame: Baseline of the parent study and weeks 48 amd 104 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114 [NCT01763827], 20110115 [NCT01763866], 20110116 [NCT01763905], 20110117 [NCT01763918], 20110109 [NCT01516879], 20120122 [NCT01953328], 20120332 [NCT01984424], 20120348 [NCT01849497], or 20120356 [NCT01879319]).

Exclusion Criteria:

  • Experienced a treatment-related serious adverse event that led to study drug 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854918


Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] April 3, 2015
Statistical Analysis Plan  [PDF] November 18, 2013

More Information
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Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01854918    
Other Study ID Numbers: 20120138
2012-004357-83 ( EudraCT Number )
First Posted: May 16, 2013    Key Record Dates
Results First Posted: June 11, 2019
Last Update Posted: June 11, 2019
Last Verified: May 2019
Keywords provided by Amgen:
High cholesterol
Raised cholesterol
Cholesterol
Elevated Cholesterol
Additional relevant MeSH terms:
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Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Metabolic Diseases
Evolocumab
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents