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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 : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Biological: Evolocumab Other: Standard of care Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1324 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 (Evolocumab)
Actual Study Start Date : October 7, 2011
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : June 20, 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 52 participants began treatment with evolocumab 420 mg once a month (QM) for 4 years during the all-investigational product [all-IP] period.
 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
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.
 Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • AMG 145
  • Repatha


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Apolipoprotein B Level at Week 24 and Week 52 [ Time Frame: Baseline of parent study and extension study weeks 24 and 52 ]
  4. Total Cholesterol/HDL-C Ratio at Week 24 and Week 52 [ Time Frame: Baseline of parent study and extension study weeks 24 and 52 ]
  5. Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52 [ Time Frame: Baseline of parent study and extension study weeks 24 and 52 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
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): NCT01439880


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] November 12, 2015
Statistical Analysis Plan  [PDF] February 22, 2018

More Information
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Additional Information:

Publications:

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

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01439880    
Other Study ID Numbers: 20110110
2011-001915-29 ( EudraCT Number )
First Posted: September 23, 2011    Key Record Dates
Results First Posted: July 10, 2019
Last Update Posted: September 21, 2022
Last Verified: September 2022
Keywords provided by Amgen:
High cholesterol
Raised cholesterol
Cholesterol
Elevated Cholesterol
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Evolocumab
PCSK9 Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Lipid Regulating Agents