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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01854918
Registration number
NCT01854918
Ethics application status
Date submitted
1/05/2013
Date registered
16/05/2013
Date last updated
11/06/2019
Titles & IDs
Public title
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
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Scientific title
A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145
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Secondary ID [1]
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2012-004357-83
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Secondary ID [2]
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20120138
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Universal Trial Number (UTN)
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Trial acronym
OSLER-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hyperlipidemia and Mixed Dyslipidemia
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Blood
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Other blood disorders
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Evolocumab
Treatment: Drugs - Standard of Care
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.
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.
Treatment: Other: Evolocumab
Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
Treatment: Drugs: Standard of Care
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events
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Assessment method [1]
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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.
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Timepoint [1]
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48 weeks in the SOC-controlled period and up to 2 years in the All-IP period
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Secondary outcome [1]
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Percent Change From Baseline in LDL-C at Weeks 48 and 104
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Assessment method [1]
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Timepoint [1]
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Baseline of the parent study and weeks 48 amd 104
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Secondary outcome [2]
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Change From Baseline in LDL-C at Weeks 48 and 104
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Assessment method [2]
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Timepoint [2]
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Baseline of the parent study and weeks 48 amd 104
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Eligibility
Key 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]).
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Minimum age
18
Years
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/04/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/05/2018
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Sample size
Target
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Accrual to date
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Final
3681
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Research Site - Camperdown
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2015 - Camperdown
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2035 - Maroubra
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2010 - Sydney
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2022 - Sydney
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4066 - Auchenflower
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4152 - Carina Heights
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4075 - Sherwood
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4102 - Woolloongabba
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5035 - Ashford
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5063 - Fullarton
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3081 - Heidelberg Heights
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3004 - Melbourne
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6000 - Perth
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Gunma
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Kyoto
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Tokyo
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Russian Federation
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Lund
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Doncaster
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Reading
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Whitby
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Amgen
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Address
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Country
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01854918
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Trial related presentations / publications
Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521-1527. doi: 10.1016/j.amjcard.2017.07.047. Epub 2017 Jul 31. Hovingh GK, Raal FJ, Dent R, Stefanutti C, Descamps O, Masana L, Lira A, Bridges I, Coll B, Sullivan D. Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1448-1457. doi: 10.1016/j.jacl.2017.09.003. Epub 2017 Sep 22. Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3. Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, Ballantyne CM, Somaratne R, Legg J, Wasserman SM, Scott R, Koren MJ, Stein EA; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1500-9. doi: 10.1056/NEJMoa1500858. Epub 2015 Mar 15.
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Public notes
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Contacts
Principal investigator
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MD
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Amgen
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/18/NCT01854918/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/18/NCT01854918/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uha...
[
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Journal
Hovingh GK, Raal FJ, Dent R, Stefanutti C, Descamp...
[
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Results are available at
https://clinicaltrials.gov/study/NCT01854918
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