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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145
Secondary ID [1] 0 0
2012-004357-83
Secondary ID [2] 0 0
20120138
Universal Trial Number (UTN)
Trial acronym
OSLER-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperlipidemia and Mixed Dyslipidemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - 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.


Other interventions: 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
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events
Timepoint [1] 0 0
48 weeks in the SOC-controlled period and up to 2 years in the All-IP period
Secondary outcome [1] 0 0
Percent Change From Baseline in LDL-C at Weeks 48 and 104
Timepoint [1] 0 0
Baseline of the parent study and weeks 48 amd 104
Secondary outcome [2] 0 0
Change From Baseline in LDL-C at Weeks 48 and 104
Timepoint [2] 0 0
Baseline of the parent study and weeks 48 amd 104

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]).
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2018
Sample size
Target
Accrual to date
Final
3681
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Research Site - Camperdown
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2015 - Camperdown
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2035 - Maroubra
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4066 - Auchenflower
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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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Whitby

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01854918
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.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries