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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02304484




Registration number
NCT02304484
Ethics application status
Date submitted
7/10/2014
Date registered
2/12/2014
Date last updated
19/03/2019

Titles & IDs
Public title
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
Scientific title
A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab
Secondary ID [1] 0 0
2014-001524-30
Secondary ID [2] 0 0
20140128
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

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

Experimental: Evolocumab - Participants received 420 mg evolocumab once a month for up to 2 years.


Other interventions: Evolocumab
Administered by subcutaneous injection once a month

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events - 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.
Timepoint [1] 0 0
From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks.
Secondary outcome [1] 0 0
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Timepoint [1] 0 0
Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128

Eligibility
Key inclusion criteria
- Completed week 80 of study 20120153 (NCT01813422).
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Liverpool
Recruitment hospital [2] 0 0
Research Site - New Lambton Heights
Recruitment hospital [3] 0 0
Research Site - Chermside
Recruitment hospital [4] 0 0
Research Site - Herston
Recruitment hospital [5] 0 0
Research Site - Adelaide
Recruitment hospital [6] 0 0
Research Site - Fullarton
Recruitment hospital [7] 0 0
Research Site - Epping
Recruitment hospital [8] 0 0
Research Site - Footscray
Recruitment hospital [9] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
5063 - Fullarton
Recruitment postcode(s) [7] 0 0
3076 - Epping
Recruitment postcode(s) [8] 0 0
3011 - Footscray
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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Argentina
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Buenos Aires
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Córdoba
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Antwerpen
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Belgium
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Edegem
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Genk
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Hasselt
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Manitoba
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Stockholm
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Geneva 14
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Taiwan
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New Taipei
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United Kingdom
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Newcastle Upon Tyne

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02304484
Trial related presentations / publications
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

Summary results
Other publications