Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - Evolocumab

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


Treatment: Other: Evolocumab
Administered by subcutaneous injection once a month
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events
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
Sex
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
Not applicable
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
24/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/03/2018
Sample size
Target
Accrual to date
Final
770
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
North Dakota
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Córdoba
Country [18] 0 0
Belgium
State/province [18] 0 0
Antwerpen
Country [19] 0 0
Belgium
State/province [19] 0 0
Edegem
Country [20] 0 0
Belgium
State/province [20] 0 0
Genk
Country [21] 0 0
Belgium
State/province [21] 0 0
Hasselt
Country [22] 0 0
Belgium
State/province [22] 0 0
Lodelinsart
Country [23] 0 0
Brazil
State/province [23] 0 0
Rio Grande Do Sul
Country [24] 0 0
Brazil
State/province [24] 0 0
São Paulo
Country [25] 0 0
Canada
State/province [25] 0 0
Alberta
Country [26] 0 0
Canada
State/province [26] 0 0
British Columbia
Country [27] 0 0
Canada
State/province [27] 0 0
Manitoba
Country [28] 0 0
Canada
State/province [28] 0 0
Newfoundland and Labrador
Country [29] 0 0
Canada
State/province [29] 0 0
Nova Scotia
Country [30] 0 0
Canada
State/province [30] 0 0
Ontario
Country [31] 0 0
Canada
State/province [31] 0 0
Quebec
Country [32] 0 0
Chile
State/province [32] 0 0
Cautín
Country [33] 0 0
Czechia
State/province [33] 0 0
Brno
Country [34] 0 0
Czechia
State/province [34] 0 0
Hradec Kralove
Country [35] 0 0
Czechia
State/province [35] 0 0
Praha 2
Country [36] 0 0
Czechia
State/province [36] 0 0
Zlin
Country [37] 0 0
France
State/province [37] 0 0
Besancon cedex
Country [38] 0 0
France
State/province [38] 0 0
Chambray les Tours
Country [39] 0 0
France
State/province [39] 0 0
Marseille cedex 5
Country [40] 0 0
France
State/province [40] 0 0
Paris
Country [41] 0 0
France
State/province [41] 0 0
Pessac Cedex
Country [42] 0 0
Germany
State/province [42] 0 0
Essen
Country [43] 0 0
Greece
State/province [43] 0 0
Athens
Country [44] 0 0
Greece
State/province [44] 0 0
Heraklion
Country [45] 0 0
Hungary
State/province [45] 0 0
Budapest
Country [46] 0 0
Hungary
State/province [46] 0 0
Debrecen
Country [47] 0 0
Hungary
State/province [47] 0 0
Szeged
Country [48] 0 0
Iceland
State/province [48] 0 0
Reykjavik
Country [49] 0 0
Ireland
State/province [49] 0 0
Galway
Country [50] 0 0
Israel
State/province [50] 0 0
Hadera
Country [51] 0 0
Israel
State/province [51] 0 0
Jerusalem
Country [52] 0 0
Italy
State/province [52] 0 0
Novara
Country [53] 0 0
Italy
State/province [53] 0 0
Rozzano MI
Country [54] 0 0
Italy
State/province [54] 0 0
Sesto San Giovanni (MI)
Country [55] 0 0
Italy
State/province [55] 0 0
Torino
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Daejeon
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Seongnam-si, Gyeonggi-do
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Seoul
Country [59] 0 0
Malaysia
State/province [59] 0 0
Pahang
Country [60] 0 0
Malaysia
State/province [60] 0 0
Penang
Country [61] 0 0
Mexico
State/province [61] 0 0
Jalisco
Country [62] 0 0
Mexico
State/province [62] 0 0
San Luis Potosí
Country [63] 0 0
Mexico
State/province [63] 0 0
Sinaloa
Country [64] 0 0
Mexico
State/province [64] 0 0
Aguascalientes
Country [65] 0 0
Netherlands
State/province [65] 0 0
Alkmaar
Country [66] 0 0
Netherlands
State/province [66] 0 0
Amsterdam
Country [67] 0 0
Netherlands
State/province [67] 0 0
Leeuwarden
Country [68] 0 0
Netherlands
State/province [68] 0 0
Nijmegen
Country [69] 0 0
Netherlands
State/province [69] 0 0
Rotterdam
Country [70] 0 0
Netherlands
State/province [70] 0 0
Tilburg
Country [71] 0 0
Netherlands
State/province [71] 0 0
Utrecht
Country [72] 0 0
Netherlands
State/province [72] 0 0
Zwolle
Country [73] 0 0
Norway
State/province [73] 0 0
Oslo
Country [74] 0 0
Poland
State/province [74] 0 0
Chrzanow
Country [75] 0 0
Poland
State/province [75] 0 0
Kedzierzyn Kozle
Country [76] 0 0
Poland
State/province [76] 0 0
Krakow
Country [77] 0 0
Poland
State/province [77] 0 0
Lodz
Country [78] 0 0
Poland
State/province [78] 0 0
Warszawa
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Kemerovo
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Moscow
Country [81] 0 0
South Africa
State/province [81] 0 0
Gauteng
Country [82] 0 0
South Africa
State/province [82] 0 0
Western Cape
Country [83] 0 0
Spain
State/province [83] 0 0
Andalucía
Country [84] 0 0
Spain
State/province [84] 0 0
Asturias
Country [85] 0 0
Spain
State/province [85] 0 0
Cataluña
Country [86] 0 0
Spain
State/province [86] 0 0
Madrid
Country [87] 0 0
Sweden
State/province [87] 0 0
Göteborg
Country [88] 0 0
Sweden
State/province [88] 0 0
Stockholm
Country [89] 0 0
Switzerland
State/province [89] 0 0
Geneva 14
Country [90] 0 0
Taiwan
State/province [90] 0 0
New Taipei
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Newcastle Upon Tyne

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02304484