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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00902928




Registration number
NCT00902928
Ethics application status
Date submitted
30/04/2009
Date registered
15/05/2009
Date last updated
27/10/2015

Titles & IDs
Public title
A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery
Scientific title
A Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Compare YM150 Bid and qd Doses and Enoxaparin for Prevention of Venous Thromboembolism in Subjects Undergoing Elective Hip Replacement Surgery
Secondary ID [1] 0 0
2008-004416-13
Secondary ID [2] 0 0
150-CL-040
Universal Trial Number (UTN)
Trial acronym
ONYX-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Arthroplasty, Replacement, Hip 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - YM150
Treatment: Drugs - enoxaparin

Experimental: 1. YM150, Dose X, twice daily -

Experimental: 2, YM150, Dose X, once daily -

Experimental: 3. YM150, Dose Y, twice daily -

Experimental: 4. YM150, Dose Y, once daily -

Active comparator: 5. Enoxaparin -


Treatment: Drugs: YM150
oral

Treatment: Drugs: enoxaparin
SC injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of symptomatic Venous Thromboembolisms and death from all causes
Timepoint [1] 0 0
12 days
Secondary outcome [1] 0 0
Incidence of all Venous Thromboembolic events
Timepoint [1] 0 0
Until day 12, during the treatment period, follow-up period and entire study period
Secondary outcome [2] 0 0
Incidence of Bleeding events
Timepoint [2] 0 0
During the treatment period, follow-up period and entire study period

Eligibility
Key inclusion criteria
* Subject is scheduled for elective hip replacement surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject has active bleeding or any condition associated with increased risk of bleeding
* Subject has had major trauma or surgery within 3 months before planned hip replacement surgery or requires major surgery or other invasive procedures with potential for uncontrolled bleeding during the study
* Subject has had an MI or stroke within 3 months before planned hip replacement surgery

Study design
Purpose of the study
Prevention
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
1992
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
- Box Hill
Recruitment hospital [2] 0 0
- Ringwood East
Recruitment hospital [3] 0 0
- Windsor
Recruitment hospital [4] 0 0
- Perth
Recruitment hospital [5] 0 0
- Kogarah
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3135 - Ringwood East
Recruitment postcode(s) [3] 0 0
3181 - Windsor
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment postcode(s) [5] 0 0
2217 - Kogarah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
Arkansas
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United States of America
State/province [3] 0 0
California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Idaho
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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South Carolina
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United States of America
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Texas
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Vienna
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Bosnia and Herzegovina
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Foca
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Brazil
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Rio Grande do Sul
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Brazil
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So Paulo
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Canada
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Alberta
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Canada
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Ontario
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Colombia
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Antioquia
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Colombia
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Cundinamarca
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Colombia
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Santander
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Colombia
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Barranquilla
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Czech Republic
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Brno
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Czech Republic
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Chomutov
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Czech Republic
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Havlickuv Brod
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Czech Republic
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Jihlava
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Czech Republic
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Jindrichuv Hradec
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Czech Republic
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Klatovy
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Czech Republic
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Liberec
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Czech Republic
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Prague
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Czech Republic
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Trebic
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Copenhagen
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Frederiksberg
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Herlev
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Horsholm
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Silkeborg
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Kohtla-Jarve
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Tallinn
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Tartu
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Finland
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Jyvaskyla
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Finland
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Oulu
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Germany
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Mainz
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Germany
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Marburg
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Hungary
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Budapest
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Debrecen
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Gyor
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Kecskemet
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Szeged
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Szekesfehervar
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Szekszard
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Szolnok
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Valmiera
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Kaunas
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Timis
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Cluj
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Omsk
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Presov
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Pretoria
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Lviv
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Surrey
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London
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United Kingdom
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Northampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Europe B.V.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Use Central Contact
Address 0 0
Astellas Pharma Europe B.V.
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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00902928