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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
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United States of America
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Arizona
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Arkansas
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Graz
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Foca
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Presov
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London
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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
The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip replacement surgery.
Trial website
https://clinicaltrials.gov/study/NCT00902928
Trial related presentations / publications
Eriksson BI, Agnelli G, Gallus AS, Lassen MR, Prins MH, Renfurm RW, Kashiwa M, Turpie AG. Darexaban (YM150) versus enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a randomised phase IIb dose confirmation study (ONYX-3). Thromb Haemost. 2014 Feb;111(2):213-25. doi: 10.1160/TH13-04-0296. Epub 2013 Oct 17.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00902928