Trial Review

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/ct2/show/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/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
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Austria
State/province [11] 0 0
Graz
Country [12] 0 0
Austria
State/province [12] 0 0
Innsbruck
Country [13] 0 0
Austria
State/province [13] 0 0
Linz
Country [14] 0 0
Austria
State/province [14] 0 0
Vienna
Country [15] 0 0
Bosnia and Herzegovina
State/province [15] 0 0
Foca
Country [16] 0 0
Brazil
State/province [16] 0 0
Rio Grande do Sul
Country [17] 0 0
Brazil
State/province [17] 0 0
So Paulo
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Colombia
State/province [20] 0 0
Antioquia
Country [21] 0 0
Colombia
State/province [21] 0 0
Cundinamarca
Country [22] 0 0
Colombia
State/province [22] 0 0
Santander
Country [23] 0 0
Colombia
State/province [23] 0 0
Barranquilla
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Brno
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Chomutov
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Havlickuv Brod
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Jihlava
Country [28] 0 0
Czech Republic
State/province [28] 0 0
Jindrichuv Hradec
Country [29] 0 0
Czech Republic
State/province [29] 0 0
Klatovy
Country [30] 0 0
Czech Republic
State/province [30] 0 0
Liberec
Country [31] 0 0
Czech Republic
State/province [31] 0 0
Prague
Country [32] 0 0
Czech Republic
State/province [32] 0 0
Trebic
Country [33] 0 0
Denmark
State/province [33] 0 0
Copenhagen
Country [34] 0 0
Denmark
State/province [34] 0 0
Frederiksberg
Country [35] 0 0
Denmark
State/province [35] 0 0
Herlev
Country [36] 0 0
Denmark
State/province [36] 0 0
Horsholm
Country [37] 0 0
Denmark
State/province [37] 0 0
Silkeborg
Country [38] 0 0
Estonia
State/province [38] 0 0
Kohtla-Jarve
Country [39] 0 0
Estonia
State/province [39] 0 0
Tallinn
Country [40] 0 0
Estonia
State/province [40] 0 0
Tartu
Country [41] 0 0
Finland
State/province [41] 0 0
Jyvaskyla
Country [42] 0 0
Finland
State/province [42] 0 0
Oulu
Country [43] 0 0
Germany
State/province [43] 0 0
Mainz
Country [44] 0 0
Germany
State/province [44] 0 0
Marburg
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
Gyor
Country [48] 0 0
Hungary
State/province [48] 0 0
Kecskemet
Country [49] 0 0
Hungary
State/province [49] 0 0
Szeged
Country [50] 0 0
Hungary
State/province [50] 0 0
Szekesfehervar
Country [51] 0 0
Hungary
State/province [51] 0 0
Szekszard
Country [52] 0 0
Hungary
State/province [52] 0 0
Szolnok
Country [53] 0 0
India
State/province [53] 0 0
Andhra Pradesh
Country [54] 0 0
India
State/province [54] 0 0
Andhra Prasdesh
Country [55] 0 0
India
State/province [55] 0 0
Gujarat
Country [56] 0 0
India
State/province [56] 0 0
Haryana
Country [57] 0 0
India
State/province [57] 0 0
Jharkhand
Country [58] 0 0
India
State/province [58] 0 0
Karnataka
Country [59] 0 0
India
State/province [59] 0 0
Madhya Pradesh
Country [60] 0 0
India
State/province [60] 0 0
Rajasthan
Country [61] 0 0
Israel
State/province [61] 0 0
Afula
Country [62] 0 0
Israel
State/province [62] 0 0
Haifa
Country [63] 0 0
Israel
State/province [63] 0 0
Kfar Saba
Country [64] 0 0
Israel
State/province [64] 0 0
Petach Tikva
Country [65] 0 0
Israel
State/province [65] 0 0
Rehovot
Country [66] 0 0
Italy
State/province [66] 0 0
Bologna
Country [67] 0 0
Italy
State/province [67] 0 0
Milano
Country [68] 0 0
Latvia
State/province [68] 0 0
Daugavpils
Country [69] 0 0
Latvia
State/province [69] 0 0
Liepaja
Country [70] 0 0
Latvia
State/province [70] 0 0
Riga
Country [71] 0 0
Latvia
State/province [71] 0 0
Valmiera
Country [72] 0 0
Lithuania
State/province [72] 0 0
Kaunas
Country [73] 0 0
Lithuania
State/province [73] 0 0
Klaipeda
Country [74] 0 0
Lithuania
State/province [74] 0 0
Vilnius
Country [75] 0 0
Norway
State/province [75] 0 0
Gjovik
Country [76] 0 0
Norway
State/province [76] 0 0
Kongsvinger
Country [77] 0 0
Norway
State/province [77] 0 0
Lillehammer
Country [78] 0 0
Norway
State/province [78] 0 0
Tonsberg
Country [79] 0 0
Norway
State/province [79] 0 0
Tynset
Country [80] 0 0
Poland
State/province [80] 0 0
Glogow Malopolski
Country [81] 0 0
Poland
State/province [81] 0 0
Konskie
Country [82] 0 0
Poland
State/province [82] 0 0
Krakow
Country [83] 0 0
Poland
State/province [83] 0 0
Lodz
Country [84] 0 0
Poland
State/province [84] 0 0
Lublin
Country [85] 0 0
Poland
State/province [85] 0 0
Opole
Country [86] 0 0
Poland
State/province [86] 0 0
Otwock
Country [87] 0 0
Poland
State/province [87] 0 0
Poznan
Country [88] 0 0
Poland
State/province [88] 0 0
Warszawa
Country [89] 0 0
Puerto Rico
State/province [89] 0 0
Curitiba
Country [90] 0 0
Romania
State/province [90] 0 0
Timis
Country [91] 0 0
Romania
State/province [91] 0 0
Bucharest
Country [92] 0 0
Romania
State/province [92] 0 0
Cluj
Country [93] 0 0
Romania
State/province [93] 0 0
Craiova
Country [94] 0 0
Romania
State/province [94] 0 0
Iasi
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Kazan
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Moscow
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Nizhny Novgorod
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Novosibirsk
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Omsk
Country [100] 0 0
Russian Federation
State/province [100] 0 0
Samara
Country [101] 0 0
Russian Federation
State/province [101] 0 0
St. Petersburg
Country [102] 0 0
Russian Federation
State/province [102] 0 0
Yaroslavl
Country [103] 0 0
Slovakia
State/province [103] 0 0
Banska Bysterica
Country [104] 0 0
Slovakia
State/province [104] 0 0
Kosice Saca
Country [105] 0 0
Slovakia
State/province [105] 0 0
Presov
Country [106] 0 0
South Africa
State/province [106] 0 0
Cape Town
Country [107] 0 0
South Africa
State/province [107] 0 0
Benoni
Country [108] 0 0
South Africa
State/province [108] 0 0
Bryanston
Country [109] 0 0
South Africa
State/province [109] 0 0
Port Elizabeth
Country [110] 0 0
South Africa
State/province [110] 0 0
Pretoria
Country [111] 0 0
Spain
State/province [111] 0 0
Barcelona
Country [112] 0 0
Spain
State/province [112] 0 0
Castello
Country [113] 0 0
Spain
State/province [113] 0 0
Madrid
Country [114] 0 0
Spain
State/province [114] 0 0
Palma Mallorca
Country [115] 0 0
Sweden
State/province [115] 0 0
Kalmar
Country [116] 0 0
Sweden
State/province [116] 0 0
Molndal
Country [117] 0 0
Sweden
State/province [117] 0 0
Motala
Country [118] 0 0
Sweden
State/province [118] 0 0
Stockholm
Country [119] 0 0
Sweden
State/province [119] 0 0
Varberg
Country [120] 0 0
Ukraine
State/province [120] 0 0
Cherkassy
Country [121] 0 0
Ukraine
State/province [121] 0 0
Ivano-Frankovsk
Country [122] 0 0
Ukraine
State/province [122] 0 0
Lviv
Country [123] 0 0
Ukraine
State/province [123] 0 0
Sevastopol
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Surrey
Country [125] 0 0
United Kingdom
State/province [125] 0 0
London
Country [126] 0 0
United Kingdom
State/province [126] 0 0
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/ct2/show/NCT00902928
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00902928