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A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery (ONYX-3)

Primary Purpose

Venous Thromboembolism, Arthroplasty, Replacement, Hip

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YM150
enoxaparin
Sponsored by
Astellas Pharma Europe B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring Elective hip replacement surgery, Factor Xa, Venous Thromboembolism, Thrombosis, Anticoagulants, Prevention, YM150

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is scheduled for elective hip replacement surgery

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

1. YM150, Dose X, twice daily

2, YM150, Dose X, once daily

3. YM150, Dose Y, twice daily

4. YM150, Dose Y, once daily

5. Enoxaparin

Arm Description

Outcomes

Primary Outcome Measures

Incidence of symptomatic Venous Thromboembolisms and death from all causes

Secondary Outcome Measures

Incidence of all Venous Thromboembolic events
Incidence of Bleeding events

Full Information

First Posted
April 30, 2009
Last Updated
October 5, 2015
Sponsor
Astellas Pharma Europe B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT00902928
Brief Title
A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery
Acronym
ONYX-3
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Europe B.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Arthroplasty, Replacement, Hip
Keywords
Elective hip replacement surgery, Factor Xa, Venous Thromboembolism, Thrombosis, Anticoagulants, Prevention, YM150

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1992 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. YM150, Dose X, twice daily
Arm Type
Experimental
Arm Title
2, YM150, Dose X, once daily
Arm Type
Experimental
Arm Title
3. YM150, Dose Y, twice daily
Arm Type
Experimental
Arm Title
4. YM150, Dose Y, once daily
Arm Type
Experimental
Arm Title
5. Enoxaparin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
YM150
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
enoxaparin
Intervention Description
SC injection
Primary Outcome Measure Information:
Title
Incidence of symptomatic Venous Thromboembolisms and death from all causes
Time Frame
12 days
Secondary Outcome Measure Information:
Title
Incidence of all Venous Thromboembolic events
Time Frame
Until day 12, during the treatment period, follow-up period and entire study period
Title
Incidence of Bleeding events
Time Frame
During the treatment period, follow-up period and entire study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is scheduled for elective hip replacement surgery 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Chair
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90507
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80015
Country
United States
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
City
Ringwood East
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
City
Windsor
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
City
Linz
ZIP/Postal Code
4010
Country
Austria
City
Vienna
ZIP/Postal Code
1090
Country
Austria
City
Vienna
ZIP/Postal Code
1130
Country
Austria
City
Foca
ZIP/Postal Code
73300
Country
Bosnia and Herzegovina
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
30130-100
Country
Brazil
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90610-000
Country
Brazil
City
Sao Paulo
State/Province
So Paulo
ZIP/Postal Code
04262-000
Country
Brazil
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7R 4B7
Country
Canada
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1E 6L9
Country
Canada
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1CA
Country
Canada
City
Medellin
State/Province
Antioquia
Country
Colombia
City
Bogota
State/Province
Cundinamarca
Country
Colombia
City
Floridablanca
State/Province
Santander
Country
Colombia
City
Barranquilla
Country
Colombia
City
Brno
ZIP/Postal Code
66250
Country
Czech Republic
City
Chomutov
ZIP/Postal Code
43001
Country
Czech Republic
City
Havlickuv Brod
ZIP/Postal Code
580 22
Country
Czech Republic
City
Jihlava
ZIP/Postal Code
58633
Country
Czech Republic
City
Jindrichuv Hradec
ZIP/Postal Code
37738
Country
Czech Republic
City
Klatovy
ZIP/Postal Code
33938
Country
Czech Republic
City
Liberec
ZIP/Postal Code
46001
Country
Czech Republic
City
Prague
ZIP/Postal Code
18081
Country
Czech Republic
City
Trebic
ZIP/Postal Code
67401
Country
Czech Republic
City
Copenhagen
ZIP/Postal Code
2300
Country
Denmark
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
City
Horsholm
ZIP/Postal Code
2970
Country
Denmark
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
City
Kohtla-Jarve
ZIP/Postal Code
30322
Country
Estonia
City
Tallinn
ZIP/Postal Code
10611
Country
Estonia
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
City
Jyvaskyla
ZIP/Postal Code
40620
Country
Finland
City
Oulu
ZIP/Postal Code
90029
Country
Finland
City
Mainz
ZIP/Postal Code
55101
Country
Germany
City
Marburg
ZIP/Postal Code
35033
Country
Germany
City
Budapest
ZIP/Postal Code
1113
Country
Hungary
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
City
Hyderabaad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
City
Secunderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500003
Country
India
City
Secunderabad
State/Province
Andhra Prasdesh
ZIP/Postal Code
500003
Country
India
City
Baroda
State/Province
Gujarat
ZIP/Postal Code
390007
Country
India
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
City
Jamshedpur
State/Province
Jharkhand
ZIP/Postal Code
831004
Country
India
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
City
Kormangala
State/Province
Karnataka
ZIP/Postal Code
5600034
Country
India
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575001
Country
India
City
Bhopal
State/Province
Madhya Pradesh
ZIP/Postal Code
462010
Country
India
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
City
Afula
ZIP/Postal Code
18101
Country
Israel
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
City
Bologna
ZIP/Postal Code
40136
Country
Italy
City
Milano
ZIP/Postal Code
20132
Country
Italy
City
Daugavpils
ZIP/Postal Code
LV4317
Country
Latvia
City
Liepaja
ZIP/Postal Code
LV 3400
Country
Latvia
City
Riga
ZIP/Postal Code
LV 1005
Country
Latvia
City
Riga
ZIP/Postal Code
LV1004
Country
Latvia
City
Valmiera
ZIP/Postal Code
LV4201
Country
Latvia
City
Kaunas
ZIP/Postal Code
LT-44320
Country
Lithuania
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
City
Vilnius
ZIP/Postal Code
04130
Country
Lithuania
City
Gjovik
ZIP/Postal Code
2819
Country
Norway
City
Kongsvinger
ZIP/Postal Code
2226
Country
Norway
City
Lillehammer
ZIP/Postal Code
2629
Country
Norway
City
Tonsberg
ZIP/Postal Code
3116
Country
Norway
City
Tynset
ZIP/Postal Code
2500
Country
Norway
City
Glogow Malopolski
ZIP/Postal Code
36-060
Country
Poland
City
Konskie
ZIP/Postal Code
26-200
Country
Poland
City
Krakow
ZIP/Postal Code
31-913
Country
Poland
City
Lodz
ZIP/Postal Code
91-002
Country
Poland
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
City
Opole
ZIP/Postal Code
45-372
Country
Poland
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
City
Poznan
ZIP/Postal Code
61-485
Country
Poland
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
City
Warszawa
ZIP/Postal Code
02-005
Country
Poland
City
Curitiba
ZIP/Postal Code
80060-900
Country
Puerto Rico
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300736
Country
Romania
City
Bucharest
ZIP/Postal Code
021382
Country
Romania
City
Bucharest
ZIP/Postal Code
021659
Country
Romania
City
Bucharest
ZIP/Postal Code
042122
Country
Romania
City
Cluj
ZIP/Postal Code
0400132
Country
Romania
City
Craiova
ZIP/Postal Code
20116
Country
Romania
City
Iasi
ZIP/Postal Code
0700483
Country
Romania
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
City
Omsk
ZIP/Postal Code
644043
Country
Russian Federation
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
City
Banska Bysterica
ZIP/Postal Code
975 01
Country
Slovakia
City
Kosice Saca
ZIP/Postal Code
04015
Country
Slovakia
City
Presov
ZIP/Postal Code
08181
Country
Slovakia
City
Worcester
State/Province
Cape Town
ZIP/Postal Code
6850
Country
South Africa
City
Benoni
ZIP/Postal Code
1501
Country
South Africa
City
Bryanston
ZIP/Postal Code
2021
Country
South Africa
City
Port Elizabeth
ZIP/Postal Code
6014
Country
South Africa
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
City
Pretoria
ZIP/Postal Code
0083
Country
South Africa
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Castello
ZIP/Postal Code
12004
Country
Spain
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Palma Mallorca
ZIP/Postal Code
07014
Country
Spain
City
Kalmar
ZIP/Postal Code
391 85
Country
Sweden
City
Molndal
ZIP/Postal Code
41685
Country
Sweden
City
Motala
ZIP/Postal Code
591 85
Country
Sweden
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
City
Varberg
ZIP/Postal Code
43281
Country
Sweden
City
Cherkassy
ZIP/Postal Code
18009
Country
Ukraine
City
Ivano-Frankovsk
ZIP/Postal Code
76008
Country
Ukraine
City
Lviv
ZIP/Postal Code
79495
Country
Ukraine
City
Sevastopol
ZIP/Postal Code
99018
Country
Ukraine
City
Epsom
State/Province
Surrey
ZIP/Postal Code
KT18 7EG
Country
United Kingdom
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
City
Northampton
ZIP/Postal Code
NN1 5 BD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24136153
Citation
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.
Results Reference
derived
Links:
URL
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=989
Description
Link to Results on JAPIC

Learn more about this trial

A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery

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